PharmaNetra(TM) Enterprise -- 21 CFR GMP Suite

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Executive Dashboard

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Executive Dashboard

Site: -- · Configure site details in Settings

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Welcome to PharmaNetra(TM) Enterprise -- Fresh Installation

Begin by clicking Site Setup to configure your site details, then add your Products, Personnel, and Equipment. All modules are empty and ready for your real data.

⚙

Batches In Process

Add batches in Production module

⏳

Pending QA Release

Batches awaiting QP sign-off

✓

Approved RM Lots

Add RM in Warehouse module

⚠

Open CAPA Actions

Log deviations in CAPA module

Recent Batch Activity

Batch No.	Product	Stage	Progress	QA Status	Date
No batches yet -- initiate your first batch to see activity here

GMP Compliance Index

📋

21 CFR 211

COVERED

💻

21 CFR Pt.11

COVERED

📌

Schedule M

COVERED

🌍

WHO GMP

COVERED

🔍

PIC/S

COVERED

🇪🇺

EU Annex 11

COVERED

📊

ICH Q10

COVERED

🏅

GAMP 5

FRAMEWORK

Vendor Records0 added

Equipment Records0 added

RM Lots Expired

RM Expiring 30d

CAPA Overdue

Open OOS

Open Complaints

Stability Due 7d

LIMS WO Pending

Cal. Overdue

LIMS WO Overdue

Cal. Due 30d

SOP Review Due

SOPs Registered0 added

Open Deviations0

Warehouse Summary

RM Approved Lots0

In Quarantine0

Expiry Within 30 Days0

FG Batches Released0

Quality Actions

Open Deviations0

Open CAPAs0

OOS / OOT Open0

Product Complaints0

Compliance Docs

Active SOPs0

SOPs Due for Review0

Validation Records0

Stability Studies0

👤 Current Session

Logged in as: --

Role: --

Session timeout: 8 hours (21 CFR Part 11)

Production & BMR Execution

21 CFR 211.188 · Revised Schedule M Cl.16 · WHO TRS 961 Annex 2 · PIC/S PE 009-16

Active Batches

BMR Execution

Production Schedule

Environmental Monitoring

Yield Reconciliation

SVP Manufacturing

Tablet Mfg

Capsule Mfg

Dry Suspension

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How to Start

Click ＋ Initiate New Batch to create a batch. Each batch links to an approved BMR. Operators sign each step electronically per 21 CFR Part 11.

All Batches

Batch No.	Product	Batch Size	Mfg. Date	Stage	Progress	Status	Actions
No batches initiated yet. Click ＋ New Batch to begin.

Planned

In Progress

QA Review

Released

Production Schedule

Planned Date	Product	Batch No.	Room / Line	Status
No batches scheduled. Add batches using ＋ New Batch.

Environmental Monitoring Log

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Per Schedule M & ISO 14644

Log temperature, humidity, differential pressure, and particle counts for each room at each shift. All readings timestamped and audit-trailed.

Date / Time	Room / Zone	ISO Class	Temp (°C)	RH (%)	DP (Pa)	ACH	Particles /m³	TAMC CFU	Status	LIMS WO
No environmental readings logged yet.

Yield Reconciliation Records

Batch No.	Product	Theoretical Yield	Actual Yield	Rejected	Retention	% Yield	Limit	Status
No yield records. Add records after batch completion.

SVP -- Dry Powder Injection Manufacturing

EU GMP Annex 1 · 21 CFR §211.113 · Schedule M Cl.16 · WHO TRS 961 · ICH Q6A

Active SVP Batch:

Environmental Monitoring Log -- SVP Filling

Date/Time (IST)	Location	Grade	Test Type	Result (CFU)	Limit	Status	Analyst
No EM entries. Add after each monitoring point.

IPQA / IPQC

In-Process Quality Assurance & Control · Schedule M Cl.16 · WHO TRS 961 · PIC/S PE 009-16

IPQC Checks

Line Clearance

PAT / Process Log

🔬

IPQC Sampling Protocol

Record in-process test results at defined intervals per BMR. Results are linked to the batch and audit-trailed. Failures trigger automatic deviation flag.

IPQC Test Results

Date/Time	Batch No.	Stage	Test Parameter	Specification	Result	Status	Analyst
No IPQC results recorded yet. Select a batch and record in-process results.

Line Clearance / Area Clearance Certificates

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Line Clearance Requirement

Per 21 CFR 211.130 & Schedule M Cl.16: All areas and equipment must be cleared of previous product, labels, and documents before starting a new batch. IPQA sign-off mandatory.

Certificate No.	Area / Equipment	Batch Cleared For	Product Cleared For	Previous Product	Date / Time	IPQA Officer	Checklist	Status
No line clearance records. Issue a certificate before each batch start.

Process Analytical Technology (PAT) / In-Process Log

Timestamp	Batch No.	Process Step	Parameter	Target / Limit	Actual Value	Unit	Status
No process parameters logged yet.

🏭 Warehouse & Stores Management

Schedule M 2023 Cl.19 · 6 Stores · FEFO · Quarantine · Issue & Receipt · 21 CFR Part 11 Audit Logged

🧪 Store 1 -- Raw Material Store RMS

APIs · Excipients · Pharmacopoeial Materials

Total Lots

Expiring 30d

Quarantine

📦 Store 2 -- Packing Material Store PMS

Primary PM · Secondary PM · Tertiary PM

Total Items

Approved

Quarantine

🔧 Store 3 -- Engineering Material Store EMS

Eng. Materials · Electrical · General Stores

Total Items

Low Stock

PO Pending

✅ Store 4 -- Finished Goods Store FGS

Manufactured FG · Bought-out FG · WFI · FEFO

Total SKUs

Expiring 90d

Approved

⚙ Store 5 -- Machine Parts Store MPS

Machine Parts · Dyes & Punches · Change Parts

Total Parts

Critical Low

Due Inspect

🔬 Store 6 -- QC & Micro Store QMS

Chemicals · Reagents · Media · Cultures · Consumables

Total Items

Expiring 30d

Low Stock

Store

🧪 API Store -- Active Pharmaceutical Ingredients

Schedule M Cl.19 · WHO GMP · Quarantine on receipt · FEFO order · CoA mandatory

Total Lots

Approved

Quarantine

Expiring 30d

Issued (total)

RM Code	API Name (Pharmacopoeial)	Grade	Lot No.	Qty	Unit	Mfg Date	Expiry / Retest	Supplier	CoA Ref	GRN No.	Location	Status	Actions
No APIs received yet. Click + Receive API above.

Code	Excipient Name	Grade/Std	Function	Lot No.	Qty	Unit	Supplier	Mfg Date	Expiry	Storage Cond.	Location	Status	Actions
No excipients received yet.

PM Code	Description	Specification	PM Type	Lot No.	Qty	Unit	Supplier	Received Date	CoA Ref	AR No.	Location	Status	Actions
No primary packaging materials received yet.

PM Code	Description	Artwork Version	Lot No.	Qty	Unit	Supplier	Received Date	CoA Ref	AR No.	Location	Status	Actions
No secondary packaging materials received yet.

PM Code	Description	Size/Spec	Lot No.	Qty	Unit	Supplier	Received Date	Location	Status	Actions
No tertiary packaging materials received yet.

Part Code	Description	Make / OEM	Part No.	Equipment Used In	Qty	Unit	Min Stock	Location	Status	Actions
No engineering spares.

Item Code	Description	Make / Model	Rating / Spec	Qty	Unit	Supplier	Location	Status	Actions
No electrical items.

Item Code	Item Name / Description	Category	Make / Brand	Qty	Unit	Supplier	Min Stock	Location	Status	Actions
No general store items.

Type	Product	SKU	Pack Size	Batch No.	Qty	UOM	Mfg Date	Expiry	Release Date	Released By	CoA Ref	Location	Status	Actions
No finished goods. Add Opening Stock or release batches via QA.

Item Code	Product Name	Strength	Manufacturer	Batch No.	Qty	Pack Size	Mfg Date	Expiry	Invoice No.	Received Date	CoA Ref	Location	Status	Actions
No bought-out FG items received yet.

Part Code	Part Description	Make / OEM	Part No.	Equipment	Qty	Unit	Min Stock	Supplier	Location	Criticality	Status	Actions
No machine parts in store. Click + Add Machine Part above.

Item Code	Description	Type	Size / Shape	Material	Machine Compatible	Qty Sets	Condition	Last Inspected	Supplier	Status	Actions
No dyes/punches in store.

Part Code	Part Description	Machine / Equipment	Part No.	Qty	Unit	Condition	Pack Size / Format	Last Used	Supplier	Status	Actions
No change parts in store.

Chem Code	Chemical / Reagent Name	Grade	CAS No.	Lot No.	Qty	Unit	Supplier	Mfg Date	Expiry	Storage	Location	Status	Actions
No chemicals/reagents in store. Click + Add Chemical/Reagent.

Item Code	Media / Culture Name	Type	Manufacturer	Lot No.	Qty	Unit	Prepared / Received Date	Expiry	Growth Promotion Result	Storage Temp	Location	Status	Actions
No micro media or cultures in store.

Code	Item Name	Category	Brand / Make	Lot / Batch	Qty	Unit	Supplier	Expiry	Location	Status	Actions
No lab consumables in store.

Move No.	Date & Time	Store	Type	Item Code	Item Name	Qty	Unit	From / To	Issued To / Received From	Reference	Entered By
No movements recorded yet.

QC Laboratory

21 CFR 211.160-194 · IP/BP/USP Pharmacopoeial Methods · ICH Q2(R1) · Schedule M Cl.20 · WHO GMP Ch.6

📄 Specification

📋 STP Library

🧪 RM Testing

💊 Finished Product

💧 Water Testing

⚗ Solution Prep

🦠 Microbiological

🌡 Environmental Monitoring

🧪 Content Uniformity

📓 Log Books

🧴 Chemicals & Stock

🔬 QC Lab Instruments

📄 QC Specification

RM / PM / FP Specification Library

Spec No.	Type	Sub-type	Material Name	Code	Grade	Rev.	Effective	Review Due	Status	Actions
No specifications. Click + New Specification.

Water Specification Library

Spec No.	Water Type	Version	Supersedes	Reference	Effective	Review Due	Status	Actions
No water specifications.

Specifications Under Review

Spec No.	Type	Name	Version	By	On	Status	Action
No specifications pending review.

Pending Approval -- QC Manager

Spec No.	Type	Name	Version	Reviewed By	Date	Status	Action
No specifications pending approval.

Standard Testing Protocols (STP) Library

📋

STP -- Standard Testing Protocol

Define the complete pharmacopoeial test procedure for each material. When an analyst opens a test, the STP auto-loads showing exact tests, specifications, reagents, and reference methods. Follows IP/BP/USP Chapter requirements.

STP No.	Material / Product Name	Category	Pharmacopoeia	Version	Parameters	Approved By	Effective Date	Status	Actions
No STPs defined. Click ＋ Add STP to create testing protocols for your materials.

Raw Material Analysis Register

🧪

Opening a new analysis auto-loads the STP for that material

Pharmacopoeial tests: Description · Identification (IR/HPLC) · Assay · Loss on Drying · Water Content (KF) · Residue on Ignition · Heavy Metals · Related Substances · Microbial Limits · Particle size (where applicable).

AR No.	Sample ID	Date	Material Name	Grade	Lot No.	Supplier	STP Ref	Tests Done	Analyst	Result	Actions
No RM analyses recorded.

Finished Product Analysis Register

AR No.	Date	Product	Batch No.	STP Ref	Avg Wt	Hardness	Disint.	Dissolution	Assay %	Analyst	Result	COA No.	Actions
No finished product analyses recorded.

Water System Testing Log -- PW / WFI

💧

Water Testing -- USP <645> / <643> / <61> / <62> / <85> / IP 2022

Daily: pH, Conductivity, TOC. Weekly: TAMC, TYMC. WFI only: Endotoxin (≤0.25 EU/mL). Alert limits ≤80%, Action limits = specification limit. Trend analysis mandatory.

Date	Time	Sampling Point	Water Type	pH	Conductivity (µS/cm)	TOC (ppb)	TAMC (CFU/mL)	TYMC (CFU/mL)	Endotoxin (EU/mL)	Analyst	Status	Actions
No water test records. Log daily PW/WFI readings from each sampling point.

Solution Preparation Log

⚗

Solution Preparation -- Reagents, Standards, Buffers, Mobile Phase

Every solution prepared in QC lab must be logged: preparation date, expiry, concentration, standardisation result (where applicable), prepared by, and checked by. Linked to chemical stock consumption.

Soln. No.	Date of Preparation	Solution Name	Type	Concentration	Volume (mL)	Solvent Used	Chemicals Used	Expiry	Factor / Standardised Value	Prepared By	Checked By	Actions
No solutions logged. Record all reagent and standard preparations.

Microbiological Testing Register

Sample ID	Date	Sample Type	Batch / Lot	TAMC Spec	TAMC Result	TYMC Spec	TYMC Result	Pathogens	Incubation End	Analyst	Status	Actions
No microbiological tests recorded.

Environmental Monitoring Log (Room / Grade)

🌡

Environmental Monitoring -- EU GMP Annex 1 / ISO 14644 / Schedule M Cl.6

Log room classification readings: temperature, relative humidity, differential pressure (with alert/action limits), ACPH, viable/non-viable particle counts (TAMC/TYMC with alert/action limits). Trend and excursions reviewed per SOP.

Room	Grade	Date	Temp	RH	DP	ACPH	Particle Count	TAMC	TYMC	Recorded By	Status	Actions
No Environmental Monitoring readings recorded.

Product	Dosage Form	Facility Block	Status	Action
No Content Uniformity tests recorded.

HPLC Log Entries

Balance Log Entries

UV/Vis Log Entries

General Entries

QC Instrument Log Books

📓

Log Book Entries -- 21 CFR Part 11 compliant

Record every instrument use: date/time, analyst, test performed, sample ID, system suitability result (SST), column used, mobile phase batch, standards used, result summary. For balances: daily sensitivity check, linearity check, tare verification.

Entry No.	Date & Time	Instrument	Instrument ID	Test / Activity	Sample ID / AR No.	SST Result	Analyst	Supervisor Check	Remarks	Actions
No log entries. Record each instrument use session.

Chemicals Registered

Low Stock Alerts

Expiring <30 Days

Usage Entries Today

QC Chemicals & Consumables Stock Ledger

🧴

Chemical Stock Register -- Schedule M Cl.20 / WHO GMP Ch.6.7

Track all chemicals, reagents, reference standards (RS), working standards (WS), solvents, consumables. Every dispensing is logged against an AR number. Expiry and reorder alerts auto-calculated.

Chem. Code	Name / Grade	Category	Manufacturer	Lot / Batch No.	Pack Size	Opening Stock	Current Stock	Unit	Reorder Level	Expiry	Storage	Status	Actions
No chemicals registered. Add your QC lab chemicals, reagents, and consumables.

Chemical Usage / Dispensing Ledger

Date	Chemical Name	Lot No.	Qty Used	Unit	Used For (AR No. / Test)	Balance After	Dispensed By	Checked By	Remarks
No usage records. Log every chemical dispensing against an analysis reference.

QC Instruments

Calibration Overdue

PM Due <30 Days

Fully Qualified

QC Laboratory Instrument Register

Equip. ID	Instrument Name	Make / Model	Serial No.	Location	IQ/OQ/PQ Status	Last Calibration	Next Cal. Due	Cal. Status	Last PM	Next PM Due	PM Status	Cal. Agency	Cert. No.	Actions
No QC equipment registered.

Preventive Maintenance (PM) Schedule & History

🔧

PM Records -- 21 CFR 211.68 / Schedule M Cl.12

All PM activities must be documented with: service engineer details, parts replaced, parameter checks performed, and sign-off by QC/Engineering. Next PM date must be updated after each service.

PM No.	Date Done	Instrument	Equip. ID	PM Type	Service Engineer	Company	Activities Performed	Parts Replaced	Next PM Due	Done By	Verified By	Actions
No PM records. Log all preventive maintenance activities here.

Quality Assurance

Batch Release · Change Control · APR · ICH Q10 PQS · QP Responsibilities

Batch Release

Change Control

Annual Product Review

Mock Recall

✅

QP Batch Release -- 21 CFR 211.192 & Schedule M Cl.16.11

Before releasing any batch, verify: BMR complete · All IPQC checks passed · QC COA issued · No open deviations · Yield reconciliation passed · Label reconciliation 100% · Stability samples stored. QP e-signature required per 21 CFR Part 11.

Batch Release Queue

Batch No.	Product	Mfg. Date	BMR ✓	QC COA ✓	Deviations	Yield ✓	QP Review	Status	Actions
No batches pending release. Batches appear here after manufacture is complete.

Change Control Register

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Change Control Categories

Minor: No regulatory impact. Major: Requires process revalidation. Critical: Regulatory submission/variation required. All changes need risk assessment per ICH Q10.

CC No.	Description of Change	Initiated By	Risk Level	Regulatory Impact	Date Initiated	Target Date	Status	Actions
No change controls initiated. Log all process, equipment, and material changes.

Change Control Trends — by Type & Year

📈

CC Trend Analysis -- 21 CFR 211.180(e) · ICH Q10 · Sch M

Annual trending of change controls by type (from the Type segment of each CC No.) supports management review & continual improvement.

Open the Change Control tab to load trends…

Annual Product Review (APR) Register

📊

APR Content Requirements -- 21 CFR 211.180(e) & Schedule M

Each APR must include: All batches manufactured · OOS/OOT summary · Deviation/CAPA review · Stability data review · Supplier change review · Process trend analysis · Validation status · Complaint summary · Regulatory update review.

APR No.	Product	Review Period	Total Batches	Pass Rate	Deviations	Prepared By	Approved By (QP)	Date
No APR records. Create annual reviews after 12 months of production data.

Mock Recall Exercise Register

🔁

Mock Recall Requirement -- WHO Guidelines

Conduct at least one mock recall exercise per year per product family. Target: ≥98% product traceability within 4 hours. Document distributor contact details, product recovery, and time-to-completion.

Exercise No.	Product / Batch Tested	Date	Time to Trace (min)	% Recovery	Distributors Contacted	Regulatory Notif.	Result
No mock recall exercises conducted yet.

Pharmacovigilance (ICSR)

ICH E2A/E2D · PvPI (IPC/CDSCO) · NDCT Rules 2019 · WHO-UMC causality · patient data de-identified (DPDP Act 2023)

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Expedited reporting (ICH E2D)

Serious cases: fatal / life-threatening report due within 7 days; other serious within 15 days of receipt. The register flags overdue cases. Patient identifiers must NOT be recorded (initials/age/sex/weight only).

ICSR / Adverse Event Register

PV Case No.	Suspect Product	Adverse Event	Seriousness	Causality	Report Due	Status	Reported To	Actions
No ICSR / adverse event cases logged.

Incident Reporting

ICH Q10 PQS · 21 CFR 211.192 · Sch M · Unplanned events, near-misses & quality incidents

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Incident vs Deviation

An Incident captures an unplanned event or near-miss. If it has potential product-quality impact, flag it for escalation to a formal Deviation/CAPA.

Incident Register

Incident No.	Area / Location	Description	Classification	Escalate	Reported By	Days Open	Status	Actions
No incidents logged. Record unplanned events, near-misses, and quality incidents.

Deviations & CAPA

ICH Q10 PQS · FDA CAPA Guidance · WHO TRS 961 · Ishikawa / 5-Why Root Cause Analysis

📋 Deviation Register

⚡ CAPA Tracker

🧠 Root Cause Analysis

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Deviation Classification

Minor: No product quality impact. Major: Potential quality impact, investigation required. Critical: Product safety/efficacy impact, batch quarantine, regulatory notification may be required.

Deviation Register

Dev. No.	Batch / Area	Description	Severity	Root Cause	CAPA Due	Days Open	Status	Actions
No deviations logged. Record all process deviations, equipment failures, and specification excursions.

CAPA Summary

Total Open0

Overdue0

Closed This Month0

Critical Open0

⚡

CAPA -- Corrective & Preventive Action Workflow

Each deviation auto-generates a CAPA task. CAPAs are tracked through: Initiation -> Root Cause -> Action Plan -> Implementation -> Verification -> Closure. Effectiveness review required 3 months post-closure per ICH Q10.

CAPA Register

CAPA No.	Source (Dev No.)	Category	Problem Statement	Root Cause	Corrective Action	Preventive Action	Responsible	Target Date	Verification Date	Effectiveness	Status
No CAPAs initiated. CAPAs are auto-generated from deviation entries.

🧠

Root Cause Analysis Tools

This module supports Ishikawa (Fishbone) Diagram -- 6M analysis (Man, Machine, Method, Material, Measurement, Mother Nature) -- and 5-Why Analysis for systematic RCA per ICH Q10 and FDA CAPA guidance.

5-Why Analysis Register

RCA No.	Linked Dev.	Problem	Why 1	Why 2	Why 3	Why 4	Why 5 (Root Cause)	Analyst	Date
No RCA records. Complete 5-Why analysis for all major and critical deviations.

Ishikawa 6M Summary

RCA No.	Man	Machine	Method	Material	Measurement	Mother Nature	Primary Cause Category
No Ishikawa records yet.

OOS / OOT Investigations

21 CFR 211.192 · FDA OOS Guidance (2006) · WHO TRS 929 · Phase I (Lab) / Phase II (Full) Protocol

⚠ OOS Register

📈 OOT Trend

🔍 Investigations

⚠

Two-Phase OOS Investigation Protocol -- FDA 2006 Guidance

Phase I (Lab Investigation): Must begin within 1 business day. Check for analyst error, instrument malfunction, calculation error. Phase II (Full Investigation): If Phase I inconclusive -- manufacturing investigation, additional testing. All results and decisions audit-trailed per 21 CFR Part 11.

OOS / OOT Register

OOS/OOT No.	Batch	Product	Test Parameter	Result	Specification	Analyst	Phase	Investigation Status	Outcome
No OOS/OOT reports. Log when any QC result falls outside specification or shows unexpected trend.

📈

OOT -- Out-of-Trend Analysis

OOT results do not fail specification but show an unexpected trend. Early detection prevents OOS results. Apply statistical process control (SPC) -- Westgard rules, control charts -- to monitor trends per USP <1010> and ICH Q10.

OOT Trend Register

OOT No.	Product	Batch	Parameter	Trend Type	Values (last 5)	Control Limit	Action Taken	Analyst	Date	Status
No OOT trends recorded. Monitor parameters for early trend signals.

Phase I -- Lab Investigation Records

ℹ

Phase I must be initiated within 1 business day. Document: sample ID check, calculation verification, instrument qualification status, reagent/standard expiry, environmental conditions during analysis.

OOS No.	Phase	Analyst Error?	Instrument Issue?	Calculation Error?	Phase I Conclusion	Phase II Required?	Investigator	Completion Date
No investigation records. Begin Phase I for all open OOS.

Stability Studies

ICH Q1A(R2) · Q1B (Photostability) · Q1D (Bracketing/Matrixing) · WHO TRS 953 Annex 2

🧪 Study Register

📊 Data Entry

📅 Pull Schedule

📈

ICH Q1A(R2) Storage Conditions

Long-term: 25°C/60%RH (Zone I/II) or 30°C/65%RH (Zone III/IV) -- 12, 24, 36 months. Intermediate: 30°C/65%RH -- 6, 9, 12 months. Accelerated: 40°C/75%RH -- 3, 6 months. Place 3 primary batches per product at initiation of stability program.

Stability Study Register

Study No.	Product	Batch	Condition	Chamber	Initiated	T=0	3M	6M	9M	12M	24M	36M	Shelf Life	Action
No stability studies. Initiate for each new product and any significant change.

ℹ

Stability Data Entry

Enter test results for each time-point pull. Parameters include: Assay (%), Related Substances, Dissolution, Hardness, Friability, Moisture content (LOD), Appearance, pH, Microbial limits. Results are compared to specification and trending is automatic.

Stability Test Results Entry

Study No.	Product	Batch	Storage Condition	Time Point	Pull Date	Assay (%)	RS (Total)	Dissolution (%)	Appearance	pH	Moisture	Result	Analyst
No stability time-point data entered yet.

📅

Sample Pull Schedule

Upcoming stability sample pulls based on initiated studies. Pulls are auto-calculated from initiation date at ICH Q1A(R2) required intervals. Overdue pulls highlighted in red.

Upcoming Stability Pulls (Next 90 Days)

Study No.	Product	Batch	Condition	Time Point	Due Date	Status	Analyst Assigned
No upcoming pulls. Initiate stability studies to auto-generate pull schedule.

Product Complaints & Pharmacovigilance

21 CFR 211.198 · Schedule M Cl.18 · WHO PV Guidelines · MedDRA Coding

📨 Complaints

💉 Pharmacovigilance / ADR

🚨 Recall Assessment

📨

Complaint Handling -- 21 CFR 211.198

All complaints must be reviewed and investigated. Serious adverse events must be reported to regulatory authority within 15 days (MedWatch/ICSRs). Maintain records for 1 year beyond expiry date.

Product Complaint Register

Complaint No.	Product / Batch	Nature of Complaint	Source	MedDRA Code	Serious?	Date Received	Investigation	Regulatory Report	Status
No product complaints recorded.

⚕

Pharmacovigilance -- Adverse Drug Reaction (ADR) Reporting

All suspected ADRs must be documented and reported. Serious unexpected ADRs: report within 15 days to CDSCO/FDA. Fatal/life-threatening: 7-day expedited report. Annual PSUR (Periodic Safety Update Report) mandatory for approved drugs.

ADR / ICSR Register

ICSR No.	Product	Batch	Reporter	Patient Age/Sex	Adverse Event	MedDRA PT	Seriousness	Causality	Report Sent	Status
No ADR/ICSR records. Log all suspected adverse drug reactions.

🚨

Recall Assessment & Classification

Class I: Serious health hazard -- immediate recall. Class II: Temporary/reversible health consequence. Class III: Unlikely to cause health consequence. Report to CDSCO/FDA within 3 days of decision. Effectiveness check required.

Recall Assessment Register

Assessment No.	Complaint / ADR Ref	Product	Batch(es)	Health Hazard Eval.	Recall Class	Decision	Qty in Market	Qty Recovered	Status
No recall assessments. Assessments are triggered from critical complaints or ADRs.

MFR / BMR / BPR Library

21 CFR 211.188 · Schedule M Cl.16 · WHO TRS 961 Annex 2 · PIC/S PE 009-16 · Version Controlled

📋 MFR Templates (Master Recipe)

📄 BPR Stage Tracker (retired)

⚙ BMR Execution (Batch Mfg Record)

📦 BPR Execution (Batch Pkg Record)

🧪 Master Formula (BoM)

📋

BMR Mandatory Elements -- 21 CFR 211.188

Each BMR must contain: Product name, strength & code · Batch number & size · Theoretical yield with limits · Complete BoM with lot numbers · Step-by-step instructions · Critical process parameters · IPQC check points with specs · Equipment IDs with clean status · Signature/date lines at every step · Yield reconciliation section · Deviation log section.

Approved MFR Templates (Master Recipes)

MFR Ref. No.	Product Name	Strength	Dosage Form	Batch Size	BoM Summary	Version	Approved By	Effective Date	Status	Last Edited	Actions
No BMR templates. Create templates before initiating production batches.

Regulatory Coverage -- This System

21 CFR Part 211.188 (BMR elements)COVERED

21 CFR Part 11 (e-signatures & audit trail)COVERED

Revised Schedule M 2023 -- Cl.16COVERED

WHO TRS 961 Annex 2 (GMP Guide)COVERED

PIC/S PE 009-16 (GMP Guide)COVERED

EU GMP Annex 11 (Computerised Systems)COVERED

ICH Q10 (Pharmaceutical Quality System)COVERED

GAMP 5 (CSV Framework)FRAMEWORK READY

⚠

Retired -- Legacy BPR Stage Tracker (read-only)

This single-stage tracker has been superseded by the full executable batch records. Use the ⚙ BMR Execution tab for manufacturing and the 📦 BPR Execution tab for packaging -- both provide dispensing/PM reconciliation, in-process QC, yield, per-step Part 11 e-signatures and QA review/release.
Historical records below remain available for reference. New entries are disabled here.

BPR -- Batch Production Record Execution

Select Active Batch ★

ℹ

Select an active batch above to load its Batch Production Record for execution.

All BPR Records (Executed)

Batch No.	Product	BMR Ref.	Mfg. Date	Stage	Supervisor	IPQA	Status	Actions
No BPR records. Initiate a batch in Production module first, then execute here.

⚙

Executable Batch Manufacturing Record (BMR)

Issue a per-batch BMR from an approved MFR template. The BoM and theoretical yield are seeded automatically; operators then execute dispensing, process steps, in-process QC and yield reconciliation with per-step e-signatures (21 CFR 211.188 · Schedule M Cl.16 · 21 CFR Part 11).

Issue BMR from Approved MFR

Approved MFR Template ★

Batch No. ★

Batch Size (optional override)

Executable BMR Register

BMR No.	MFR Ref.	Product	Batch No.	Batch Size	BoM	Issued By	Status	Actions
No executable BMRs issued. Select an approved MFR + batch above and click Issue BMR.

📦

Executable Batch Packaging Record (BPR)

Issue a packaging record from a Completed BMR (manufacture-before-pack). Records line clearance, packaging-material reconciliation, coding/overprinting verification, in-process packaging checks and yield, with e-signatures (21 CFR 211.130 · Schedule M · Part 11).

Issue BPR from Completed BMR

Completed BMR (batch to pack) ★

Packaging Order No. (optional)

Executable BPR Register

BPR No.	Source BMR	Product	Batch No.	Pkg Order	PM Lines	Issued By	Status	Actions
No executable BPRs. Select a Completed BMR above and click Issue BPR.

📦 BPR Execution (Packaging)

Line clearance · PM reconciliation · coding · in-process checks · yield · 21 CFR 211.130 · Part 11

1. Line Clearance (pre-packaging)

Packaging Line ID

Previous Product Cleared

No Stray Materials Check

Done By

Checked By (IPQA)

2. Packaging Materials Reconciliation

Add each packaging material. Reconciliation % = (used+returned+damaged+destroyed)/issued; flagged if >1% off 100%. Sign verified-by.

Material	Issued	Used	Returned	Damaged	Destroyed	Recon %	Verified By
No packaging materials added.

3. Coding / Overprinting Verification

Batch No. (printed)

Mfg Date

Exp Date

MRP

Barcode / GTIN

Verified Specimen Ref

Coding Checked By

4. In-Process Packaging Checks

Check	Spec	Observed	Result	Analyst	Status
No checks added.

5. Yield / Reconciliation

Theoretical Units

Units Packed

Rejections

% Reconciliation

6. Summary & Disposition

Packed By

Current Status

Remarks

Packaging Head Sign-off (submit for QA)

⚙ BMR Execution

Dispensing reconciliation & line clearance · 21 CFR 211.188 · Part 11 e-sign

1. Equipment & Line Clearance (pre-manufacturing)

Add one entry per stage / area / equipment train requiring clearance (e.g. Dispensing, Granulation, Compression).

2. Dispensing / BoM Reconciliation

Enter actual dispensed quantity, AR no., balance ID; sign weighed-by & verified-by. Deviation >2% is flagged.

Code	Material	Std Qty	Actual	AR No.	Balance	Dev %	Weighed / Verified (e-sign)
Open a BMR to load its seeded materials.

3. Manufacturing Process Steps

Seeded from the approved MFR. Record actual parameter, equipment, time; sign done-by & checked-by.

#	Step (CPP)	Actual Param	Equip	Start	End	Done-By	Checked-By
Open a BMR to load steps.

4. In-Process Quality Control (IPQC)

Seeded from MFR specifications. Record observed result, pass/fail, analyst.

Test	Spec / Limit	Observed	Result	Analyst	Status
Open a BMR to load IPQC checks.

5. Yield Reconciliation

Theoretical Yield

Actual Yield

% Yield

6. Batch Summary & Disposition

Manufactured By

Checked By (Production)

Current Status

Batch Remarks / Disposition Notes

Production Head Sign-off (submit for QA)

Process steps, in-process QC, yield reconciliation and review/release ship in subsequent phases. Saving moves status Issued → In-Execution.

Validation Master Plan (VMP)

Process · Cleaning · Analytical Method · CSV/GAMP 5 · IQ/OQ/PQ · ICH Q2(R1) · 21 CFR 211.68

🏅 VMP Register

🔧 IQ / OQ / PQ

🧪 Analytical Method

🧼 Cleaning Validation

🏅

Validation Lifecycle -- VMP Requirements

For each equipment/process: IQ -> OQ -> PQ. Process validation: minimum 3 consecutive PPQ batches. Cleaning validation: MACO calculation, swab/rinse method. Review every 3 years or on change.

Validation Lifecycle Register

Validation No.	System / Process / Method	Type	Protocol No.	Report No.	Acceptance Criteria	Completed Date	Status	Revalidation Due
No validation records. Add IQ/OQ/PQ for all equipment, process validations, and method validations.

🔧

Equipment Qualification -- IQ / OQ / PQ

IQ (Installation Qualification): Verify equipment is installed per manufacturer specs, utilities connected, documentation complete. OQ (Operational Qualification): Verify equipment operates within defined limits across its operating range. PQ (Performance Qualification): Verify consistent performance under actual production conditions over 3 runs.

Equipment Qualification Register

Qual. No.	Equipment ID	Equipment Name	IQ Protocol	IQ Completed	OQ Protocol	OQ Completed	PQ Protocol	PQ Completed	Next Review	Status
No equipment qualifications. Add IQ/OQ/PQ for all manufacturing and lab equipment.

🧪

Analytical Method Validation -- ICH Q2(R1)

Required parameters: Specificity, Linearity, Range, Accuracy (recovery), Precision (repeatability & reproducibility), LOD, LOQ, Robustness. New methods and any significant change require full validation. Compendial methods require verification only.

Analytical Method Validation Register

AMV No.	Method Name	Product / Analyte	Instrument	Specificity	Linearity r²	Accuracy %	Precision RSD%	LOD	LOQ	Robustness	Status
No method validations. Validate all analytical methods before use in QC testing.

🧼

Cleaning Validation -- MACO & Carryover Limits

Calculate MACO (Maximum Allowable Carryover): MACO = (Lowest daily dose of product A × Safety factor) ÷ (Highest daily dose of product B × batch size factor). Acceptance criterion: ≤10 ppm or ≤1/1000 of daily dose, whichever is lower. Visual inspection and swab/rinse sampling required.

Cleaning Validation Register

CV No.	Equipment	Product A (Previous)	Product B (Next)	MACO (mg)	Sampling Method	Swab Limit	Rinse Limit	Visual Inspection	Result	Status
No cleaning validation records. Validate cleaning procedures for all shared equipment.

Document Management System (DMS)

21 CFR Part 11 · EU GMP Chapter 4 · Schedule M Cl.14 · ICH Q10 · Version Control · Change Control · Distribution

📂 Document Repository

🔄 Document Change Control

📤 Distribution & Training Matrix

🗃 Archival & Obsolescence

🌐 External Documents

Total Documents

Active / Effective

Review Due ≤30 Days

Overdue for Review

Document Repository -- All Controlled Documents

📂

Document Control -- EU GMP Chapter 4 / Schedule M Cl.14

All GMP-critical documents must be version-controlled, reviewed periodically, and retired when superseded. Each document has a unique number, revision history, approval trail, and distribution list. Superseded copies are automatically archived.

Doc. No.	Title	Category	Department	Version	Author	Approved By	Effective Date	Review Due	Review Status	Doc. Status	Actions
No documents. Click ＋ Add Document to register controlled documents.

Document Change Control Register

🔄

Document Change Control -- ICH Q10 / Schedule M

Every change to a controlled document must be formally approved before implementation. Record what changed, why, impact assessment, and who approved. The old version is superseded and archived automatically.

Change No.	Document No.	Document Title	Change Type	Old Version	New Version	Reason for Change	Impact Assessment	Initiated By	Approved By	Effective Date	Status	Actions
No document changes. All document revisions must be logged here.

Document Distribution & Training Matrix

📤

Controlled Document Distribution -- 21 CFR 211.68

Each document issue must be tracked. Only approved, current versions may be distributed. All copies are numbered. Recipients acknowledge receipt. Training completion is recorded for each SOP/WI issued.

Distribution No.	Document No.	Title & Version	Issued To (Name)	Department	Copy No.	Issue Date	Acknowledged	Training Required	Training Completed	Training Date	Actions
No distribution records. Issue documents to personnel and record acknowledgements.

Archived & Obsolete Documents

⚠

Retention Policy -- 21 CFR 211.180 / Schedule M

Superseded documents must be retained for at least 1 year beyond the expiry of the last batch manufactured using that document version. Archived documents are stamped "OBSOLETE" and stored read-only.

Doc. No.	Title	Version	Reason Archived	Superseded By	Archive Date	Archived By	Retention Until	Storage Ref.	Actions
No archived documents. Documents are auto-archived when superseded.

External Documents Register

🌐

External Documents -- Standards, Pharmacopoeias, Regulatory Guidelines

Track all external references: Pharmacopoeia editions (IP, BP, USP), ICH guidelines, WHO guidelines, regulatory agency guidance, applicable standards (ISO, ISI). Ensure current edition is always in use.

Ext. Doc. No.	Title / Standard Name	Type	Issuing Body	Edition / Version	Year	Date Obtained	Review Due	Applicable To	Status	Actions
No external documents registered. Register pharmacopoeias, guidelines, and standards in use.

Laboratory Information Management System (LIMS)

21 CFR 211.160-194 · ISO/IEC 17025 · ICH Q2(R1) · Schedule M Cl.20 · WHO GMP Ch.6 · Sample Chain of Custody

🧫 Sample Management

📋 Work Orders

📊 Results & Approval

📄 COA Generation

📈 Stability Scheduler

🏷 Reference Standards

📖 Method Library

🗓 Instrument Booking

Total Samples

Pending Analysis

In Progress

Completed Today

Sample Login & Chain of Custody Register

🧫

Sample Login -- Chain of Custody per 21 CFR 211.160

Every sample must be logged with a unique sample ID, collection details, storage conditions, and chain of custody from collection to analysis to archive. Samples are linked to work orders for tracking.

Sample ID	Login Date & Time	Sample Type	Material / Product	Batch / Lot No.	Sampling Location	Qty Collected	Container	Storage Temp	Sampled By	Work Order	Status	Actions
No samples logged. Log each sample at collection with complete chain of custody.

Test Work Orders

📋

Work Order Management -- ISO/IEC 17025 §7.7

Each test request generates a Work Order with: sample details, tests required (auto-linked from STP), assigned analyst, target completion date, priority, and equipment required. Work Orders are the core tracking unit of LIMS.

WO No.	Created	Sample ID	Material / Product	Tests Required	Priority	STP Reference	Assigned Analyst	Target Date	% Complete	Status	Actions
No work orders. Create work orders to assign and track testing for each sample.

Test Results Entry & Two-Level Approval Workflow

📊

Results Approval Workflow -- Analyst -> Reviewer -> QC Manager

All test results go through a two-level review: Level 1 -- Analyst enters result and signs electronically. Level 2 -- Reviewer (QC Supervisor or QC Manager) reviews, verifies calculations, and approves. Rejected results trigger investigation workflow automatically.

Result ID	Date	WO No.	Sample ID	Test Parameter	Specification	Result	Unit	Pass/Fail	Analyst	Reviewer	Approval Status	Actions
No results entered. Enter test results against work orders.

Certificate of Analysis (COA) Register

📄

COA -- Certificate of Analysis per WHO / ICH Q6A

A COA is generated after all tests pass and the QC Manager signs off. COA includes: material name, batch/lot, all test parameters with specifications and results, overall Pass/Fail, analyst and QC Manager signatures, issue date. COA is used for batch release.

COA No.	Date Issued	Material / Product	Batch / Lot No.	Grade / Std.	Tests Performed	Overall Result	QC Manager	Issued To	Expiry of COA	Actions
No COAs generated. Generate a COA after all test results are approved.

Stability Study Scheduler -- Auto Pull Dates

📈

ICH Q1A(R2) Pull-Date Scheduler

Enter the study initiation date and conditions -- the system auto-calculates all pull dates: T=0, T=1M, T=3M, T=6M, T=9M, T=12M, T=18M, T=24M, T=36M. Alerts fire 14 days before each pull date. Missed pulls are flagged in red.

Study No.	Product	Batch No.	Condition	Start Date	T=0	T=3M	T=6M	T=9M	T=12M	T=24M	T=36M	Next Pull	Status	Actions
No stability schedules. Add a study to auto-calculate all ICH Q1A(R2) pull dates.

Reference Standard Management

🏷

Reference Standard Register -- Schedule M Cl.20 / WHO

Primary standards (pharmacopoeial), working standards (in-house), and impurity standards must all be tracked with: source, lot, certificate, potency/assigned content, storage conditions, expiry, and usage log. Standards are linked to analysis records.

RS Code	Name	Type	Source / Make	Lot No.	Potency / Assigned Content	Certificate No.	Received	Expiry	Storage	Opening Qty	Current Qty	Unit	Status	Actions
No reference standards registered. Add pharmacopoeial and working standards.

Analytical Method Library

📖

Method Library -- ICH Q2(R1) Analytical Method Validation

Store all validated analytical methods: HPLC assay, dissolution, disintegration, water content (KF), LOD, LOI, residue on ignition, microbial limits, etc. Each method is linked to validation data and linked to STP parameters. Methods are version-controlled.

Method No.	Method Name	Technique	Applicable To	Instrument Type	Version	Validated	Validation Ref.	STP Link	Approved By	Status	Actions
No methods registered. Add validated analytical methods linked to STPs.

Instrument Scheduling & Booking

🗓

Instrument Booking -- Prevents conflicts, ensures SST time is planned

Book QC instruments in advance. Each booking links to a work order. System checks for conflicts. Bookings that exceed calibration expiry are blocked. Analyst is notified if the instrument is under maintenance.

Booking No.	Date	Time Slot	Instrument	Instrument ID	Booked By	WO / AR No.	Purpose	Duration (hr)	Cal. Valid?	Status	Actions
No instrument bookings. Book instruments before starting analyses.

Audit Trail & Document Register

21 CFR Part 11 · Document Numbering SOP · All Records Indexed by FY 26-27 · Tamper-evident

🔐

21 CFR Part 11 Compliant Audit Trail -- Auto-Generated

Every data entry, edit, deletion, login, and approval is automatically recorded with: User ID · Role · Timestamp (local + UTC) · Action type · Old value -> New value · Mandatory reason-for-change for corrections. Records are locked and cannot be deleted.

Complete Audit Log -- All Modules

Timestamp	User	Role	Module	Action	Record ID	Old Value	New Value	Reason
Audit trail will populate automatically as you use the system. Every action is recorded here.

SOPs & Training Matrix

21 CFR 211.68 · Controlled Documents · Version Control · GMP Training Records

📄 SOP / Document Register

🎓 GMP Training Matrix

🔄 Change Control

📊 CC Dashboard

SOP / Controlled Document Register

SOP No.	Title	Department	Version	Effective Date	Review Due	Approved By	Status	Document	Actions
No SOPs registered. Add all operational, quality, and safety SOPs.

🎓

GMP Training Requirements -- Schedule M / 21 CFR 211.68

All personnel must complete GMP Basic training before working in production/QC. Annual refresher mandatory. SOP-specific training required before implementation. Training records must be maintained for the duration of employment + 3 years.

GMP Training Matrix

Employee Name	Employee ID	Role / Designation	GMP Basic	SOP Training	Annual Refresher	Next Due	Status
No training records. Add personnel and their GMP training completion status.

🔄

Change Control for SOPs / Documents

Any revision to a controlled document must go through change control: Change Request -> Impact Assessment -> QA Approval -> Implementation -> Training -> Effectiveness Review. Old versions must be archived and copies recalled per document distribution list.

SOP Change Control Register

Change No.	SOP No.	Document Title	Current Ver.	Proposed Change	Reason	Impact Assessment	QA Approval	Effective Date	Training Completed	Status
No SOP change records.

Regulatory Submissions

CDSCO · USFDA · EMA · WHO Prequalification · CTD Format · Annual GMP Returns

📋 Dossier Tracker

📜 Licences & Certificates

🗂 Annual Returns / GMP

Regulatory Dossier Tracker

Dossier No.	Product	Regulatory Authority	Submission Type	Submission Date	Reference No.	Expected Decision	Status
No regulatory submissions. Add CTD dossiers, site amendments, and prequalification submissions.

📜

Manufacturing Licences & Certificates

Maintain copies and expiry tracking for: Manufacturing Licence (Form 25/28), GMP Certificate (WHO/EU), Drug Master Files, CoPP (Certificate of Pharmaceutical Product), CEP (Certificate of Suitability), NABL/ISO Certificates, and import/export licences.

License & Certificate Register

Licence No.	Type	Issuing Authority	Scope	Issue Date	Expiry Date	Days to Expiry	Renewal Status
No licenses registered. Add all manufacturing and export licences with expiry dates.

🗂

Annual Returns & GMP Compliance Filings

Required annual filings: Form 20B (Drug Mfg. Annual Return to CDSCO), Annual Product Review (APR) per 21 CFR 211.180(e), Site Master File (SMF) update, Annual GMP Self-Inspection report, and WHO/EMA annual returns where applicable.

Annual Return / Filing Schedule

Return Type	Regulatory Authority	Financial Year	Due Date	Filed Date	Reference No.	Prepared By	Status
No annual returns filed. Set up schedule for all mandatory regulatory filings.

Customer Master

Buyer Master · GST · Drug Licences · Credit Limits · Bill-to & Ship-to · Auto-fill in Invoice

📋 Customer Master

📦 Order History

📜 Drug Licences

Total Customers

Active

DL Expiring (90d)

Blocked

Customer / Buyer Register

Code	Name / Type	GSTIN	Drug Licence	City / State	Contact	Credit	Payment Terms	Status	Actions
No customers added yet.

Customer Order History

Invoice No.	Customer	Date	Products	Qty	Value	GST	Total	Payment Status
No orders. Orders appear here when sales invoices are created in Inventory/Procurement.

📜

Drug Licence Compliance

All customers purchasing prescription drugs must hold a valid Drug Licence (Form 20B / 21B). Licences must be verified before first order and at every renewal. Selling to a customer with an expired licence is a statutory violation under Drugs & Cosmetics Act.

Customer Drug Licence Register

Customer Code	Customer Name	DL No. (Retail)	DL No. (Wholesale)	Issue Date	Expiry Date	Days to Expiry	Status
No DL records. Drug licences are imported from the Customer Master records.

Vendor Qualification & AVL

Approved Vendor List · Risk-Based Qualification · ICH Q10 · WHO QSM Guidelines

🏭 Approved Vendor List

📋 Qualification Status

🔍 Vendor Audit

🏭

Vendor Qualification Process

Step 1: Supplier questionnaire & document review. Step 2: Risk assessment (API = Cat A, excipients = Cat B, packaging = Cat C). Step 3: On-site audit for Cat A. Step 4: Qualification batches (3 lots). Step 5: Add to AVL. Annual re-evaluation required.

Approved Vendor List (AVL)

Vendor Code	Vendor Name	Material	Category	GST No.	PAN No.	Country	Last Audit	Score	GMP Cert Expiry	Next Audit Due	Status	Actions
No vendors qualified yet. Add all RM, PM, and service suppliers to the AVL.

Vendor Qualification Records

Vendor Code	Vendor Name	Material Category	Questionnaire	Document Review	Risk Score	Site Audit	Qual. Batches	AVL Status	Next Review
No qualification records. Begin qualification process for prospective vendors.

🔍

Vendor Audit Programme

Category A (API) vendors: annual on-site audit. Category B (excipients): biennial audit or questionnaire. Category C (packaging): triennial review. Audit findings classified as Critical, Major, Minor. CAPAs must be closed before re-approval.

Vendor Audit Records

Audit No.	Vendor Code	Vendor Name	Audit Date	Auditor	Critical Obs.	Major Obs.	Minor Obs.	Overall Score	CAPA Status	Next Audit Due	Result
No vendor audit records.

Procurement, GST & Sales

GST-Compliant Purchases · Purchase Categories · Tax Invoice · IRN · E-Invoicing · Vendor Drug Licences

₹0

RM Purchase Value (MTD)

₹0

FG Sales Value (MTD)

Open POs

₹0

GST Payable (Output)

₹0

ITC Available (Input)

Reorder Alerts

Indents

Quotations

Purchase Orders

Purchase Register

Sales / Tax Invoices

GST Summary

Vendor Drug Licences

Indent Register (Purchase Requisitions)

Departments raise indents to request materials. After 2-level approval (HOD → Plant Head), approved indents can be converted to Purchase Orders. Converted indents show a link to their PO.

Indent No.	Indent Date	Department	Required By	Items	Approx Value (₹)	Priority	Workflow Stage	PO Status	Actions
No indents raised yet.

Quotation Register (Vendor Quotes)

Quotations are vendor quotes against approved indents. Use the comparison matrix to evaluate side-by-side and select the winner. Selected quotations can be promoted to PO. GMP best practice: collect 3 quotations minimum before raising a PO above cost threshold.

Quote No.	Quote Date	For Indent	Vendor	Items	Grand Total (₹)	Lead Time	Valid Until	Status	Actions
No quotations recorded yet.

Purchase Order Register

PO No.	Purchase Category	Material / Item	Vendor	Qty	Unit	Rate (₹)	GST %	Total (₹)	PO Date	Expected	Status	Actions
No purchase orders yet.

Purchase Register (GST-wise)

Entry No.	Entry Date	Invoice No.	Invoice Date	Vendor	Vendor GSTIN	Taxable Value (₹)	GST %	Total (₹)	Actions
No purchase records. Record purchases to build GST register.

Sales Register / Tax Invoices

Invoice No.	Date	Customer	Customer GSTIN	Product	Batch No.	HSN	Taxable (₹)	GST %	IGST (₹)	CGST (₹)	SGST (₹)	Total (₹)	IRN	Status	Actions
No invoices raised yet.

Output GST (Sales)

GST %	Taxable (₹)	IGST (₹)	CGST (₹)	SGST (₹)	Total GST (₹)
No sales recorded.

Input Tax Credit (Purchases)

Category	Taxable (₹)	IGST (₹)	CGST (₹)	SGST (₹)	ITC (₹)
No purchases recorded.

GST Net Liability Summary

₹0

Net IGST

₹0

Net CGST

₹0

Net SGST

₹0

Net GST Payable

Vendor Drug Licence Register Track all vendor DL-20B, DL-21B, FSSAI, GMP licences with validity & scan copies

Vendor Code	Vendor Name	GSTIN	DL-20B No.	DL-20B Expiry	DL-21B No.	DL-21B Expiry	GMP Cert Expiry	Drug Lic Expiry	Status	Docs
No vendor licence data. Add vendors with drug licence details in Vendor Qualification module.

Instruments & Calibration

21 CFR 211.68 / 211.160(b)(4) · Sch M Cl.4.5 · ISO 17025 Traceability · Separate from Equipment Qualification

🌡️ Instrument Register

📐 Calibration Records

📋 Calibration Procedures

Instrument Register

Instrument No.	Name	Category	Make/Model	Serial No.	Location	Frequency	Status	Actions
No instruments registered. Click + Add Instrument.

🌡️

Instrument Calibration — 21 CFR 211.68 / 211.160(b)(4)

Every calibration event is a permanent, hash-chained record — corrections are new entries, never edits. QA review required before an instrument returns to service after a Fail result.

Calibration Records

Cal. No.	Instrument	Cal. Date	Due Date	Type	Standard Used	Result	Performed By	QA Status
No calibration records yet.

📋

Calibration Procedures — 21 CFR 211.68 / Sch M Cl.4.5

Define the step-by-step calibration method per instrument category. Every instrument of that category follows the defined procedure; steps appear on the calibration record for reference.

Procedure Templates (by Category)

Category	Steps	First Step	Actions
No procedures defined yet.

Equipment Management

IQ/OQ/PQ · Preventive Maintenance · 21 CFR 211.68 · Schedule M Clause 12 · Qualification Programme

⚙ Equipment Register

📏 Qualification Programme

🔧 Preventive Maintenance

🚨 Breakdown Log

Equipment Register

Equip. ID	Description	Make / Model	Serial No.	Location / Room	Capacity	IQ/OQ/PQ Status	Last Qualification	Next Qualification	Last PM	Next PM	Current Status	Actions
No equipment registered. Add all manufacturing, laboratory, and utility equipment.

🔧

Preventive Maintenance Programme

PM schedules are based on manufacturer recommendations, usage frequency, and GMP requirements. PM must be completed on schedule; overdue PM puts equipment in "maintenance required" status and production use must cease until cleared.

PM Checklist Records (Engineering)

Record No.	PM Date	Equipment ID	Equipment Name	Schedule Ref	Result	Performed By	Verified By	Next PM Due	Register
Open this tab to read the PM Checklist Records.

Breakdown & Corrective Maintenance Log

Work Order	Equipment ID	Date Reported	Nature of Breakdown	Production Impact?	Batches Affected	Technician	Root Cause	Action Taken	Date Resolved	Downtime (hrs)
No breakdown records.

👥 User Management

21 CFR Part 11 · RBAC · Role-Based Access Control · 2FA Enrollment

✅ Session 53D · v8.4.3 · Login Fix Complete

Users: 0 / -- licensed

👥 Registered Users

📋 User Activity Logs

🔍 User Audit (Detailed)

Total Users

Active

Locked/Inactive

2FA Enrolled

Registered System Users

User ID	Name	Role	Department	Email	2FA	Status	Last Login	Actions
No users yet -- click Create User to add first user

📋 User Activity Log -- Audit Trail by User

#	Date & Time	User ID	User Name	Role	Module	Action	Record / Detail	IP Address	Session ID
Select a user filter or view all audit logs.

🔍 User Audit (Detailed) -- Per-Field Diff & Server Rejections

Local source: -- entries from DB.users_audit (per-field diffs from User Management)
Server source: -- entries from /api/users-audit (validation rejections + sync events)

Date & Time	Actor	User ID	Event	Source	Details
Loading audit entries...

📥 Data Import -- Excel Templates v4

17 data types · Upload CSV (saved from Excel) · Preview before confirm · Append-only · 21 CFR Part 11 Audit Logged

⬇ Download Template (v4)

📥

How to Import from PharmaNetra(TM) Data Templates v4.xlsx

Step 1: Fill the Excel template sheet with your data (download PharmaNetra(TM)_Data_Templates_v4.xlsx).
Step 2: In Excel, open the sheet -> File -> Save As -> CSV UTF-8 (Comma delimited) -> save one sheet at a time.
Step 3: Click the matching Upload CSV button below, review the preview, then click Confirm Import.
Note: Import appends to existing data -- it does not replace. Each sheet imports independently. Mandatory columns (★) must be filled.

🧪 Sheet 01 -- Batch Production

Maps to: Production & BMR · Mandatory: Batch No, Product

📄 Upload Sheet 01 CSV

No file selected

📦 Sheet 02 -- Raw Material Inventory

Maps to: Warehouse -> Raw Materials · Mandatory: RM Code, Name, Lot, Expiry

📄 Upload Sheet 02 CSV

No file selected

🏭 Sheet 03 -- Vendor AVL

Maps to: Vendor Qualification · Mandatory: Vendor Code, Name

📄 Upload Sheet 03 CSV

No file selected

⚙️ Sheet 04 -- Equipment & Calibration

Maps to: Equipment Management · Mandatory: Equipment ID, Description

📄 Upload Sheet 04 CSV

No file selected

📋 Sheet 05 -- SOP Register

Maps to: SOPs & Training · Mandatory: SOP No, Title

📄 Upload Sheet 05 CSV

No file selected

⚠ Sheet 06 -- Deviations & CAPA

Maps to: Deviations & CAPA · Mandatory: Dev No, Description

📄 Upload Sheet 06 CSV

No file selected

🔬 Sheet 07 -- QC Analytical Results

Maps to: QC Lab -> RM Testing · Mandatory: AR No, Material

📄 Upload Sheet 07 CSV

No file selected

📉 Sheet 08 -- OOS / OOT Investigations

Maps to: OOS/OOT Module · Mandatory: OOS No, Product, Result

📄 Upload Sheet 08 CSV

No file selected

🧪 Sheet 09 -- Stability Studies

Maps to: Stability Studies · Mandatory: Study No, Product, Batch No

📄 Upload Sheet 09 CSV

No file selected

💬 Sheet 10 -- Product Complaints

Maps to: Product Complaints · Mandatory: Complaint No, Product, Description

📄 Upload Sheet 10 CSV

No file selected

✅ Sheet 11 -- Validation Records

Maps to: Validation Master Plan · Mandatory: Val No, System

📄 Upload Sheet 11 CSV

No file selected

📊 Sheet 12 -- IPQC Results

Maps to: IPQA/IPQC · Mandatory: Batch No, Parameter

📄 Upload Sheet 12 CSV

No file selected

🌬 Sheet 13 -- Environmental Monitoring

Maps to: Production -> Env. Monitoring · Mandatory: Date, Location

📄 Upload Sheet 13 CSV

No file selected

👥 Sheet 14 -- Customer Master

Maps to: Customer Master · Mandatory: Customer Code, Name

📄 Upload Sheet 14 CSV

No file selected

✅ Sheet 15 -- Finished Goods Inventory

Maps to: Warehouse -> Finished Goods · Mandatory: Product, Batch No, Qty

📄 Upload Sheet 15 CSV

No file selected

📦 Sheet 16 -- Packaging Materials

Maps to: Warehouse -> Packaging Materials · Mandatory: PM Code, Description

📄 Upload Sheet 16 CSV

No file selected

📋 Sheet 17 -- BMR Templates

Maps to: Production -> BMR Library · Mandatory: BMR Ref No, Product, Approved By

📄 Upload Sheet 17 CSV

No file selected

🌡️ Sheet 18 -- Instrument Master

Maps to: Instrument Master (cal_instruments, NEW) · Calibration records are added via the e-signed Calibration module · Mandatory: Instrument Name

📄 Upload Sheet 18 CSV

No file selected

🧪 Sheet 19 -- API Master

Maps to: API Master · Mandatory: Code, Name, INN, Pharmacopoeia

📄 Upload Sheet 19 CSV

No file selected

⚗️ Sheet 20 -- Excipient Master

Maps to: Excipient Master · Mandatory: Code, Name, Pharmacopoeia

📄 Upload Sheet 20 CSV

No file selected

📦 Sheet 21 -- PM (Packaging) Master

Maps to: PM Master catalog · Mandatory: Code, Name

📄 Upload Sheet 21 CSV

No file selected

💊 Sheet 22 -- Finished Product Master

Maps to: Product Master · Mandatory: Code, Name

📄 Upload Sheet 22 CSV

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CTD Module	Content Description	Attach Document
Module 1	Administrative -- Application forms, product information, labelling, prescribing information	📄Attach PDF
Module 2	Summaries -- Quality Overall Summary (QOS), Non-clinical, Clinical Summary	📄Attach PDF
Module 3	Quality -- Drug substance (API), Drug product, Excipients, Container closure system	📄Attach PDF
Module 4	Non-clinical -- Pharmacology, Pharmacokinetics, Toxicology study reports	📄Attach PDF
Module 5	Clinical -- Clinical study reports, Bioequivalence, Clinical pharmacology	📄Attach PDF
Site Master File	Site Master File / GMP Certificate / Manufacturing Licence	📄Attach PDF
Bioequivalence	BE Study Report / Comparative Dissolution Data	📄Attach PDF
Deficiency Reply	Response to Authority Queries / Deficiency Letter	📄Attach PDF
Approval Docs	Approval Letter / Marketing Authorisation / Import Licence	📄Attach PDF
Other	Any other supporting documents not covered above	📄Attach PDF

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