Manual data collection
Analysts spend months extracting batch, lab and deviation data by hand from half a dozen systems.
Annual Product Quality Review (APQR)
Automate Annual Product Quality Reviews by consolidating quality, manufacturing, laboratory and deviation data into a centralized platform that generates regulator-ready reports, identifies trends and supports continuous process improvement.
- 21 CFR 211.180(e)
- EU GMP Chapter 1
- ICH Q10
- 21 CFR Part 11
APQR · Review period 2025–26
Product quality intelligence
Batches reviewed
248
Quality index
96.4
Deviations
17
Open CAPA
4
Cpk trend · critical parameters
Complaints0.8 per millionStable
Stability6 studies on trendNo adverse
Annual reportSection 7 of 12In review
The annual review is still a spreadsheet project
Most quality teams spend more time collecting the data than analysing it — and the review is late, manual and hard to defend.
Multiple Excel reports
Spreadsheets are copied, versioned and emailed until nobody knows which file is the approved one.
Disconnected systems
Quality, laboratory, manufacturing and ERP data live apart, with no common product or batch key.
Time-consuming annual reviews
Reviews start late, run for weeks and are still being compiled when the due date arrives.
Limited trend analysis
Reports describe what happened without the statistical trending that would have predicted it.
Audit & regulatory pressure
Inspectors challenge the completeness, timeliness and traceability of the review data.
Traditional APQR process versus Nexgensis digital APQR
The same regulatory obligation, produced from live source data instead of months of extraction, formatting and reconciliation.
Traditional APQR process
- Data extracted manually from each system
- Data scattered across spreadsheets and folders
- Trends drawn by hand at the end of the year
- Cp/Cpk calculated offline, if at all
- Reports assembled and formatted manually
- Each plant reviews in its own format
- Review cycles measured in months
- A compliance document filed and forgotten
Nexgensis digital APQR
- Automated data collection from every integrated system
- Centralised quality data with one product and batch key
- Automated trend analysis refreshed continuously
- Statistical process monitoring built into the platform
- Regulatory report generation from approved templates
- Cross-plant visibility on a common standard
- Faster review cycles with routed electronic approval
- Better decision making from live quality intelligence
From source data to the approved regulatory report
Data is collected automatically from every integrated system, validated, trended and transformed into a comprehensive APQR report — with actions carried into the next review period.
01
Collect Data
Batch, laboratory, deviation, complaint and change data pulled automatically.
02
Validate Data
Completeness, range and reconciliation checks before anything is trended.
03
Aggregate Information
Records consolidated by product, strength, site and review period.
04
Trend Analysis
Statistical trending, capability and year-on-year comparison generated.
05
Quality Review
QA reviews findings, adds assessment and conclusions in the system.
06
Management Approval
Routed electronic approval with Part 11 signatures and comments.
07
Regulatory Report
The final APQR/PQR report issued in a controlled, exportable format.
08
Continuous Improvement
Actions raised as CAPA and tracked into the next review period.
Every review section, assembled automatically
Twelve data sources, one product review
Every figure in the report is pulled from its system of record and stays linked to it, so any number can be traced back to the batch, result or event behind it.
eQMS
Deviations, CAPA, complaints, change control and audits.
LIMS
Release, in-process and stability laboratory results.
eBMR
Batch execution, yield, in-process checks and exceptions.
DMS
Specifications, SOPs and controlled report templates.
ERP
Batch genealogy, dispatch, returns and material master data.
MES
Process parameters and equipment performance data.
OPS IQ APQR
Quality data core
Supplier Quality
Vendor performance, rejections and qualification status.
Stability Studies
Ongoing and accelerated stability data by condition.
Complaint Management
Market complaints, categories and confirmed defects.
CAPA
Corrective and preventive actions with effectiveness checks.
Change Control
Product, process and equipment changes in the period.
Laboratory Results
Analytical data, OOS and OOT investigations.
Statistics that turn a report into a decision
Capability, control charts and year-on-year comparison calculated on the same data set that produces the regulatory report.
Process capability · Product A, 10 mg
Assay (%)
CapableCp 1.62
Cpk 1.48
Dissolution (%)
CapableCp 1.44
Cpk 1.31
Hardness (N)
MarginalCp 1.18
Cpk 1.02
Weight variation
CapableCp 1.87
Cpk 1.74
Product performance trends
Critical quality attributes trended across the review period.
Batch yield trends
Yield and reconciliation compared batch to batch and year to year.
Deviation trends
Recurrence by category, area, equipment and root cause.
Complaint trends
Complaint rate normalised per million units dispatched.
OOS / OOT trends
Laboratory result excursions with investigation outcomes.
Cp / Cpk analysis
Capability indices per parameter with specification limits applied.
Process capability
Capability status flagged as capable, marginal or at risk.
Statistical process control
Control charts with rule violations highlighted automatically.
Annual performance comparison
This period against the previous periods, product by product.
Regulator-ready reports, generated not written
Approved templates populate themselves from live data; QA adds the assessment and the report is signed and issued under change control.
Report generation workflow
1. Select product & period
2. Auto-populate sections
3. Review trends
4. Add QA assessment
5. Route for approval
6. Issue controlled report
Automated APQR reports
The full review generated from live data, not retyped from spreadsheets.
Product-wise reports
One report per product, strength, pack and market as required.
Site-wise reports
Site and cross-site consolidations on a single corporate standard.
Regulatory-ready documents
Formatted to satisfy 21 CFR 211.180(e) and EU GMP Chapter 1 PQR.
Executive summary
Conclusions, product disposition and recommendations up front.
Quality trend reports
Standalone trend packs for management and quality council review.
PDF & Excel export
Controlled PDF for issue plus Excel data extracts for analysis.
Electronic approval workflow
Author, review and approve with Part 11 electronic signatures.
Built for inspections and management reviews
Reviews are completed on schedule, every figure is traceable to its source record, and the evidence is produced during the inspection itself.
FDA 21 CFR Part 11
Electronic records and signatures with secure, computer-generated audit trails.
EU GMP Annex 11
Computerised system controls, access management and periodic review.
ICH Q10
Product quality review as part of the pharmaceutical quality system.
WHO GMP
Annual product review expectations for products and starting materials.
Schedule M
Indian GMP product quality review and record retention requirements.
GAMP 5
Risk-based validation with documented lifecycle deliverables per release.
ALCOA+
Attributable, legible, contemporaneous, original, accurate and complete data.
Electronic Signatures
Meaning-bound signatures on authoring, review and approval steps.
Audit Trails
Every data pull, recalculation and approval permanently recorded.
Data Integrity
Source-linked figures with no manual retyping between systems.
Quality intelligence, all year round
The same data that produces the annual review drives live dashboards for quality councils, site leadership and corporate QA.
Annual quality index · rolling 12 months
0
Quality index
0%
Right first time
0
Products reviewed
0%
Reviews on time
Product quality score
A weighted index combining deviations, complaints, OOS and capability.
Batch performance
Right-first-time, yield and rejection rate by product and line.
Cpk trends
Capability trended over time for every critical parameter.
Complaint summary
Complaint volume, category mix and confirmation rate.
CAPA status
Open, overdue and effectiveness-pending actions by product.
Deviation analysis
Deviation counts by classification, area and recurrence.
Stability overview
Studies in progress, results due and any adverse trends.
Annual quality index
A single comparable score by product, site and review period.
Measurable quality outcomes
0%
Faster APQR preparation
0%
Automated data collection
0%
Less manual reporting effort
0%
Faster management reviews
Improved quality visibility
Product performance visible all year, not reconstructed at year end.
Better trend identification
Statistical trending surfaces drift before it becomes a deviation.
Improved regulatory compliance
Reviews completed on time with traceable, source-linked data.
Centralised quality intelligence
One version of quality truth across products, sites and periods.
Trusted across regulated industries
Pharmaceuticals
Biotechnology
Medical Devices
Nutraceuticals
Food & Beverage
Chemicals
Why quality teams choose OPS IQ APQR
Unified OPS IQ platform
APQR reads directly from eQMS, LIMS, eBMR, DMS and eLogs — no exports.
Automated data aggregation
Source-linked figures assembled by product, strength, site and period.
Enterprise analytics
Trending, capability and SPC across every product and every plant.
Regulatory compliance
21 CFR 211.180(e), EU GMP Chapter 1, ICH Q10 and Part 11 aligned.
Cross-plant reporting
Corporate standard templates with governed site-level variations.
Cloud or on-premise
Deploy in our validated cloud or inside your own data centre.
Scalable architecture
From a handful of products to a global portfolio across every site.
Intelligent quality insights
Pattern detection that highlights what deserves attention first.
A predictable path to automated reviews
A first product family typically goes live in 10 to 14 weeks, including data mapping, connectors, templates and validation.
Phase 1
Discovery
Product scope, review template review and data source mapping.
Phase 2
Integration
Connectors to eQMS, LIMS, eBMR, ERP, MES and stability systems.
Phase 3
Configuration
Report templates, trending rules, capability limits and approval routes.
Phase 4
Validation
IQ/OQ/PQ execution with GAMP 5 aligned documentation.
Phase 5
Go-live
First review cycle run in parallel, then spreadsheets retired.
APQR questions, answered
An Annual Product Quality Review is a periodic, documented evaluation of every licensed product covering batch performance, laboratory results, deviations, complaints, CAPA, change control, stability and supplier performance. It verifies process consistency, confirms the suitability of specifications and identifies improvement opportunities.
Transform annual product reviews into continuous quality intelligence
Automate Annual Product Quality Reviews with Nexgensis APQR to eliminate manual reporting, accelerate regulatory reviews, identify trends earlier and drive continuous product quality improvement.
- 45-minute working session on one of your own product reviews
- Data source mapping and trending walkthrough
- Validation, integration and report template review