FDA 21 CFR PART 11 & GXP COMPLIANCE
Quality Software Built for Pharma — eQMS, eBMR, LIMS, and DMS
Buy the system your site actually needs. QA Stack delivers purpose-built pharma software for deviations and CAPA, electronic batch records, QC laboratory management, and SOP document control — each deployable on its own, with the option to connect as your operation grows.
Operational Efficiency
Eliminate document backlogs and paper records in your plant.
Watch our guide on automating deviation logs, SOP reviews, and batch record sign-offs to stay inspection-ready.
Modular Compliance
Modular GxP Software. Deploy What You Need.
Select and deploy individual modules—like eQMS, eBMR, LIMS, or DMS—or connect them to run a synchronized, validation-ready operation. Replace paper logs, spreadsheet tracking, and isolated database tools without purchasing unnecessary software.
Deviations · CAPA · Audits
Batch Records · Dispensing
SOPs · Approvals · Versioning
Material Testing · Specs
Qualifications · SOP Training
APQRs · Trends · KPIs
Product Architecture
Built for Quality & Production Teams
Automate deviation logs & CAPAs.
Track NCRs, deviations, CAPAs, and supplier audits in a validation-ready queue. Automated workflow routing ensures fast, error-free closures.
Eliminate paper batch records.
Digitize your Master Batch Records (MBRs). Verify line clearances, capture dispensing weights, track raw materials, and record step yields in real time.
Secure SOP lifecycles & version control.
Author, review, and approve SOPs and validation protocols with electronic signatures. Track training records and ensure only current versions are active.
Traceability & Audits
Connected workflows. Immutable logs.
Every signature, step verification, and approval remains permanently logged in your secure audit trail. Audit readiness is built-in.
Compliance & Control
Built for WHO-GMP & FDA audits.
QA Stack provides the absolute operational controls required for regulated pharmaceutical manufacturing — 21 CFR Part 11, EU GMP Annex 11, GAMP 5.
Whitepapers & Compliance Guides
Regulatory Briefings & Research
Guides on FDA audit readiness, GxP validation strategies, and electronic record migration.
Frequently Asked Questions
Compliance & Implementation Answers
Is QA Stack 21 CFR Part 11 compliant?
Yes. QA Stack includes secure login, role-based access control, electronic signature workflows, and dynamic audit trails, fulfilling all electronic record and signature requirements.
Can it operate as a complete platform or separate modules?
You can deploy modules individually (e.g. eQMS, eBMR, DMS, LIMS) or run a unified configuration based on your quality and production requirements.
Does the software support GAMP 5 validation?
Yes. The platform is designed following GAMP 5 Category 4 principles, and we provide standard validation packages (IQ, OQ, PQ templates).
Can we migrate paper SOPs and logs easily?
Yes. We offer automated spreadsheet/PDF imports and a guided setup process to convert your current paper records into electronic workflows.
How are self-inspections and audit trails handled?
Every record change, dispensing weight, and approval is stamped with user details, timestamps, and justification. Audit logs can be filtered and exported instantly during inspections.
Ensure validation readiness in your quality unit.
Centralize deviations, SOP approvals, dispensing logs, and audit trails.