QA Stack
The operating system for modern pharmaceutical manufacturing
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What Exactly Is QA Stack?

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isn't a traditional ERP.

It isn't just a QMS.

It isn't just an eBMR.

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.

How do you see the future of operational software evolving?

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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.

How does the eBMR handle connection losses on the shop floor?+

The QA Stack eBMR uses an offline-first execution architecture. If connectivity to the cloud is lost during active batch processing, local browser storage caches executed steps, IPC entries, and local user signatures. Upon reconnecting, the edge service validates data checksums and syncs cached records back to the central database.

Can we connect QA Stack directly to weighing balances and PLCs?+

Yes. We utilize standard industrial edge gateways supporting OPC-UA, MQTT, and Modbus RTU/TCP protocols. This allows our system to pull raw weight data directly from scales during excipient dispensing, and capture critical process parameters (CPPs) directly from PLC blenders, eliminating manual data transcription.

What is Review by Exception (RBE) and how does it speed up release?+

Traditional batch release requires QA to review every page of a paper record. QA Stack eBMR automatically tracks process variables against recipes in real time. If all steps completed within limits and zero deviations occurred, the RBE dashboard flags the batch as "green," allowing QA to sign off immediately. If deviations occurred, the system displays only those exceptions for targeted review.

How is data audit trailing handled during corrections?+

If a signed step requires correction, QA must initiate the Step Unlock flow. The system prompts for credentials and a reason code, unlocks the step, and logs a correction event. When the operator edits and re-saves the data, both the old value and the new value are preserved in the immutable SQL audit trail, preventing data deletion.

21 CFR Part 11WHO-GMPCDSCOEU Annex 11

Each module — eQMS, eBMR, LIMS, and DMS — can be deployed standalone or connected as your operation grows. Built for 21 CFR Part 11, WHO-GMP, CDSCO Schedule M, and EU Annex 11.

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eBMR Software for Pharma | Replace Paper Batch Records Electronically | QA Stack