What the customer owns and what the product provides
docs365.ai is a tool. Your QA team owns:
- Validation of the product as installed and operated in your environment (IQ, OQ, PQ or the equivalent under your CSV procedures).
- The specific SOP content, the specific review cadences, the specific change-control procedures.
- Periodic data-integrity reviews, internal-audit programs, and responses to inspection findings.
- The GxP interpretation of every control applied to documents.
The product provides capabilities that make those activities cheaper and more defensible. It does not replace them.
Pharma-specific FAQ
Is the product pre-validated for 21 CFR Part 11? No. We do not ship a pre-validated installation. Validation is conducted by your QA or CSV team for the specific installation and intended use.
Can I use this alongside an existing validated QMS platform? Yes — and many customers do during a transition. The product can cover document-control scope while a specialist QMS continues to handle other QMS activities. For customers evaluating a full QMS-vs-DMS decision, see intranet.ai vs. MasterControl →.
Does it support ICH-GCP, GMP, GLP documents specifically? The lifecycle is regulation-agnostic: templates, approval, versioning, publication, expiration, archive apply to any controlled document. Specific fit with ICH and GxP expectations is verified by your QA team against your processes.
What about submissions in eCTD format? The product manages the sponsor's internal documents (SOPs, protocols, change-control records) that go into submissions. eCTD assembly and submission uses specialized publishing tools. The two are complementary.
Does it integrate with our LIMS / ERP / training-management system? Not directly — it's a document-management layer on Microsoft 365. Document-level integration (embedded links, references to training records, metadata synchronization) is typically handled via Power Automate or custom work at project scope.
Is the DocuSign integration PAdES-only? Yes — PAdES simple and PAdES advanced e-signature. CAdES, qualified electronic signature (QES), and non-PAdES formats are not supported. Customers who require CAdES or QES for specific documents maintain a parallel signature workflow for those documents.
Pair with FDA 21 CFR Part 11 page for the full compliance picture
The compliance specifics — unique authentication, access control, audit trail, version control, electronic signatures — are mapped control-by-control on the FDA 21 CFR Part 11 page →.
For multi-regulated organizations (pharma + ISO 9001 + GDPR), the unified approach is described in the Microsoft 365 as a compliance platform guide →.
Related
