Industries · Pharma
Pharma document management on SharePoint Online
SOPs, training records, change-control documents — governed end-to-end inside your Microsoft 365 tenant.
By Giuseppe Marchi · Microsoft SharePoint MVP · intranet.ai
Pharma operations run on procedures. SOPs define every repeatable process, change-control documents manage every deviation, training records prove every person is qualified for every task, batch records capture what actually happened on every production run. The quality of the documents is the quality of the operation.
This product provides document-governance capabilities — template-driven creation, sequential approval, versioning, audit log, PAdES e-signature via DocuSign — that pharma customers can use in their GxP and 21 CFR Part 11 compliance programs. Validation and regulatory responsibility remain with the customer's QA team.
Logo
Italfarmaco
Customer story
"We centralized every active procedure across our departments into one governed repository with a structured approval flow — while our QA team owns the 21 CFR Part 11 validation posture."
— QA Operations — Italfarmaco
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 docs365.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.
FDA 21 CFR Part 11 — section-level capability mapping
21 CFR Part 11 divides requirements into three practical areas. Here is how the product's capabilities map to each section:
§11.10 — Controls for closed systems
| §11.10 sub-section | Requirement | Product capability |
|---|---|---|
| §11.10(a) | Validation of systems to ensure accuracy, reliability, consistent intended performance | Customer CSV program; product provides IQ/OQ documentation artifacts |
| §11.10(b) | Ability to generate accurate and complete copies of records in human-readable and electronic form | Export to PDF/A; SharePoint record export; audit-trail printout |
| §11.10(c) | Protection of records to enable accurate and ready retrieval throughout the record retention period | SharePoint retention policies; in-place hold; archive flag per document |
| §11.10(d) | Limiting system access to authorized individuals | Azure AD-based access control; permission sets per document type and lifecycle stage |
| §11.10(e) | Use of secure, computer-generated, time-stamped audit trails | Immutable SharePoint audit log: who viewed, who edited, who approved, with UTC timestamp |
| §11.10(f) | Use of operational system checks to enforce permitted sequencing of steps and events | Configurable approval workflow: sequential or parallel, with mandatory steps and role gates |
| §11.10(g) | Use of authority checks to ensure only authorized individuals can use the system, electronically sign, or alter a record | Role-based signature authority; DocuSign PAdES; per-step approver designation |
| §11.10(h) | Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input | Microsoft 365 conditional access policies (device compliance, location, MFA) |
| §11.10(i) | Determination that persons who develop, maintain, or use electronic record/signature systems have the education, training, and experience to perform their assigned tasks | Training record linkage in document metadata; acknowledgement workflow per publication |
| §11.10(j) | Establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures | Policy enforcement through workflow; signature meaning captured in DocuSign envelope |
| §11.10(k) | Use of appropriate controls over systems documentation including adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance | Controlled-document lifecycle applied to system SOPs; version control; distribution log |
§11.50 — Signature manifestations (Subpart C)
| §11.50 requirement | Product capability |
|---|---|
| Signed electronic records must display the printed name of the signer | DocuSign PAdES certificate includes signer identity; name rendered in the signed PDF |
| Date and time of signing | UTC timestamp embedded in PAdES signature and in the document audit trail |
| Meaning of the signature (e.g., reviewed, approved, authored) | Configurable signature meaning per workflow step; captured in the DocuSign envelope and stored in document metadata |
§11.70 — Signature/record linking
| §11.70 requirement | Product capability |
|---|---|
| Electronic signatures must be linked to their respective electronic records | PAdES signature is embedded in the PDF document; DocuSign transaction ID stored in SharePoint metadata, creating a tamper-evident link between the signed record and the signature event |
| Alteration of the record or signature must be detectable | PDF/A integrity verification; SharePoint versioning captures any post-signature modification; audit trail records all events |
For a complete control-by-control deep dive including §11.100 (identity proofing) and §11.200 (biometric vs. non-biometric), see the FDA 21 CFR Part 11 compliance page →.
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 →.
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