Can we use this for GxP-regulated workflows?

What GxP “workflows” covers

GxP is a family of expectations rather than a single rulebook — GMP (manufacturing), GLP (laboratory), GCP (clinical), all with intersecting documentation requirements. The common thread: controlled documentation with specific audit-trail, signature, and validation expectations.

Where we fit

Customers use our product for the document-governance layer of their GxP programs:

• SOPs in GxP scope — created from controlled templates, approved through sequential flows with QA as fixed approver, published as immutable PDFs, audit-log tracked, version-controlled.
• Documented information supporting GxP operations — policies, work instructions, training records, calibration records — all under the same active-lifecycle governance.
• PAdES signatures on regulatory submissions — DocuSign advanced PAdES for customer-to-regulator signed documents where cryptographic binding is expected.

Italfarmaco is the canonical example — roughly 2,000 SOPs across a multi-site pharma operation, all under our governance, with their QA team owning the 21 CFR Part 11 validation posture. See their case study.

Where we don’t fit

Fully validated QMS platforms with vendor-supplied validation documentation (IQ/OQ/PQ scripts, traceability matrices, vendor-side change control) are the domain of MasterControl and equivalents. Use cases:

• Pharmaceutical manufacturing where the DMS platform itself is in validation scope
• Medical-device design controls under 21 CFR 820
• Clinical-trial document management where the DMS is qualified per regulatory expectations

For these, specialized validated QMS platforms remain the better fit. Many pharma customers run a hybrid: MasterControl for validated GxP scope, intranet.ai for the broader corporate/operational documentation that sits alongside.

See SharePoint vs AvePoint vs MasterControl buying guide for the full comparison.