Protokol implements electronic signatures that meet the technical requirements of 21 CFR Part 11 — the FDA regulation governing electronic records and signatures in pharmaceutical manufacturing.
Each signature captures a unique identity verification, an acknowledgement statement confirming the signer's understanding and intent, a timestamp, and a link to the exact document version signed. Signatures are cryptographically linked to the document and cannot be transferred or reused.
The Requirements Traceability Matrix (RTM) is one of the most time-consuming documents in a C&Q project, requiring manual cross-referencing between URS requirements and test protocols. Protokol eliminates this with AI-powered auto-linking.
Upload your URS and test protocols. Protokol AI reads both, identifies requirement references, and populates the RTM automatically — linking each requirement to the test cases that verify it. Gaps are flagged immediately. Run it on demand or schedule a nightly refresh.
The Knowledge Vault is a project-level library where you upload SOPs, equipment manuals, P&IDs, URS documents, and historical protocols. Protokol indexes every document using Voyage AI embeddings, making the content available for AI retrieval during document generation.
When the AI writes a section, it searches the vault for relevant content, pulls the right passages, and cites them. This means every generated section is grounded in your specific equipment and process — not generic boilerplate.
Once a document is reviewed and approved, export it in the format your customer or DMS requires. Protokol generates professional Word (.docx) files with correct heading styles, numbered sections, tables, and formatted acceptance criteria — ready to drop into any Document Management System.
PDF export is handled via Chromium-based rendering for pixel-perfect output. Both formats carry the document metadata, revision number, and approval status in the header/footer.
Protokol maintains a complete, append-only audit log of every action taken on every document in the platform. This log cannot be modified, deleted, or backdated by any user — including administrators.
At the time of approval, the full document content is hashed (SHA-256) and the hash is stored in the audit log alongside the approver's identity and timestamp. This provides cryptographic proof that the approved content has not been altered since approval.
We'll walk through any or all of these features with your specific document types and workflow in mind.
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