ValiDoc is our Computer System Validation documentation platform for pharma manufacturers, CDMOs, medical-device makers and the consultancies that carry validation documentation for them. It is live at validoc.byteflowtech.in, and every document format in it was built against real client annexures with a practising CSV consultant reviewing the output.
The problem it removes. Validation packs still get written in Word, versioned by filename, and approved on paper. The pack is only as good as the discipline of whoever assembled it — and an inspector's first question is usually about the audit trail, not the prose.
What ValiDoc does instead. 49 document types across the seven lifecycle phases — planning and reporting (VP, VS, VSR), requirements (URS, FS, DS, CS, IQR), risk (RA, FRA, CSA, FMEA, RTM), testing (IQ, OQ, PQ, UAT, TSR, defect log), vendor assessment (VAQ, SAC, SER), SOPs (change control, backup/restore, access management, incident, disaster recovery, periodic review) and operational (data integrity, security, business continuity, retention). Sections are data, not a template dump: they arrive pre-filled, the author edits or excludes what does not apply, and Preview shows the document exactly as it will issue.
Determinations are computed, never typed. One Yes across the GxP questions makes a system GxP relevant. The GAMP 5 checklist decides Category 1, 3, 4 or 5. High-level risk scores through its own weights. If the answers are incomplete, the document prints "not yet established" rather than a level — a missing answer can only raise a score, so it is never quietly rounded down.
Signatures that mean something. Each signing takes the signer's password, prints the meaning of the signature with a UTC manifestation, and binds a SHA-256 hash of the document content. Edit a section afterwards and the signature is marked superseded rather than silently carried forward. The record is append-only.
It issues on your paper, not ours. Organisation, site, SOP title, CSOP number, per-document-type format number and version, and the cover logo are all tenant data. Blank fields print an em dash — the system will not fabricate a document number.
Want it run against one of your own formats? Ask for a walkthrough and we will load your annexure layout into a demo tenant.