Computer System Validation is a documentation problem long before it is a software problem. The system under validation may be a LIMS, an ERP module, a chromatography data system or a spreadsheet doing a GxP calculation — what an inspector examines is the pack: the user requirements, the risk assessment, the test evidence, the traceability matrix, and who signed what, when.
Most teams assemble that pack in Word. Formats drift between authors, versions live in filenames, and approval arrives as a scanned signature that is bound to nothing. The pack passes until the day someone asks which version of the requirement the test evidence actually traces to.
We deliver the pack on ValiDoc, our own validation documentation platform. Documents issue on your letterhead with your SOP and format numbers. GxP relevance, GAMP 5 category and high-level risk are computed from scored checklists instead of asserted. Signatures carry the signer's password, a printed meaning with UTC timestamp, and a SHA-256 hash of the content — so an edit after signing shows up as superseded rather than passing quietly.
Typical engagement: discovery and format review in week one, tenant configured in week two, then authoring alongside your QA function. Consultancies carrying validation for multiple clients run each client as its own tenant.