Compliant software for regulated operations — built to be validated from day one.
Beyond validating the systems you already run, Valitech builds custom software for life-science operations. Every application is designed around GxP, FDA 21 CFR Part 11, and EU GMP Annex 11 from the first line of code — audit trails, electronic signatures, and role-based access are built in, not bolted on. Each system ships with its validation package, so it is inspection-ready on the day it goes live.
QMS – Quality Management System
A custom Quality Management System shaped around how your quality unit actually works. We build modules for deviations, CAPA, change control, audit management, complaints, and risk assessment — each with a complete, secure audit trail and Part 11 electronic signatures. Workflows, approvals, and escalations follow your SOPs instead of forcing your process into off-the-shelf constraints.
DMS – Document Management System
A controlled Document Management System that governs the full document lifecycle — authoring, review, approval, versioning, distribution, retirement, and archival. Every action is attributable and time-stamped, documents are released under electronic signature, and access is role-based — so your SOPs, protocols, and records stay controlled and inspection-ready at all times.
LMS – Learning Management System
A Learning Management System that ties training to roles and SOPs. Courses can be assigned automatically when a document changes, with tracking for completion, competency, and read-and-understood acknowledgements, and training records that link directly to your quality system — so “trained before task” is provable at any inspection.
eSign – Electronic Signatures
A 21 CFR Part 11-compliant electronic signature layer that can stand alone or plug straight into your QMS, DMS, and LMS. Every signature is uniquely attributable to its signer, and captures the meaning of the signing (author, reviewer, approver) — permanently and securely bound to the record, with the signer’s printed name, date-and-time stamp, and reason for signing that Part 11 requires. Re-authentication, signature manifestations, and a complete audit trail make every approval legally sound and inspection-ready.
Delivered validation-ready
Every system is delivered with a full validation package — IRA, VP, URS, FS, DS, IQ, OQ, PQ, including RTM/VSR — following GAMP 5 and CSA risk-based principles. The result is software that is not only fit for purpose but demonstrably compliant from go-live.
See the standards we build to, or talk to us about a custom system.