Custom GxP Software
Software builtvalidation-ready.
Most vendors build software, then bolt compliance on. We build the other way around: audit trails, Part 11 e-signatures and access controls are in the architecture from the first line of code — and the validation package ships with the product.
Compliance by architecture
Four things we never retrofit
Audit trail, from line one
Every create, modify and delete is captured with the who, what, when and why — immutable and queryable, not bolted on before an audit.
Audit trail ✓ E-sign ✓ Part 11 ✓
Part 11 e-signatures
Unique credentials, signature manifestation and meaning-of-signature are core primitives, mapped to 21 CFR Part 11 and EU Annex 11.
Audit trail ✓ E-sign ✓ Part 11 ✓
Access control & data integrity
Role-based permissions, segregation of duties and ALCOA+ record protection designed in — so integrity is a property, not a policy.
Audit trail ✓ E-sign ✓ Part 11 ✓
Validation package included
URS, risk assessment, IQ/OQ/PQ and traceability ship with the software, so your compliance burden is already documented on day one.
Audit trail ✓ E-sign ✓ Part 11 ✓
How we build
A GxP SDLC, run in the open
Discover
We map your process, users and regulatory context into a User Requirement Specification your quality unit can approve.
Design
Functional and design specs with a risk assessment up front — GAMP 5 Category 5 handled as Category 5, deliberately.
Build
Iterative development against the spec, with the audit trail, e-signature and access-control layers in from the first commit.
Qualify
IQ/OQ/PQ authored and executed against the requirements, producing a traceability matrix with no gaps.
Support
Change control, periodic review and revalidation triggers keep the validated state intact through every release.
Ships with every build
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Explore our GxP software for questionnaires, column lifecycle, training, documents, ERP, pharma labels, APQR, calibration and preventive maintenance.