Seal is designed for regulated life-sciences operations. The data model, audit trail, electronic signatures, and validation posture are built to support inspection scope — not to add another silo your QA team has to fight to use.
Audit / live cycle01 / 05
“Show me how requirement 47 traces to verification.”
When an inspector asks how requirement 47 traces to verification, the answer is one click — not a folder hunt. Audit trail, signatures, and evidence chains live as structured records. Inspections stop being crises and start being walkthroughs.
02 / The architecture
Five systems become one.
QMS, ELN, LIMS, MES, and Clinical on the same data model — one auth, one audit trail, one validated platform. Five integration projects become zero. Five validation packages become one. The boundary where compliance drifts no longer exists.
03 / The validation
Stop revalidating the same thing.
Releases do not invalidate your configuration. Under GAMP 5, Seal validates the platform; you validate what is actually changing in your operation. Your CSV team stops repeating last quarter's work and starts working on the next problem.
04 / The automation
UAT runs while you sleep.
Acceptance tests written as structured requirements; neil executes them against your live configuration overnight. Regression coverage updates as your forms and workflows evolve. Six weeks of UAT compresses to six hours of evidence — traceable, reviewable, signed.
We'll run a regulatory walkthrough tailored to your scope — sponsor, CDMO, biologic, device, combination — and your submission targets. Your QA, RA, and CSV leads on one side; ours on the other.