Regulatory

Built for GxP.

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.
Seal answers
REQ-047 → DV-103 → VER-047 · pass · ±2.1% accuracy
signed · L. Patel · 2026-03-14 · 14:22 UTC
Infosec
trust.seal.run
SOC 2 Type II, encryption, vulnerability management, subprocessors, business continuity.
Technical reference
docs.seal.run
Detailed reference for 21 CFR Part 11, EU Annex 11, ISO 13485, CLIA, validation, change control, infrastructure.
Talk to us
Regulatory walkthrough
A session tailored to your scope, submission targets, and validation posture.

Frameworks supported

FDA · United States
21 CFR Part 11
Electronic records & signatures
21 CFR 211
cGMP for finished pharmaceuticals
21 CFR 820
Quality system regulation
21 CFR 4 · 600s · 58
Combination products · biologics · GLP
EU · EMA
EudraLex Vol 4
EU GMP
Annex 11
Computerised systems
Annex 1
Sterile manufacturing
EU MDR · IVDR
Medical devices · diagnostics
ICH
Q7 · Q9 · Q10
GMP · risk management · PQS
Q11 · Q12
Drug substance · lifecycle / ECs / PACMP
Q13 · Q14
Continuous mfg · analytical procedures
E6 (R3)
Good clinical practice
ISO · Industry
ISO 13485 · 14971
Devices QMS · risk
ISA-88
Batch control · recipe model
GAMP 5 (2nd ed.)
Computerised system validation
ALCOA+ · PIC/S · CLIA
Data integrity · GMP · clinical labs

Reference detail · docs.seal.run

Regulatory standards
How Seal supports each framework, with controls mapped to specific clauses.
21 CFR Part 11EU Annex 11ISO 13485CLIA
Validation & CSV
Shared-responsibility validation under GAMP 5. What Seal validates, what you validate, how releases evolve without re-validating from scratch.
Validation frameworkImplementationData migrationRelease process
Security & infrastructure
Hosting, encryption, identity & access, disaster recovery — operational controls infosec auditors verify.
InfrastructureData storage & securityDisaster recoverySingle sign-on

What we believe

01 / The audit
Inspection becomes routine.
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.

Operational blueprints

QMSQMS · ValidationDocument ControlChange ControlDeviationCAPAAuditRiskAudit ReadinessTrainingPLM (ICH Q12)Medical Device

Evaluating Seal for a regulatory program?

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.