Automate IQ/OQ/PQ protocols, generate FDA-ready audit trails, and maintain a continuously validated state across your GxP-regulated ERP landscape — so your team ships faster without risking compliance.
Trusted by world-class enterprises
The FDA's criteria for accepting electronic records and signatures demands rigorous Computer System Validation (CSV) — including IQ, OQ, and PQ protocols aligned to GAMP 5 guidelines. But manual CSV was built for annual releases, not weekly cloud updates.
Immutable records with secure audit trails documenting every create, modify, and delete action.
Unique, two-factor verified e-signatures linked to IQ/OQ/PQ sign-offs, legally binding and fully traceable.
Installation, Operational, and Performance Qualification protocols with GAMP 5-aligned risk-based testing.
Authority checks, segregation of duties, and session controls meeting GxP and predicate rule requirements.
Click any pillar to see how Opkey automates the most challenging aspects of Part 11 compliance and Computer System Validation.
50%
Faster IQ/OQ/PQ cycles
100%
Audit trail & e-signature coverage
Zero
Manual CSV documentation
24/7
Continuous validated state
Any computerized system that creates, modifies, maintains, or transmits records required under FDA predicate rules — or is used in GxP-regulated processes — requires Computer System Validation. If your system impacts product quality, patient safety, or data integrity, CSV is mandatory.
Oracle Cloud, Workday, SAP — when used for GMP batch records, procurement of raw materials, or quality-critical financial processes.
Veeva Vault QMS, Honeywell TrackWise, MasterControl — CAPA, deviations, change control, and document management.
LabWare, STARLIMS, Empower — analytical testing, stability studies, environmental monitoring data.
Rockwell PharmaSuite, Siemens Opcenter — electronic batch records, in-process controls, equipment qualification.
Veeva Vault RIM, Oracle Argus Safety, Medidata Rave — clinical trial data, adverse event reporting, regulatory submissions.
Veeva Vault, Documentum, OpenText — SOPs, batch records, validation protocols, and controlled documents.
Systems Opkey Validates for 21 CFR Part 11 Compliance
Oracle Cloud (Fusion)
ERP
12,000+ pre-built tests
Workday
HCM / Finance
6,000+ pre-built tests
Veeva Vault QMS
Quality
2,500+ pre-built tests
Veeva Vault RIM
Regulatory
1,800+ pre-built tests
Honeywell TrackWise
QMS / CAPA
2,000+ pre-built tests
ServiceNow
ITSM / GxP
2,500+ pre-built tests
Whether you're running GMP, GLP, GCP, or GDP processes — Opkey understands the GxP regulatory landscape your ERP operates in.
GMP batch records, drug manufacturing CSV, clinical trial data integrity
Design History Files (DHF), CAPA validation, post-market surveillance
Biologics License Applications (BLA), cell & gene therapy CSV
FSMA/HACCP compliance, GAMP 5-aligned production record validation
Product safety dossiers, ingredient traceability, GxP labeling controls
21 CFR Part 11 for EDC/CTMS systems, CDISC data validation, eTMF
Opkey doesn't just help you validate your ERP — our platform itself is built to the highest security and compliance standards.
Accelerate 90% of cloud app configuration, testing and training with the only test automation platform built for enterprise success.
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