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Regulated Industry Compliance

Automate Your Computer System Validation 21 CFR Part 11 Compliance with Opkey

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

What Is 21 CFR Part 11 — and Why Is It So Hard?

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.
Electronic Records
Immutable records with secure audit trails documenting every create, modify, and delete action.
Electronic Signatures
Unique, two-factor verified e-signatures linked to IQ/OQ/PQ sign-offs, legally binding and fully traceable.
CSV & Validation (IQ/OQ/PQ)
Installation, Operational, and Performance Qualification protocols with GAMP 5-aligned risk-based testing.
GxP Operational Controls
Authority checks, segregation of duties, and session controls meeting GxP and predicate rule requirements.
6–12 Mo
Typical IQ/OQ/PQ cycle per system
1000s
Pages of manual CSV documentation
70%
GxP teams stuck in reactive mode
$2M+
Annual CSV compliance spend per ERP

Opkey Is GxP Validated & 21 CFR Part 11 Compliant

SOC 2 Type II · ISO 27001 · GAMP 5 Aligned · HIPAA · ISO 42001
View Compliance Details
Part 11 Compliance, Automated
Six Pillars of Automated 21 CFR Part 11 Compliance.
Click any pillar to see how Opkey automates the most challenging aspects of Part 11 compliance and Computer System Validation.
Immutable, Timestamped Audit Trails for Every Action
21 CFR Part 11 requires secure, computer-generated, time-stamped audit trails that independently record the date and time of operator entries and actions. Opkey automatically captures every test execution, approval, configuration change, and user action in a tamper-proof audit log.
  • Every test execution recorded with timestamp, user ID, and result
  • Configuration changes tracked across environments with before/after snapshots
  • Complete chain of custody for all validation artifacts
  • Exportable audit reports in FDA-accepted formats
Electronic Signatures Linked to Unique User Identities
Part 11 mandates that electronic signatures are unique to one individual, cannot be reused, and are linked to their respective electronic records. Opkey enforces role-based access with authenticated electronic approvals at every stage of the validation lifecycle.
  • Unique user authentication tied to every approval and sign-off
  • Role-based access controls — testers, reviewers, approvers
  • Electronic signature manifests for IQ/OQ/PQ protocols
  • Signature meaning captured (author, reviewer, approver)
Automated Computer System Validation — IQ, OQ, PQ
Computer System Validation (CSV) requires documented evidence that a system consistently produces results meeting predetermined specifications. Opkey automates the most labor-intensive parts of CSV — test script creation, execution, and documentation — cutting validation cycles by 50% or more.
  • Auto-generate IQ/OQ/PQ test scripts from system configurations
  • Execute validation protocols across Oracle, Workday, UKG, and 15+ ERPs
  • Self-healing tests maintain validated state through updates
  • Automated traceability matrices linking requirements to test evidence
Operational Controls That Prevent Unauthorized Access
21 CFR Part 11 requires authority checks ensuring only authorized individuals can use the system, sign records, or alter records. Opkey provides granular, role-based access controls with segregation of duties across the entire validation workflow.
  • Granular role-based permissions for test creation, execution, and approval
  • Segregation of duties — no single user can author and approve
  • Session timeouts and automatic logoff policies
  • Complete user access audit log for inspection readiness
ALCOA+ Compliant Data Throughout the Lifecycle
Regulatory agencies expect data that is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA+). Opkey ensures every piece of validation evidence meets ALCOA+ principles through automated capture, immutable storage, and complete traceability.
  • Attributable — every record tied to a specific user and timestamp
  • Contemporaneous — data captured at the time of the activity
  • Original — primary records preserved in their original format
  • Accurate — automated test execution eliminates transcription errors
From Periodic Revalidation to Continuous Validated State
Traditional CSV requires costly periodic revalidation. Opkey shifts this paradigm — with self-healing tests and automated change impact analysis, your systems remain in a continuously validated state through every vendor update, configuration change, and process evolution.
  • Self-healing tests auto-adapt to UI and process changes
  • Argus AI detects impacted validations after every system change
  • Automated regression ensures validated state after every update
  • Continuous compliance monitoring replaces periodic revalidation

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50%
Faster IQ/OQ/PQ cycles
100%
Audit trail & e-signature coverage
Zero
Manual CSV documentation
24/7
Continuous validated state
Does My Application Require CSV?
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.

ERP & Finance Systems

CSV Required
Oracle Cloud, Workday, SAP — when used for GMP batch records, procurement of raw materials, or quality-critical financial processes.

Quality Management (QMS)

CSV Required
Veeva Vault QMS, Honeywell TrackWise, MasterControl — CAPA, deviations, change control, and document management.

Laboratory Systems (LIMS)

CSV Required
LabWare, STARLIMS, Empower — analytical testing, stability studies, environmental monitoring data.

Manufacturing (MES)

CSV Required
Rockwell PharmaSuite, Siemens Opcenter — electronic batch records, in-process controls, equipment qualification.

Clinical & Regulatory

CSV Required
Veeva Vault RIM, Oracle Argus Safety, Medidata Rave — clinical trial data, adverse event reporting, regulatory submissions.

Document Management (eDMS)

CSV Required
Veeva Vault, Documentum, OpenText — SOPs, batch records, validation protocols, and controlled documents.
Systems Opkey Validates for 21 CFR Part 11 Compliance

Oracle Cloud (Fusion)

12,000+ pre-built tests

Workday

6,000+ pre-built tests

Veeva Vault QMS

2,500+ pre-built tests

Veeva Vault RIM

1,800+ pre-built tests

Honeywell TrackWise

2,000+ pre-built tests

ServiceNow

2,500+ pre-built tests
Built for Every Regulated Industry.
Whether you're running GMP, GLP, GCP, or GDP processes — Opkey understands the GxP regulatory landscape your ERP operates in.
Pharmaceuticals
GMP batch records, drug manufacturing CSV, clinical trial data integrity
Medical Devices
Design History Files (DHF), CAPA validation, post-market surveillance
Biotechnology
Biologics License Applications (BLA), cell & gene therapy CSV
Food & Beverage
FSMA/HACCP compliance, GAMP 5-aligned production record validation
Cosmetics
Product safety dossiers, ingredient traceability, GxP labeling controls
Clinical Research (CROs)
21 CFR Part 11 for EDC/CTMS systems, CDISC data validation, eTMF
Enterprise-Grade Security. Audit-Ready Platform.
Opkey doesn't just help you validate your ERP — our platform itself is built to the highest security and compliance standards.

SOC 2 Type II

ISO 27001

GDPR

HIPAA

21 CFR Part 11 Ready

GAMP 5 Aligned

SSO / SAML 2.0

Role-Based Access

Data Encryption (AES-256)

Audit Trail Export

Multi-Tenant Isolation

99.9% Uptime SLA

FAQ

Frequently Asked
Questions

Everything you need to know

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21 CFR Part 11 is the FDA regulation establishing criteria for electronic records and electronic signatures. It applies to any FDA-regulated organization — pharma, biotech, medical devices, food & beverage — that uses electronic systems for GxP-regulated processes including manufacturing batch records, clinical trial data, quality management, and regulatory submissions.

Opkey auto-generates Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test scripts directly from your ERP system configurations. Instead of manually authoring thousands of pages of validation protocols, Opkey creates executable IQ/OQ/PQ scripts, runs them with full traceability, and produces GAMP 5-aligned documentation — cutting CSV cycles by 50% or more.

Yes. Opkey's approach aligns with GAMP 5 (ISPE Good Automated Manufacturing Practice) guidelines for risk-based validation. Software categories 3, 4, and 5 each get appropriate validation depth — from standard configuration verification for Category 3 COTS software to comprehensive IQ/OQ/PQ for Category 5 custom applications.

This is Opkey's key differentiator for GxP environments. Self-healing tests automatically adapt when Oracle, Workday, or UKG push updates. Argus AI performs change impact analysis to identify which IQ/OQ/PQ protocols are affected. Your systems stay in a continuously validated state — eliminating costly periodic revalidation that plagues manual CSV programs.

Opkey supports CSV for Oracle Cloud (Fusion), Workday, UKG, SAP, Coupa, ServiceNow, Salesforce, and 15+ enterprise applications. For life sciences specifically, Opkey integrates with Veeva Vault, TrackWise, and other GxP-critical systems, with 30,000+ pre-built test cases covering standard business processes and predicate rule requirements.

Opkey holds SOC 2 Type II, ISO 27001, GDPR, and HIPAA certifications. The platform is built with AES-256 encryption, role-based access controls with segregation of duties, SSO/SAML 2.0 support, and multi-tenant isolation. Our architecture meets the operational control requirements of 21 CFR Part 11 §11.10 and the electronic signature requirements of §11.50–§11.200.

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