Pharma Validation Governance Tool
Manage IQ, OQ and PQ validation digitally, with templates, electronic signatures, audit trails and one repository for every protocol, test script and report.
Validation without the paper trail
Validation is mandatory in pharma, and slow when it runs on paper, spreadsheets and email. Our governance tool digitizes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Every step is traceable and controlled, in line with FDA, GxP and 21 CFR Part 11 requirements, and you are ready for inspection at any time.
Problems it solves
- Manual IQ, OQ and PQ documents and approvals
- No real-time traceability or version control
- Audit findings caused by inconsistent records
- Slow validation delaying equipment and system release
- Little visibility of where each validation stands
Main features
- IQ, OQ and PQ workflows: predefined templates and protocols for each qualification stage.
- One validation repository: all documents, protocols, test scripts and reports in one secure place.
- Compliance controls: audit trails, electronic signatures and controlled document management for FDA, GxP and 21 CFR Part 11.
- Audit readiness: validation reports and dashboards available on demand.
- Access and security: role-based access, encryption and governance policies.
What you get
- Shorter validation cycles
- Fewer documentation errors and less rework
- Lower risk through standard processes
- Better data integrity
- Lower compliance costs
- Faster release of equipment, systems and products
Why our Validation Governance Tool
It is built by our life sciences team, who work with GxP validation on SAP projects.
- GxP experience: designed around how pharma QA and validation teams work
- Part 11 controls: electronic signatures, audit trails and controlled documents built in
- Templates included: predefined IQ, OQ and PQ templates to start from
- Supported by us: implementation and support from our life sciences team
Frequently asked questions
What is a validation governance tool?
Software that manages IQ, OQ and PQ validation digitally: protocols, test execution, approvals, signatures and reports, with a full audit trail.
Which regulations does it support?
It is designed to support FDA, GxP and 21 CFR Part 11 requirements, including electronic records, electronic signatures and audit trails. Each company remains responsible for its own validation and compliance.
How does it speed up validation?
Templates, automated workflows and electronic approvals replace paper and email, so each qualification stage moves faster.
How does it help with audits?
All validation records are in one place with version history and audit trails, and reports can be produced on demand.
Who uses it?
Validation, QA and engineering teams in pharma, biotech and medical device companies.
Is validation holding up your releases?
Book a demo and see an IQ, OQ and PQ cycle run from template to signed report.
