No automatic-compliance claim
The platform supports controlled workflows; the regulated company still assesses intended use and validates its configured use.
PHARPRO DVS Trust Center
Enterprise evaluation built on evidence—not compliance slogans.
A transparent framework for evaluating product fit, regulated controls, validation responsibility, security evidence and open actions before a pilot or deployment.
Validation-specific workflowHuman-reviewed outputControlled evaluationNo confidential data required to start
Trust principles
What PHARPRO commits to during enterprise evaluation
Human accountability
Drafting intelligence supports preparation. Qualified users remain responsible for review, correction, approval and validation decisions.
Evidence over marketing
Security, validation and certification statements are made only when supported by current documentation.
Evaluation domains
The enterprise due-diligence structure
Product and intended use
- Product and workflow overview
- Supported lifecycle records
- Customer intended-use boundary
Identity and access
- User roles and permissions
- Account lifecycle responsibilities
- Segregation and administrator oversight
Records and traceability
- Requirements and test relationships
- Review and approval workflow
- Audit-trail capability and review needs
Validation responsibility
- Supplier and customer responsibilities
- Risk-based validation approach
- Configuration and release evidence
Change and support
- Release and change communication
- Issue and support escalation
- Customer impact assessment
Security and continuity
- Hosting and data-flow questions
- Backup, recovery and monitoring evidence
- Independent evidence status and actions
Evaluation output
A decision record, including what remains open
A qualified evaluation should end with a documented view of product fit, control fit, validation responsibilities, available evidence and open actions. Missing certifications or independent reports must remain visible until completed—not replaced by broad compliance language.
Fit check
Confirm use case and due-diligence scope.
Evidence review
Review current product, validation and technical information.
Open actions
Record security, legal, validation or configuration gaps.
Decision
Proceed to pilot, request remediation or stop.
Frequently asked questions
Questions regulated teams ask first
Does PHARPRO DVS make a company automatically Part 11 compliant?
No. DVS provides controls designed to support a Part 11 and Annex 11 assessment. Compliance depends on intended use, configuration, procedures, infrastructure, validation and ongoing governance.
Who is responsible for validating DVS?
The regulated company remains responsible for validating its configured intended use and approving release. PHARPRO can provide implementation and validation support.
Does PHARPRO claim certifications that are not documented?
No. Certifications, independent test reports and licenses are disclosed only when current and verifiable. Any unavailable evidence should be recorded as an evaluation action, not implied.
Can PHARPRO respond to a supplier questionnaire?
Yes. Qualified prospects can submit their supplier and technical due-diligence questions for a scoped response.
Make the next decision with evidence.
Start with a focused evaluation. PHARPRO will confirm fit, required controls and the most defensible next step before asking your team to scale.
Request a DVS evaluation