Validation planning
Help define intended use, system boundaries, risk assessments, and validation responsibilities with your Quality team.
Validation & Compliance Support
Build evidence into the system lifecycle.
Support risk-based computer system validation, lifecycle procedures, and inspection readiness for the intended use of your systems.
Discuss this serviceSERVICE SCOPE
How we can help
Requirements and evidence
Support requirements traceability, test planning, execution coordination, and documented issue resolution.
Lifecycle procedures
Develop or refine system lifecycle SOPs and processes for changes, releases, access, and periodic review.
Inspection readiness
Review documentation completeness, identify evidence gaps, and support readiness activities and remediation planning.
OUR APPROACH
From a clear scope to a practical next step.
Every engagement starts with an agreed scope. The exact sequence depends on your process, team, and systems.
- Agree intended use and Quality oversight.
- Assess risks and define the evidence approach.
- Support testing, traceability, and issue resolution.
- Review documentation and hand over lifecycle responsibilities.
POTENTIAL DELIVERABLES
Something your team can use.
- Validation plans and risk assessments
- Requirements traceability and test documentation
- System lifecycle SOPs or procedure updates
- Documentation gap assessment and action plan
Services can support your existing systems independently of SURAI. Activities, deliverables, responsibilities, and access requirements are agreed in writing. Compliance decisions and approvals remain with your organization; no certification or inspection outcome is guaranteed.
LET’S START WITH YOUR NEEDS
Tell us what you want to improve.
Share the process or technology challenge you would like to address.