A system which fulfills the right requirements
The context, environment, in which your system operates is the decisive factor.
It is only in its context that we are able to optimally evaluate the value of the system for your company considering risks, data integrity requirements, the underlying technology and the human factor.
- Your activities are focused on the essential, critical and most valuable features
- During external audits you are competent and convincing
- Your systems remain in a validated state
1 Planning
Elaboration of a validation plan based on system context and initial risk assessment
2 Requirement elicitation and definition
Requirements verification through process experts, testers, developers and suppliers
3 Risik analysis
Risk assessment at different levels for patient, product and data integrity
4 Test planning, analysis and design
Risk-based tests are traceable on each abstraction layer
5 Test reports
Testing provides decision makers with the necessary information regarding the introduction of a new software (version)
6 Validation report
Report comprising all evidence of validation activities
Your System is validated!
With regard to regulatory requirements (e.g. 21CFR11, EU GMP Annex 11) as well internal business, project and development standards.
Case
Customer call: System "eTMF" must be updated due to new extended intended use and a new product release. Can you guide us through the validation process of the new release, which must include implementation of lessons learned from the previous release?
Discussion: Specify and agree on context, scope, goals, timelines, roles & responsibilities, budget and required deliverables. New trials need to be added quickly to the system.
Proposal: 25 calendar days.
Contract: Agreed & signed
Services: Validation and test planning. Creating new release process based on the analysis of previous releases. Create the release plan and report. Guide Team.
Deliverables: Release concept. Updated Validation Plan and Report, Release Plan, release-specific test procedures, Release Report incl. test reporting
Result: New system release validated
Effect: DevOps approach established to implement new vendor releases
Note: Validation Lead of customer shall be guided by Software Validation consultant.