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ISO Software Validation Template
Verification vs. Validation
With verification and validation, we aim to develop a “level of confidence” that the software or device meets all requirements and user expectations.
Verification (internal process)
- Automated testing, static/dynamic analysis, code inspection, walkthroughs, etc.
- Checks for regulations, specifications, imposed conditions.
- Building product right?
Validation (often external process)
- Assurance software meets operational needs of customer or stakeholders. Confirmation by examination and objective evidence that requirements are consistently fulfilled. Comprehensive testing, inspections, analyses, simulation, etc.
- Acceptance, suitability.
- Building right product?
Validation
- Identify Processes.
- Requirements & Specifications (defined by user).
- Requirements: reflect the stated or implied needs of the customer, and may be market-based, contractual, or statutory, as well as an organization's internal requirements.
- Specification: a document that states requirements. It might include: drawings, patterns, documents, etc.
- Needs & goals of stakeholders.
- Defined as functionality.
- Process Parameters.
- Desired Output.
- Regulations.
- Decide on verification and/or validation.
- Validation protocol.
- Perform & document the following (what, how, quantity, when to verify/measure; define acceptance/rejection criteria and required documentation):
- Installation qualification (IQ).
- Operational qualification (OQ).
- Performance qualification (PQ).
- Determine continuous process controls.
- Generate final report and approval.
- Control the process continuously.
- Revalidate process as appropriate.