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?

• 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.