Process Validation Procedure

This procedure defines how your organisation validates processes for production and service provision, sterilization processes and sterile barrier systems, and computer software used in the QMS, in production, and in monitoring and measurement.

What's Inside

• Validation Life-cycle Overview
• Determining Whether Validation Is Required
• Validation Master Plan
• Risk-Based Approach
• Validation Procedures and Protocols (7.5.6 a–g)
• Installation, Operational and Performance Qualification
• Statistical Techniques
• Execution, Deviations and Reports

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clause 7.5.6. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.