Module19 April 20264 min read
Module spotlight: Process Management & validation
A process you cannot fully inspect is a process you must validate. Process management and continuous process verification keep your manufacturing processes defined and in control.
By MoniDoseQMS Team
Some processes produce results you can fully verify by inspection. Many do not — and those have to be validated and kept in control. Process management defines your processes, and continuous process verification keeps proving they stay capable over time.
What you can do
- Define and document manufacturing and quality processes
- Validate processes whose output cannot be fully verified
- Run continuous process verification to confirm ongoing capability
- Connect processes to the products and equipment they involve
Why it matters
ISO 13485 §7.5.6 requires validation of special processes, and continuous verification provides ongoing assurance. Defined, validated, monitored processes are how you keep quality consistent batch after batch.