Software Validation Template Iso 13485. And it adds new validation requirements of software used in the QMS. Validation of computer software is specified in section 416 of ISO 134852016.
What Is Required For Validation Of Software Used In Qms Processes from matrixreq.com
Since it is made for any medical device manufacturer or repackager or even distributor ISO 13485 is very generic. Record of Software Validation The record provides information about software validation results. The new requirement in section 416 reads.
There are two checklist template builders available ISO 13485 Audit Checklist and ISO 13485 Standards Checklist.
The new requirement in section 416 reads. The template documentation covers both ISO 134852003 and FDA QSR 21 CFR Part 820 requirements under one quality system and is thus ideally suited for companies that must comply with both the US FDA and international regulations. Free ISO 13485 Control of Documents Template. The document is optimized for small and medium-sized organizations we believe that overly complex and lengthy documents are just overkill for you.