Prepare For An ISO 13485 Audit Of Computer System Validation
When preparing for ISO 13485:2016 certification audits, many medical device manufacturers are learning of new expectations for computer system validation.
For example, software validation is now expected for Quality Management Systems in addition to the systems used in production, monitoring and measuring equipment. And, validation activities and approaches are now required to be proportionate to associated risks.
Our validation consultants will help you implement a proven risk-based validation methodology, educate your staff in CSV best practices, and validate your systems.
Get ready for your ISO 13485 auditBy the day of the audit, they demonstrated an understanding of software validation. Additionally, they made great strides with the validation activities in their Compliance Plan.
Customer Success Story
An ISO 13485:2003 certified medical device component manufacturer was preparing for certification on ISO 13485:2016. During a pre-audit meeting, the auditor informed the company that he would be taking a close look at the organization’s computer system validation (CSV) documentation. The company reached out to ProPharma because they didn’t even have a system validation program.
Our consultants worked with the company to implement risk-based CSV SOPs, develop a Compliance Plan, and provide CSV training. By the day of the audit, the organization was able to demonstrate an understanding of software validation and show substantial progress towards completing the validation activities in their Compliance Plan.
We know how to prepare your computer system validation program for an ISO 13485 audit.
Our team will:
- Review your current Risk Assessment SOPs and update them to meet the best practices used by Medical Device manufacturers
- Assess your current Computer System Validation SOPs and templates and update them to utilize risk-based practices for documentation and testing
- Identify ISO 13485 software validation gaps and define a practical, efficient process for retrospective validation
- Write a computer system Validation Master Plan to document your strategy and timeline for achieving full compliance with ISO 13485’s computer system validation requirements
- Assist with validating your computer systems at the support level your organization needs, ranging from ad-hoc coaching to fully outsourced validation services.
Get Ready For Your ISO 13485 Audit
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