Computer System Vendor Qualification and Management (RiskVal)
Vendor qualification is required by the FDA and ISO 13485. The vendor qualification of most companies is centered on first article inspection of parts. This procedure answers the question: How do I qualify software and hardware vendors.
Provider: BPA Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price: $125.00
Product Detail:
The purpose of this procedure is to describe the requirements and process for the qualification and management of vendors who provide system software, application software, computer hardware, support services, or software development or integration services as required by VAL003 .
The purpose of the qualification is to evaluate the vendor's quality system in order to determine if its products and services are/will be produced with sufficient quality to provide the reliability and performance needed.
The purpose of vendor qualification is to ensure that a quality computer system is being used, and that the vendor's quality system is sufficient to assure the quality of future products as well as modifications to the current product.
The vendor's performance , including quality issues, is reviewed. If a vendor's performance is determined to be unsatisfactory, QA will either ask the vendor to rectify the situation or disqualify the vendor.
