MEDICAL INDUSTRY FOCUS
product company will find an alternate and update the approved manufacturers list to document the change. The CAPA loop is closed through the captured link between the CAPA process and the change process, implementing the new approved manufacturers list. Product-centric QMS provides your extended product team with the controlled access to quality records and product records they need. So, they can see the quality issues and resolutions with respect to the product record. And, they can see all the product record changes, including BOM, approved manufacturers list, and documentation, with respect to the quality process. Without a product-centric QMS, you would need to manually reference between your QMS and your product record control systems (or paper/shared-drive system), require your teams to jump back and forth, and increase your risks of failure to close the loops—ultimately increasing your risk of product failures.
CONNECTING TO DOWNSTREAM SYSTEMS A product-centric QMS system also closes the loop further by connecting with downstream systems. When a product change is released, operations and other impacted
teams need to know, as described in 21 CFR 820.100 (6 and 7). So, product-centric QMS updates the downstream systems they use – often enterprise resource planning (ERP) systems. This automatic integration makes the changes to the product record – product design, product documentation, or supplier information – in the ERP system. When comparing product-centric QMS and document-centric QMS,
this is a priority requirement for product companies. Automated integration is the key ingredient missing from paper-based, hybrid, and document-centric quality systems. Integrating cannot be done automatically with a paper-based system, of course. And, with document-based QMS systems, integrations are incomplete and typically expensive custom coding efforts.
THE BIG DEAL The big deal is that your product enhances and saves lives. With quality process connected with the product record, your visionary product gets to market sooner and works. Closed-loop CAPA enables fast and accurate resolution of issues that improve product quality. The powerful connection between the CAPA process and the product
record encompasses training, product change, and document change processes. These links give engineering the quality information they need and simplify compliance with FDA and other regulatory bodies.
Arena
www.arenasolutions.com
DESIGN SOLUTIONS | MARCH 2019
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