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ISO 13485:2003 is an example of an international quality standard that highlights the importance of supplier controls and supplier SCAR. This standard applies to medical device companies and manufacturers. Under Clause 4.1, they are required to identify not only the outsourced processes (which refer to suppliers), but also the controls for those processes. The outsourced processes must be identified within the QMS, which means the supplier SCAR process must also be integrated within the system.
It is important to note that controls are expected for both permanent and temporary outsourced processes. The extent of controls depends on the risk involved and the importance of the outsourced process.
As part of its harmonization efforts, the U.S. FDA launched a voluntary pilot program in 2012 to utilize inspection results based on ISO 13485:2003. Manufacturers subject to the FDA's 21 CFR 820 requirements are eligible to participate under the program. They may submit to the FDA their most recent audit report based on ISO 13485:2003. Given the FDA's approach, manufacturers should take advantage of the overlap in FDA and ISO standards pertaining to supplier control and supplier SCAR and use the same documentation for compliance to both.
For pharmaceutical, biotechnology, and other regulated companies under the jurisdiction of the FDA, cGMP regulations offer guidance on how to control the supplier chain and with it, the supplier SCAR process. Pharmaceutical and other regulated companies cannot pass on cGMP compliance to suppliers. They are ultimately responsible for making sure their suppliers meet requirements specific to the materials, services, or processes they provide, including the corrective action and preventive action (CAPA) and Supplier Corrective Action Request processes.
MasterControl's Supplier SCAR solution is designed to automate the Supplier Corrective Action Request process and extend a company's CAPA compliance process to its suppliers. MasterControl provides a centralized location for all quality-related processes and documents, so users will find all relevant documentation in one place. MasterControl is web-based so it can connect users from virtually anywhere.
MasterControl SCAR™ provides the following features and benefits:
To learn more about MasterControl's supplier SCAR solution contact a MasterControl representative or call 800-825-9117.