Find out how to produce quality products and services to best meet business and regulatory requirements.
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Today, many steps within the manufacturing and distribution chain are outsourced, which means they are outside our direct control but we remain responsible when it comes to compliance and quality assurance. However, with so many moving parts in the chain, how can we best deliver robust supplier qualification that ensures vendors are qualified to produce a product or service that meets all quality, business and regulatory requirements?
We all know the risks if we don’t: complaints, recalls, wastage and rework all lead to fines and reputational damage. Ultimately, we want to provide products that are safe, effective and compliant – and a rigorous Supplier Qualification (SQ) platform can help enable that objective.
Firstly, the SQ solution should be able to handle all type of supply: Products (finished medicinal products or devices); Services (transport, analytics, calibration, waste disposal, audits etc.); and IT (hosting, software, hardware, maintenance etc.). Depending on what is supplied, the qualification process could look very different and various areas will fall under different jurisdictions:
Supplier selection: Procurement
Initial Quality Assessment: SQ
Site inspection/audit: Audit Management
Contractual and Legal agreements: Document Management
Periodic reviews: Audit Management
Performance Monitoring: Qualification Events
Although SQ is clearly linked to two areas, it is more than capable of playing a role in managing the others. The goal is to build a SQ platform that encompasses every part of the journey. However, there are always challenges along the way. Inconsistencies in evaluation and non-standardized processes often act as roadblocks to efficient SQ. To add to the complexity, IDMP now mandates that suppliers and manufacturers must be specified using the identifier listed in the Organization Management System.
The Amplexor Life Sciences Suite SQ solution endeavors to cover all these bases. We start with the master data and wrap it around multiple components covering practically every aspect of SQ:
Quality event management
These are then presented to the user via an intuitive and actionable dashboard, which provides access to reports, supplier status, KPIs, upcoming qualification events, qualification history, and links to related processes, such as audits.
With the recent redesign, now is the perfect time to explore Amplexor SQ solution. It will help you navigate the complicated waters of vendor validation, ensuring you can qualify suppliers quickly and accurately, while providing total visibility of your relationships.
Siniša is a Senior Life Sciences Consultant within Product Management team. He applies his detailed knowledge of pharmaceutical processes and documentation to the areas of business process analysis, optimization of software solutions and demonstration of their capabilities. He started his professional career at Pliva (now the TEVA Group), where in addition to his responsibilities in manufacturing, he engaged in a successful EDMS implementation project. He later joined KRKA’s Regulatory Affairs Department, and finally moved to Amplexor in 2008. Siniša received his Bachelor of Science degree in Pharmacy from Zagreb University.