Quality and Traceability Matters in Life Sciences Industry

Pharmaceutical, biotech, medical device manufacturers and other organizations in the life sciences industry provide life-changing products and value to customers. High quality products are expected and there is little room for mistakes, especially when a mistake can impact patient safety or health. Traceability requires close attention to detail and speed when a recall must be initiated. A digital business management solution will strengthen inventory management and the supply chain, as well as expedite the identification of each component with a quality issue.

As indicated in “Life Sciences: 6 Ways to Thrive in a Digital Future,” an eBook, minutes matter when it comes to saving lives. For life sciences organizations, managing quality issues for every component and every device is crucial, no matter whether they are located in house or at a customer site. Strong traceability requires close collaboration with supply chain partners and the ability to capture detailed product history documentation for each product. This level of data management simply can’t be trusted to spreadsheets or specialty software. Life sciences organizations need a unified, digital management platform, like MAXLife.

Strengthen Data Management and Control with MAXLife

Built on the comprehensive Microsoft Dynamics 365 platform, MAXLife is validation-ready and offers powerful ERP, CRM and BI functionality in a seamless, integrated solution. MAXLife provides life sciences companies with these key advantages:

  • Strengthen supply chain: Support a distributed supply chain and encourage collaboration among contract manufacturers, 3PLs and other important supplier relationships.
  • Improve inventory management: Forecast inventory needs and maintain appropriate inventory levels to optimize operations while reducing the risk for expirations or obsolescence.
  • Gain product configuration control: Manage ‘as built’ and ‘as maintained’ configurations of products and be confident that you know exactly which product configurations exist at each customer site.
  • Maintain traceability: Track ECN through rapid product changes and use audit trails to maintain continuous traceability details. Detailed serial and lot number traceability supports quick audits and, more importantly, quick recalls.
  • Support regulatory compliance: Strong traceability throughout the supply chain and product lifecycle also supports compliance with a variety of industry regulations, including 21 CFR. Robust reporting features streamline the audit process and regulatory reporting obligations.

Quality data is necessary to produce quality products. Life sciences organizations can’t trust such critical data to manual means or spreadsheets. Download the eBook and contact Merit Solutions for more information about gaining control and visibility over data with MAXLife.

By Merit Solutions, a Global Microsoft Partner and Business Process Consultant

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