Global regulatory compliance mandates continue to evolve rapidly and aim directly or indirectly to ensure the quality and traceability of medical products delivered to the market. To ensure patient safety regulatory authorities continue to work more closely in a global and harmonized environment.
Some examples of regulations that are harmonising across larger regions are E2B (R3), ISO IDMP standards for human medicines and EN ISO 13485:2012 standard for medical devices. These regulations are being finalised for adoption over the next few years.
In this webcast, Mrs. Mallika Rajasekaran, Associate Director, Product Management at ArisGlobal discussed why and how life sciences companies need to understand this direction and ensure that internally more rigid policies and methods are put in place to ensure regulatory compliant products make it to the market. To ensure this compliance, the current exchange of regulatory compliant information between the regulatory department and the manufacturing department needs to be re-evaluated. It is clear that existing processes are not always optimal resulting in delays and, in some cases, human error. It is essential to optimise these processes to make them more efficient and less error prone. A key aspect of optimisation is to look at integrating a Regulatory Information Management System (RIMS) and an Enterprise Resource Planning (ERP) system.
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