Global regulatory compliance mandates continue to increase in number and evolve rapidly in complexity. Most of these regulations aim directly or indirectly to ensure the quality and traceability of medical products delivered to the market. Ensuring the safety of the patient through monitoring that compliant products are delivered to the patient is the regulators’ key priority. To enforce this, 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 standards1 for human medicines and EN ISO 13485:2012 standard2 for medical devices. These regulations are being finalised for adoption over the next few years.
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.