RSM Life Science Essentials Solution

Life Sciences companies like Pharmaceutical and Medical Device Manufacturers that are struggling to comply with Current Good Manufacturing Practices (cGMP), 21 CFR Part 210 & 211, Part 11, and Part 820 in their ERP systems, require a subset of capabilities to meet compliance standards. The need to track, trace and plan material at supply chain partners such as Contract Manufacturing Organizations (CMO), Contract Packaging Organizations (CPO), and Third-Party Logistic (3PL) companies are also a common requirements.   RSM has built these capabilities into Dynamics 365 Finance & Supply Chain Management with our Life Sciences Essentials solution.

Transactions considered critical to cGMP include compliance with 21 CFR 210 & Part 11 (single and dual electronic signatures), material control, and manufacturing restrictions.  In addition, the prevalent business model of outsourcing drives the need to gain visibility and traceability across the supply chain from Active Pharmaceutical Ingredient (API) to CMO to CPO and finally to 3PL.   From a commercial perspective, the ability to also plan demand, inventory, and production across the entire supply chain is key to successful fulfillment goals.  RSM has built the “last mile” capabilities on top of Dynamics 365 to support both manufacturing in house and outsourced to service providers.