RSM Life Science Essentials Solution

kiadó: RSM Product Sales LLC

Life Sciences Essentials completes the last mile capabilities to meet FDA/Part 11/cGMP requirements

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.

cGMP and Part 11
  • The standard single signature within Dynamics 365 provides for the foundational functionality for transaction history compliance.   However, the predicate rules also require reason codes, no default user names or saved passwords, and the ability for dual electronic signatures.  RSM’s Life Sciences Essentials handles all of these while improving the usability of Part 11 signatures in Dynamics 365 by aggregating multiple field signatures on a form into a single prompt.  In addition, the solution enforces specific dual signature approval of BOMs (one for reviewer and one for approver) as well as a qualified suppliers for operational material.  Life Sciences Essentials also meets the regulated process which requires the manufacture date be set when the 2nd ingredient is mixed, and enhances the granularity of costing sheet values.

3PL integration workbench 
  • The 3PL workbench manages physical and financial transactions at supply chain logistic providers.  RSM has built integrations to various partners such as CMOs, CPOs, and 3PLs for incoming and outgoing material transactions including BoL, quantity, lot, and expiration information.  Depending on the level of granularity desired, the solution can pull data for receipts, sales, shipments, customer information, items, and quantity detail to enable planning and inventory accuracy in Dynamics 365.