BTEC adds eQMS to its portfolio of training assets
Published Apr. 13, 2016
BTEC recently purchased its first electronic Quality Management System (eQMS) to replace the traditional paper system it has used since its inception. In addition to increasing the efficiency of the operations and contract services groups, the software will also allow BTEC instructors to enhance curriculum in GMP operations. BTEC’s undergraduate and master’s degree students will pass this benefit to local biomanufacturing companies that utilize some type of eQMS to help meet Good Manufacturing Practice (GMP).
After a competitive bidding process, BTEC selected ACE (Adaptive Compliance Engine™) from PSC Software, a division of PSC Biotech. ACE was selected based on its overall long-term cost, available features, and ease of implementation and administration. BTEC has started the implementation of document control for SOPs and Master Batch Records. It will eventually add workflows for Corrective Action and Preventative Action (CAPA), auditing, and inspection management. BTEC has a sandbox instance that will allow staff to evaluate workflows before implementing them in the production system. Instructors can use the sandbox to simulate “bad” workflows, i.e. workflows that are not compliant or workflows that are compliant but are mistake-prone and/or operationally inefficient.
For more information about ACE, see www.pscsoftware.com/software/ACE/overview.