MSD Carlow has been a customer of ATS since 2011. This facility was enabled with Werum PAS-X Manufacturing Execution System (MES) from Day 1. ATS played an active role in implementing the original system design in accordance to Quality Assurance Plan (QAP) that defined the techniques, procedures, and methodologies that was used for the core MES solution. The plan also defined the deliverables required that assured the MES solution and its components are developed in accordance with the approved quality standards i.e. FDA.
ATS continue to support MSD Carlow on the execution of validation protocols of Mater Batch Records (MBR) development and maintenance of the core system design.
To discuss ATS experience and best practice of Software Development Life Cycle (SDLC) management, don’t hesitate contacting us and we will arrange for one of our validation consultants to discuss your requirements.
Image: Army Medicine,
Microemulsion could allow vaccines to be stockpiled long-term,
flickr.com, (CC BY 2.0)
