At PEMAC, we understand this and know that pharmaceutical and medical device manufacturers must ensure adherence to the strict rules such as 21CFR Part 11 set down by regulatory bodies like the Food and Drug Administration (FDA).
Maintenance Teams must meet traceability, authentication and auditing requirements. All vendors must be ISO certified and Maintenance Strategies need to be implemented supporting risk mitigation and continuous improvements. Equipment downtime is a huge additional cost and managing staff and contractors to meet all Health & Safety standards is key.
PEMAC has a strong history working in the Pharmaceutical sector and PEMAC Assets has been developed taking into account our experience with clients.. PEMAC Assets offers you the basic abilities to schedule, plan and track Maintenance work orders and hours, while also delivering sophisticated live reporting. PEMAC CARE, our Health & Safety product, is available and integrated within PEMAC Assets giving you the automated assurance of knowing (all staff are at any time) that Contractors & work permits have been issued, the correct and qualified person has been applied to an order, and that all staff are safe while performing maintenance tasks. PEMAC Assets also contains a fully configurable, paperless Forms module allowing you to define, control and manage paperless workflows across your facility( remove paper from your workflow and alleviate the admin that comes with managing this).
To support you with a new PEMAC partnership, we have developed a Pre-Qualification Pack significantly reducing your onsite validation time therefore lowering your total cost of ownership (TCO). Once live, our intelligent reporting allows Managers to make better decisions on people, stock and inventory so you can follow LEAN or AMIS Strategies and remain ISO55000 compliant.
Below are some further key features of PEMAC Assets. Speak to us directly for further information.