THE CHALLENGE
CMP Pharma, Inc., a pharmaceutical company with nearly five decades of industry experience, faced significant challenges in tracking and trending quality systems due to reliance on spreadsheets and paper-based systems. Critical issues arose from the cumbersome process of assigning and managing deviation/change control/complaint/OOS and OOT investigation numbers, at times, leading to delays in identifying and resolving quality issues.
In their quest for a quality management software solution, CMP prioritized dependability, compliance with Part 11 regulations, and cost-effectiveness. After evaluating multiple software providers, they found Dot Compliance to be the optimal choice, offering a tailored solution that met their specific needs while being practical and economical for their operations.
THE SOLUTION
CMP implemented the Dot Compliance eQMS in three phases:
Phase 1: Document control, training management
Phase 2: Deviations, quality events, CAPA, complaint management, protocol building
Phase 3: Change controls, supplier management, audit management
Despite facing challenges during implementation, including changes in project managers and training methods, CMP adapted by conducting internal training sessions to ensure smooth integration.
Melanie Little, the company’s QA Director mentioned: “Dot Compliance’s eQMS has truly been an asset in tracking our quality systems. Policies and procedures can be assigned a retraining frequency within the eQMS. When training is due, employees receive email notifications that training is required. As documents are revised, the system automatically supersedes/archives the older version once the revised document is made effective. The eQMS is a single repository for our GMP documents”.
