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”.
THE CHALLENGE
Before implementing the Dot Compliance electronic quality management system (eQMS), VLE Therapeutics relied on a paper-based QMS that proved to be time-consuming and prone to human error. VLE Therapeutics determined the need for a solution that would digitize core processes, including document management, training management, deviation management, and corrective and preventive actions (CAPAs). It found these capabilities in Dot Compliance.
THE SOLUTION
To address its top challenges, VLE Therapeutics implemented Dot Compliance’s eQMS solution in two phases. First, the VLE Therapeutics team adopted the document management and training modules to transition from paper to an electronic system. This enabled the company to manage documents electronically and with digital signatures, track document versions, automate training management, and track employee training records.
In the second phase, VLE Therapeutics implemented CAPA and Deviations, further automating and streamlining their quality processes. This resulted in improved efficiency, enhanced control, and data driven decision-making.
Automated workflows for deviations and CAPAs reduced manual effort and improved tracking capabilities. The eQMS provided a central platform for managing all quality processes, fostering greater control and visibility. Builtin dashboards allowed VLE Therapeutics to access key metrics and make informed decisions.
THE BENEFITS
VLE Therapeutics experienced significant benefits after implementing Dot Compliance’s eQMS. The system streamlined workflows, reduced manual tasks, and provided insights into key metrics and data, allowing the quality team to focus on more strategic activities.
The eQMS also facilitated the development and management of training programs, ensuring employees were adequately trained and compliant. The system’s user-friendly interface and intuitive design encouraged employee adoption, leading to greater utilization.
By centralizing document management, training, deviations, and CAPAs, the eQMS improved collaboration and reduced the risk of errors. This helped VLE Therapeutics make informed decisions.
Overall, the implementation of Dot Compliance’s eQMS significantly improved VLE Therapeutic’s quality management processes and helped them achieve their goals.