Satsuma Pharmaceuticals Accelerates Quality Management with Dot Compliance

THE CHALLENGE

Satsuma Pharmaceuticals (Satsuma) is a pharmaceutical innovator that is committed to providing novel treatments to those who suffer from migraine and other debilitating conditions.

Satsuma needed to transition from clinical trials to a commercial operation, but its previous electronic quality management system (eQMS) was not robust enough to effectively enable this transition.

Satsuma realized that it would need an eQMS with processes that align with Good Manufacturing Practices (GMP) and would provide automated vendor management, document control, and training effectiveness tracking.

THE SOLUTION

In its quest for a solution, Satsuma turned to Dot Compliance. The software’s out-of-the-box usability and the vendor module for maintaining vendor qualifications were key factors.

Janera Harris, Senior Director of QA & Compliance at Satsuma said, “The free trial allowed our users to access the system and use the different modules. We met with Dot Compliance weekly to answer any questions that arose. This allowed our users to see if the system met their requirements.”

In terms of usability, Harris said, “We did not need to customize the product and Dot Compliance was usable for us right out of the box. In addition, the projected amount of time from setup to launch aligned with our timeline.”

BENEFITS

The Dot Compliance eQMS significantly improved document revisions, change control, and quality event processes and made it easier to capture data and track signatures, leading to greater efficiency and cost savings. The solution seamlessly integrated with Satsuma’s existing systems and processes, without any compatibility issues.

Harris highly recommends Dot Compliance’s quality management software. “Our experience with Dot Compliance has been a very positive one,” she said. “The attention that is given to the customer and any issues that arise is very impressive.”

Satsuma’s success story showcases how well-implemented quality management software can transform operations, improve compliance, and drive growth.

Streamlining Multi-Site Operations: Milouda’s Success with Dot Compliance

THE CHALLENGE

Milouda Laboratories (Milouda) faced a significant challenge managing documents, training, and changes across multiple sites. With manual processes in place, tracking hundreds of protocols and procedures, training staff, and signing documents across different laboratories became increasingly complex and time-consuming. Having operations spread across various locations further complicated the need for a unified and accessible solution
to maintain consistency and streamline processes.

THE SOLUTION

Milouda partnered with Dot Compliance to implement an integrated electronic quality management system (eQMS) across its laboratories. Using Dot Compliance’s document management, change control, and training modules, the company centralized its compliance processes, allowing seamless document tracking, training management, and version control. The implementation covered three main sites, improving the consistency and accessibility of quality management processes across geographically dispersed locations.

Streamlining Quality Management Processes at CMP Pharma, Inc. with the Dot Compliance eQMS

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”.

VLE Therapeutic’s Digital Transformation Journey with Dot Compliance

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.