PharmaMar streamlines operations with TrackWise®

As a biopharmaceutical company tasked with delivering safe, effective cancer treatments for thousands of patients worldwide, PharmaMar must adhere to strict compliance guidelines like the Good Manufacturing Practices (GMPs) regulation, as well as many additional directives for the protection of employees and the environment. The company also maintains rigorous internal standards for quality management and continually looks for ways to improve quality across the entire organization. Traditionally, PharmaMar used a paper-based system to track and report on the quality management and regulatory reporting of its CMC (Chemistry, Manufacturing & Control) operations. Everything from deviations, investigations and CAPAs (Corrective and Preventive Actions) were paper files that were transferred from one department to the other and filed away. Reports would get lost within the organization or be filed improperly, and collecting and reporting on information from various parties took considerable time and effort. Given the increasingly stringent global regulatory environment for life sciences companies, PharmaMar knew it had to find a more efficient, standardized way to track processes related to CMC quality management and collect data for easy reporting to regulatory authorities. In addition to a paperless system, it also needed a solution that would seamlessly scale to meet the evolving needs of its rapidly growing global operations.

Rather than undergo a long, multivendor evaluation, PharmaMar knew right away that it wanted to implement TrackWise quality management software. José Luis Ortega, quality unit director at PharmaMar was familiar with TrackWise software and knew of the strong cost-to-benefit ratio. The remainder of Ortega’s team took little convincing as well, since many of them had heard about TrackWise’s sterling reputation and proven track record of implementations at life sciences institutions across the globe.

While initially concerned with employee reaction to transitioning to an electronic system and the level of training that would be required, PharmaMar found the transition to be easy. The dedicated TrackWise professional services staff worked closely with the PharmaMar team to ensure a high level of comfort and usability. Given the time-savings and reporting benefits, as well as having easier access to timely information, PharmaMar employees welcomed TrackWise with open arms.

“TrackWise enabled us to implement new workflows associated with quality processes, track and manage activities and commitments, analyze trends and improve quality across the entire organization,” said Ortega. “We are convinced that the cost-to benefit ratio of the TrackWise implementation is extremely positive for companies like PharmaMar, and we look forward to reaping the benefits that will continue to come from using the system.”