GHP April 2016

ghp April 2016 | 39 Innovation & Technology AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. Expands IDBS’ E-WorkBook Platform Across Global Analytical Sites The expansion complements all six of AAI/CML’s US sites which have been using E-WorkBook for three years, moving away from paper-based processes to streamline sample analysis and encourage collaboration. “E-WorkBook is a critical part of our business op- erations, enabling us to harmonize documentation practices using electronic, automated and integrated templates, thereby increasing the speed with which we can test samples. We rely on the efficiency the platform delivers to turn around our analyses, and ul- timately, deliver results to our clients faster,” explained Ted Dolan, Chief Operating Officer for AAI/CML. “Our previous paper-based approach required analysts to hand off test packages for quality review or ship packages between sites, causing unnecessary delays in review and final data write-up.” He added, “As we have grown and become an integrated full service custom CDMO, it is in our best interest to capture and store all test results electron- ically so they can be shared in real-time across the organization, regardless of geographical location. The platform has been a welcome change with our US teams and implementing it in our Netherlands facility will complete the system integration.” E-WorkBook enables AAI/CML to record and share data from its API custom development, testing and manufacturing, analytical development and testing and drug product development, testing and man- ufacturing teams, on a single platform across the company’s seven sites. This approach saves time, boosts productivity, streamlines the review process and ensures quick access to data for compliance pur- poses. Laboratory analysts across the company use a number of validated templates to ensure standardized data input, reducing errors often associated with transcribing paper-based results. When the company was recently audited by the FDA, it was able to easily provide a full audit trail, which is essential in such a highly-regulated industry. Michael Hampton, Vice President, North Ameri- can Operations at IDBS commented, “AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. has been through a significant transformation, from a paper-based system to an electronic environment and it is certainly seeing the benefits. Giving laboratory analysts access across global sites ensures data can be shared quickly and efficiently, boosting collabora- tion opportunities and ensuring compliance in today’s tough regulatory arena. Above all, a reduction in timeline duration enables the organization to complete more projects for clients faster, boosting revenue to better compete in today’s marketplace.” For more information, please visit or follow the company on Twitter @IDBSsoftware. AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. (AAI/CML), a leading provider of contract manufacturing and development services for the pharmaceutical and biotechnology industries, has expanded its IDBS E-WorkBook platform across analytical laboratories in the United States and will be incorpo- rating its Netherlands facility in the coming months, to support further company growth.