Leading Contract Development and Manufacturing Organization (CDMO) boosts number of users in line with company growth
Boston, US & London, UK, March 8, 2016 – AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. (AAI/CML), now known as Alcami, 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 incorporating its Netherlands facility in the coming months, to support further company growth. 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 operations, 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 ultimately, 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 electronically 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 manufacturing 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 purposes.
AAIPharma Services Corp. / Cambridge Major Laboratories, Inc. expands IDBS’ E-WorkBook platform across global analytical sites
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 American 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 collaboration 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.”
IDBS is a leading global provider of advanced software for research and development (R&D) organizations to securely capture, manage, share and exploit structured and unstructured data. Our technology and domain expertise enable users to link data to data, data to people, and people to people, to drive innovation, achieve faster time to market and improve margins. Our diverse customer list includes R&D driven international companies in pharmaceuticals, biotechnology, agricultural sciences, chemicals, consumer goods, energy, engineering, food and beverage, and healthcare.
Founded in 1989, IDBS is headquartered in the United Kingdom with offices across Europe, Asia and the United States. IDBS remains a privately held company employing over 250 staff across the world and serving over 50,000 researchers in 25 countries – including over 80% of the top twenty pharmaceutical companies.
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About AAIPharma Services Corp. and Cambridge Major Laboratories, Inc.
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. have joined to form a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With seven sites across the globe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (solid dose and parenteral), packaging, and stability services. Contact us for all of your drug development and manufacturing needs at www.aaipharma.com and www.c-mlabs.com.