A major contract analytical laboratory, AAIPharma Services/Cambridge Major Laboratories (AAI/CML), is expanding its use of IDBS Eâ€‘WorkBook across its US analytical laboratories and will be incorporating its Netherlands facility over the coming months.
AAI/CML is a contract development and manufacturing organisation (CDMO) that provides services for the pharmaceutical and biotechnology industries. The company offers services including API development and manufacturing, solid state chemistry, formulation development, analytical development, and testing services.
‘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.’
Eâ€‘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.
Dolan 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 organisation, regardless of geographical location.’
Laboratory analysts across the company use a number of validated templates to ensure standardised data input, reducing errors often associated with transcribing paper-based results. When the company was recently audited by the FDA, the paperless system was used to easily provide a full audit trail – essential in such a highly-regulated industry.
Michael Hampton, Vice President, North American Operations at IDBS commented: ‘AAIPharma Services/Cambridge Major Laboratories 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 organisation to complete more projects for clients faster, boosting revenue to better compete in today’s marketplace’ Hampton concluded.