GMP Records Library Management
A large, established company came to Infotrieve seeking to completely outsource its on-site Good Manufacturing Practice (GMP) records libraries, which require maintaining impeccable records for drug manufacturers, enabling a complete history of a batch to be traced, typically for regulatory purposes.
Infotrieve assumed management of the client's GMP records libraries, understanding that adhering to strict quality and process guidelines is mandatory to avoid harsh regulatory fines. Infotrieve implemented and maintained documentation practices and retention polices and assured completeness, accuracy and legibility of all GMP documents along with daily self-assessments to measure efficiency.
With GMP guidelines in mind, Infotrieve supplied on-site staff to maintain and update library catalogs and conference databases for the client. We also organized metadata in networked information systems using traditional and emerging metadata schemas, including original and copy cataloging and document indexing. The cataloging staff utilized its knowledge and expertise with various integrated library systems; proficiency in MARC and other metadata schemas; classification schemas and controlled vocabularies, including the Library of Congress and the National Library of Medicine DDC; and cataloging support tools such as Classification Web, Cataloger's Desktop and OCLC Connexion.
The client continues to benefit from Infotrieve's staffing and operation of its scientific libraries. Our library solutions combined the best elements of staffing and technology to produce excellent results for the client.