For most studies conducted in a regulatory context, apart from scientific validity and guideline conformity, the execution of the study under Good Laboratory Practice (GLP) is mandatory for its acceptance by the regulatory body designated to evaluate the dossier. The GLP compliance of a given study can only be maintained over the regulatory process, if the continuous storage of the raw data under GLP is ascertained. Doubts about the adequate conduct of the study or storage of its raw data will result in the immediate revocation of the GLP status. All regulatory bodies involved will be informed and will not rely on this study any longer in their evaluation, resulting in unforeseen data gaps that will jeopardize your timely registration.
We offer a complete GLP-compliant archiving concept for all regulatory needs to the benefit of all our clients. We act as your European or worldwide central archive for GLP-compliant storage. The GLP archive management system (GMS) allows direct access for authorised personnel to all relevant information of the archived data. A complete audit trail of all entries or changes of records is guaranteed. The risk of loss of data is eliminated through regular back-ups of the database. The electronic system monitors all deadlines entered.
The archives are fully equipped according to official requirements and allow storage at ambient temperature, ambient within a guaranteed temperature and humidity range, as well as refrigerated and deep frozen conditions. All facilities are integrated in a monitoring system, which is activated and monitored 24 hours per day and 7 days per week.
As an independent test site in the national GLP Compliance Programme, we are inspected on a regular 3 year basis. Our contract archive was inspected on 24 October 2018 and the statement of GLP compliance according to the German Chemikaliengesetz, EU Directive 2004/9/EC and OECD Principles of GLP was issued on 18 February 2019 by the Landesamt für Umwelt, Mainz, Germany.