Archiving

Good Laboratory Practice – GLP

Why GLP?

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.

Our Solution for GLP-compliant Archiving 

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.

Our 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 and certified in line with the German Chemikaliengesetz, EU Directive 2004/9/EC and OECD Principles of GLP. Click here to view the recent statement of GLP compliance issued by the Landesamt für Umwelt, Mainz, Germany. 

For the Study Sponsors

SCC can archive your GLP raw data directly after the finalisation of the study report. Alternatively, we can handle the transfer and archiving of your GLP raw data after the agreed archive period at the CRO has expired.

For CROs

If your archive space is used to full capacity, SCC can take care of your or the study sponsor’s GLP raw data short or long term.

Although there are various domestic minimum archiving periods, we advise our customers to archive GLP raw data of a study as long as they plan to re-register the active substance or product. If you have any questions, please don't hesitate to contact us. 

Regulatory Archive – EDDMS

We offer a unique database system for all your  regulatory archiving needs – the Electronic Document and Dossier Management System (EDDMS).

EDDMS

The reliable archiving of data, study reports, submissions and corresponding documents has become a complicated and complex task in the regulatory world requiring transparency, quick access and the accuracy of the entries and associated information.

For more than thirty years, since SCC's establishment in 1989, the data management and archiving of client information has been a top priority. Starting out with a simple database system, SCC has continually improved and refined this data management system to its current status, an exclusive data management and archiving software – EDDMS.

EDDMS can be used for all regulatory submissions: for chemicals (REACH), plant protection products, biocides, pharmaceuticals, consumer products, or any other type of product. This flexible system allows you data access on individual PCs, computer networks, or on a global scale. The administration of the data allows for a complete overview of what kind of data is in the archive, to whom it was submitted, and when.

EDDMS is an optimal solution for your data management, offering the following features:

• Data administration, including the direct viewing of integrated electronic files resulting in cost and time savings.
• Data presentation, allowing as well the retrieval (export) and presentation of the archived data in any format to fit the specific requirements of regulatory authorities.
• Tracking of studies, providing submission information and allowing for tracking through the administrative channels within the regulatory authorities.
• Comprehensive search and archiving functions, and the use of SCC's in-house developed indexing system, adapted to the needs of the regulatory world.
• Study compensation and multiple user needs can be easily fulfilled for task forces and consortia. The EDDMS client manager allows individual definition of the access rights. Complete records or selected data boxes can be hidden or shown for respective users.
• Simplified compilation of electronic dossiers (e.g. CADDY).