GXP Compliance
GLP, GCP and GMP – or “GXP” – are general terms for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including pharmaceuticals, food research and manufacturing. EPL Archives (EPL) provides GXP compliant biorepository services and solutions that enable:
- Traceability – the ability to reconstruct the development history of a specimen, sample, drug or medical device; and
- Accountability – the ability to resolve who has contributed what to the development and when.
EPL’s computer systems used in our biorepository services and solutions must meet certain requirements, including:
- Secure logging – our systems information must be maintained in a secured environment so that it cannot be altered once logged, not even by an administrative user of the system;
- Auditing – our systems must be able to provide conclusive evidence in litigation cases, to reconstruct the decisions and potential errors that were made during the development or manufacturing of a medical device, drug or other regulated product;
- Audit archival – our systems must keep relevant audit information for a set period of time. Archiving requirements may span several decades, based on specific national or international regulations;
- Accountability – our systems track every piece of audited information, which must have a known author who has logged into the system according to established, secured access procedures; and
- Non-repudiation – audit trail information must be logged in a way that no user could say that the information is invalid or has been tampered with. One way of assuring this is the use of multi-tiered, password-controlled access.
Contact us today and put the EPL’s GXP compliance to work for you.
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