No matter how well a system performs, if your data or processes are not compliant with regulatory standards, your investment is put at great risk.

21 CFR Part 11

Compliance with FDA and similar regulations places a substantial burden on your organization. CERF meets your regulatory obligations through measures including extensive security controls, automatic audit trails, version control, digital-signatures, and PDF reporting of data for recordkeeping. Rescentris’ staff has expertise in ELN implementation and can assist you in deploying a secure and compliant ELN environment.

Audit Trails

CERF logs every action that creates, modifies, or deletes a record, as well as each access to resources stored on the CERF server. A complete audit trail may be established for document version history, digital signatures, and controlled documents. Each user and each resource in CERF is uniquely identified. Audit trails may be constructed by resource (e.g., document) to determine access to the resource, by user, to determine resources accessed by a user, and by the actions taken on a resource.