Electronic Signatures & Multi-Level Approval

From www.WinLIMS.info

Within the FDA-regulated industries 21 CFR Part 11 [[1]] compliance is an essential initiative. This regulation establishes the criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures. The intent of 21 CFR Part 11 is to ensure data security, data integrity and traceability. This set of security requirements is also a need within many non-regulated laboratories that are eager to ensure the highest possible level of data integrity.

In order to comply with CFR Part 11 for data security:

• Access to electronic records must be restricted to authorized personnel only.
• Electronic Signatures must be linked to the corresponding e-records, and include the signer’s printed name, the date and time and the significance of the signature, such as approval or rejection.
• Integrity is ensured by preventing changes to data and enabling the reproduction of original results by linking data and outcomes.
• Traceability must be guaranteed by a secure, computer-generated audit trail.
• Retrieval of stored data must be available for the same length of time as equivalent paper records — up to 10 years, and in some cases, even longer.

The combination of standard WinLIMS functions and the optional Electronic Signature module is offered by QSI to accommodate all of these CFR Part 11 requirements. The Electronic Signature module provides a flexible means for allowing you to define the events that require electronic signature by incorporating your company’s interpretation of the events that requires an electronic signature. The electronic signature can be entered via keyboard or via a biometric reading device.