Calibration Manager 21 CFR Part 11 Electronic Records / Electronic Signatures

Blue Mountain is a pioneer in electronic records/electronic signatures for FDA 21 CFR Part 11 compliance, as the first company to integrate this capability into a calibration management software application.

• Enforce password expiration through the security options
• Track all electronic signature activity with the audit trail
• Configure the electronic signatures/electronic records settings to mandate use
• Maintain data integrity -- Calibration Manager is a closed system

Calibration Manager gives you the flexibility to implement according to your business processes and still meet the FDA's requirements. For example:

• Design rules allow you to determine who can sign and for what purpose (i.e. calibration technicians can only sign Calibration History records as an author)
• Different users can have different signing rights in different datasets
• Definable rules for use so different rules can be created for each type of record, Equipment Master, Equipment History and Measurement Data
• Precedence signing rules allow you to create a hierarchy with an incremental progression of required signatures. Records are signed by the correct person in the correct order, as required for regulatory compliance.
• Security options can be enabled to enforce password expiration
• Change control for paperless documentation of equipment records
• Configurable for a forced signature upon saving each record

Calibration Manager's automatic notification system can alert users via email to which records must be signed and which records have been signed.

21 CFR Part 11 compliant electronic signatures