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Meeting FDA 21 CFR Part 11 FDA 21

CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Qualtrax is designed with the technical controls necessary for 21 CFR Part 11 compliance. The closed system provides robust electronic document and record control, revision tracking, electronic signatures, audit trails, and computer system validation.

Technical Controls

Electronic Records

Qualtrax provides complete management of electronic records, including revision and approval tracking with time and date stamps. While records can be retired or deleted, those records are never removed from the Qualtrax system and can be accessed with the appropriate permissions for audit purposes.

Audit Trail

Qualtrax records audit trails providing details about changes made during the document life cycle, including the date/time and user profile. Audit trails for tests and trainings capture the date/time the test was taken, expiration, pass/fail score, cancellation, and incomplete tests. Audit trails for workflows include date/time each step was processed as well as capturing the responsible user and groups per step.

Electronic Signatures

Qualtrax requires users to reenter their login name and complex password for any record updates that require a legally binding electronic signature.

Procedural and Administrative Controls

Silver and Gold Validation Platforms

Qualtrax offers two validation platforms, which are designed to cover the Installation Qualification and Operational Qualification required for FDA computer system validation. You can find out more about the value of the validation platforms here, including the differences between Silver and Gold.

Long Term Support & Test Site

Long Term Support allows for annual upgrade, on a fixed schedule, while still receiving any hotfixes throughout the year.  A Test System is included for validation and training purposes.

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