FDA 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered to be 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 and audit trails.  While no software company can offer complete FDA compliance, Qualtrax's FDA Compliance Module equips customers with the guidelines, test sheets and services necessary to help a company get its Qualtrax system validated by the FDA. 

Technical Controls
Qualtrax meets FDA 21 CFR Part 11 technical requirements with the following features:

• Electronic Records:  Qualtrax provides complete management of electronic records, including tracking of all revisions, approvals and provides time and date stamps.  Records are never removed from the Qualtrax system, rather they are retired and can be accessed with the appropriate permissions for audit purposes.
  
• Audit trail: Qualtrax records an audit trail of all the actions taken on documents, tests, workflows, users and groups.
  
• Electronic Signatures: Qualtrax forces users to reenter their login name and complex password for any documents that require a legally binding electronic signature.

Procedural and Administrative Controls
Qualtrax provides tools and services to help implement the necessary procedural and administrative controls for FDA compliance.  Qualtrax’s FDA Compliance Module includes:

• Site Acceptance Test: Prior to the validation process, the Site Acceptance Test is conducted by Qualtrax to determine if the software installation is operating according to specifications. Validation presents clear and convincing evidence that the system functions in a manner consistent with the particular installation information noted in the Validation Workbook.
  
• Validation Protocol Workbook: This workbook reduces the time and cost associated with validation of the system.  The workbook serves as a template for compliance officers to use as a means of testing usage of Qualtrax for the control of electronic records and signatures.
• Validation Final Report: This report is in template format and is a summary of validation test results and open issues. The document records deviations, recommendations and conclusions.

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