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Meeting today’s FDA Compliance requires a full-team commitment to quality assurance. This collaborative effort must be supported by processes, procedures, and software that contribute to continuous improvement practices required by the FDA.  Specific to complying with 21 CFR Part 11, we are proud of how our product is an excellent solution.

Meeting Today's FDA Compliance

CFR stands for “Code of Federal Regulation” and 21 CFR Part 11 specifically defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records. Think about it, it isn’t enough to simply have a software solution in place when critical compliance is hanging in the balance. The software must be proven to support traceability, accountability, and reliability of data — which includes associated sign offs.

Good news! Qualtrax is designed with the necessary Technical controls for 21 CFR Part 11 compliance.

Our closed system provides robust electronic document and record control, revision tracking, electronic signatures, and audit trails.  While no software vendor can offer a certified FDA compliant solution, since it is the responsibility of the user to implement the Procedural and Administrative Controls to ensure overall Part 11 compliance, we  do offer services and tools to help with this process.

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

Electronic Records

Qualtrax provides complete management of electronic records, including revision and approval tracking with 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 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 demands users re enter their login name and complex password for any documents that require a legally binding electronic signature.

Qualtrax provides tools and services to help implement the necessary procedural and administrative controls for FDA compliance. The FDA Compliance functionality 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 Protocol Workbook

This workbook reduces the time and cost associated with system validation. The workbook serves as a template for compliance officers to test usage of Qualtrax for electronic records and signatures control.

As we have customers under the purview of the FDA and CFR requirements we understand these technical capabilities, and procedural & administrative controls are necessary and mission-critical. We are proud of how our product positively impacts organizations making critical contributions to society, and we are pleased to be part of their compliance solutions.

Categories: Product, Public Health

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