Regulatory Compliance

Life Sciences companies as well as research laboratories and institutions must ensure that software, processes and reporting all meet standards for compliance with an array of regulatory authorities.

Persistent Advantage

• Team of experts with in-depth understanding of various compliance standards
• Experience in compliance enabling products of major industry players
• Reusable components for compliance implementation
• caBIG® Silver and Gold compliance implementation expertise
• Tech Team trained to handle sensitive data though regular HIPPA training and compliance engagements

Persistent Offerings

Persistent lab customers have relied on us for:

• 21CFR Part 11 compliant application development to ensure protection of records to enable their accurate retrieval throughout record retention period
• Use of secure, time stamped audit trails to track modifications of electronic records
• Validity of the source of the data input (e-signature)
• Automation of IQ, OQ, PV and RQ validations
•  HIPAA compliance to ensure
  • De-identification of mandated patient metadata
  • Authentication and authorization
  • Audit trails

cancer Biomedical Informatics Grid, caBIG and the caBIG logo are registered trademarks of HHS used in connection with the National Cancer Institute’s caBIG® program