Regulatory compliance of CTL Software
Regulated industries are required to use validated electronic records and signature systems equivalent to paper records and handwritten signatures to assure data quality and integrity. This mandate is defined in U.S. Food and Drug Administration (FDA) 21 CFR Part 11 and its European counterpart, EU Annex 11 regulations.
CTL’s software is developed in house following these requirements (learn more).
CTL’s Software products specifically address all components of Part 11.10 mandates (the links elaborate on how our software addresses each requirement):
- Copies - Part 11.10 (b)
- Record Retention - Part 11.10 (c)
- Data Protection and Access Control – Part 11.10 (d,f,g)
- Audit Trails - Part 11.10 (e)
- Data Integrity - Part 11.10 (g,h),
- Authority checks -Part 11.70
- Documentation, Validation of Systems - Part 11.10 (a)
CTL offers IQ and OQ for its regulated customers. Our ImmunoCompliance™ Package includes a three-tier offering.