Clincase’s compliance efforts are focused on enabling our partners to meet their obligations under FDA 21 CFR part 11 and to follow the guidelines as set out in EU GMP Annex 11. Clincase is also readily configured to support our clients and partners with Good Clinical Practice (ICH-GCP) and overall compliance strategies.
Comprehensive Quality Assurance and Quality Management
We follow our own comprehensive quality assurance and quality management program covering the relevant aspects of legislation relating to EDC software and computerized systems for clinical trials. We are also in compliance with ICH-GCP and with the German Federal Data Protection Act (Bundesdatenschutzgesetz).
All of our software is designed, implemented and tested using an agile-based approach and software development life cycle (SDLC) methods. Verification and validation procedures are embedded into the software development lifecycle.
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