Quality & Compliance

From development through general product release, it's all about quality and compliance at OmniComm. This level of quality has been accomplished by leveraging the latest technological solutions and regulatory standards and regulations such as:

• Microsoft Technology Solutions
• US FDA: Title 21 CFR Part 11, Electronic Records and Electronic Signature
• US FDA: Guidance for Industry for Computerized Systems Used in Clinical Investigations
• US FDA: Title 21 CFR Good Clinical Practices
• US FDA Gl: General Principles of Software Validation
• International Conference on Harmonization (ICH). E6 Guidline for Good Clinical Practice
• Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL7)