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Quality and Compliance
Quality Policy
Good Products is committed to continual improvement and delivering the highest quality products to our customers. We strive to achieve the highest standards of quality, compliance and integrity through the software and services we deliver.
We have developed our Quality Management System to ensure a consistently high level of quality, which meets or exceeds all relevant regulations and standards.
Regulations and Compliance
Good Products founders and executives come from a regulatory and compliance background so that our development and build processes incorporate that extensive experience with the standards and guidelines, which include:
- US FDA: Title 21 CFR Part 11, Electronic Records and Electronic Signature
- US FDA: Guidance for Industry for Computerized Systems used in Clinical Systems
- US FDA: Title 21 CFR on Good Clinical Practices
- GAMP 5
- ‘Orange Guide’ Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002
- GLP Guidance
- GCP Guidance
- International Conference on Harmonization (ICH) Guidances
- Data Protection expectations as outlined in UK Data Protection Act 1998, EU Directive 95/46/EC and US HHS Title 45 CFR Parts 160 and 164