From implementation, through FDA submission and all phases of clinical research, to the eventual marketing of your drug or device, Bright's Quality Management team is focused on every aspect of your program. Bright's Quality Management methodology is rooted in developing and maintaining a consistent documentation plan that keeps all the disparate groups involved in your project on the same page throughout. When each branch of your team has ready access to necessary data in a format that everyone involved understands, communications become streamlined and your entire organization and your vendors are fully prepared for audits, changes in scope, or any deviation from expected results.
With Bright's Quality Management team in place, your “left hand” will always be speaking to the “right hand” in a language you all understand fluently.
Bright offers the following Quality Management Services:
- Quality Management Plans
- Metrics for Performance and Compliance
- Independent Data Auditing
- 21 CFR Part 11 Compliance
- GLP, GMP, and GCP Consultation, Training, and Auditing
- Standard Operating Procedures
- Regulatory Master File Review
- Preparation and Facilitation of Third Party Audits
- Site GPC Audits
- Vendor Qualification Audits