We can work as support on small tasks, provide a resource to participate as part of your team, of put a team together to address a major project.
Some examples of projects include:
Gap assessments to verify that facilities are in compliance with general GMPs, 21CFR11, Annex 11, GAMP, and good practices for calibration, validation, maintenance, change control, CAPA, training, etc.
We can provide you a concise report, and you can decide what (if anything) you would like to address and how.
- Developing User Requirements, System Specifications, Factory or Site Acceptance Tests, Validation Protocols and Reports.
- Developing Standard Operating Procedures (SOPs) that you can use to support company objectives including engineering, calibration, maintenance, validation, 21CFR11 and/or GMP compliance, and many others.
- Creating/updating technical documents such as workflows, software code printouts, system architecture drawings, electrical schematics, floorplans, process drawings, material flow drawings, piping and instrumentation (P&ID) drawings, etc.
We have worked on several projects from conception to completion of qualification for GMP use. We have also worked on small, piecemeal contributions. Below are a few examples:
- Implemented 21CFR11 compliant system for GMP sterilizer control/reporting system including project management, design, documentation, testing, and validation for GMP use.
- Performed validation of DeltaV and Rockwell/Allen Bradley systems for process control of pharmaceutical, chemical and bioreactor, utility and equipment control systems.
- Modified for GMP use and validated building control systems including Johnson Metasys, Teletrol, Distech, and Siemens controllers.
- Several small projects performed for lesser known control system validation for GMP use, including E-signature and 21CFR11 compliance.
- Validation of multiple facility construction, HVAC and BMS systems including a variety of manufacturers.
- Validation of multiple utility systems.
- Management of GMP construction projects.
- Management of RCA program for GMP drug production issues including statistical analysis.
MEDICAL DEVICE DEVELOPMENT/VALIDATION
- Contributor to multiple medical device qualifications and submissions.
- Evaluated/proposed human centered design improvements to reduce error rates.
- Developed and validated multiple database systems for GMP use.