Validation and Quality Management
Commissioning and Qualification
ProEx Engineering have extensive experience in the commissioning and qualification of complex equipment and systems in the pharmaceutical, bio pharmaceutical, medical device and semi conductor industry. Our services include:
- Master Validation Plan
- URS generation
- SDS, FDS and HDS generation
- Process Development and Characterisation
- FAT protocol generation and execution
- SAT
- IQ
- OQ
- PQ
- Traceability Matrix
- SOPs and Machine Instructions
Quality Management
ProEx Engineering has a team of Quality management specialists that provides a consultancy service to our clients in the Pharmaceutical, Biopharmaceutical, Medical Device and Food and Beverage Sectors. Our services include:
- Regulatory Filing and QP services
- Audit Preparation and Mock Audits
- Preparation for manufacturing licence submissions
- Development and delivery of quality training programmes
- GMP and Operational excellence assessments
- Quality risk assessments and reporting
- Support for developing and implementing quality management system
- Quality impact assessments
- Quality assessment for changes to equipment, facilities or process
Our Mission
ProEx Engineering highly values our clients’ needs for safe, reliable, and operationally efficient designs through cost-effective engineering and project management services in a responsive, dynamic, and efficient way. Our Principals have built their careers understanding this truth, and have developed trusted, long-lasting relationships within the industry by conducting our business with integrity, honesty, and hard work. The ProEx Engineering Mission Statement is to provide responsive, safe, and trusted solutions to our clients with the highest-quality, innovative, cost-effective engineering, design, and construction management services in the Life Science Industry.
