MEDICAL DEVICE
When compared to other FDA regulated environments, Medical Device manufacturers require a unique approach to validation. From designing Validation Master Plans to execution of IQ/OQ/PQ’s, we have deep experience in all forms of validation across all business areas within FDA regulated environments.
- Validation Master Plan development. A well-designed Validation Master Plan is the critical foundation for your validated environment and serves as a principal means of showing the FDA that you are in control of your production environment.
- Process and product validation based upon our product, manufacturing, statistical, and compliance expertise
- Computer Systems Validation (CSV)
- Manufacturing equipment and laboratory equipment validation
- Facilities and Utilities
- Customized IQ/OQ/PQ protocol development and execution
- Device Verification and Validation
- Deviation remediation
Computer Systems Validation
Maetrics™ provides complete Computer Systems Validation (CSV) services including up-front documentation development (URS, FRS, DDS, FAT), software testing, and complete validation packages for computer systems, software, and equipment such as:
- Enterprise Resource Planning (ERP)
- Laboratory Information Management Systems (LIMS)
- Change Management Systems (CMS)
- Maintenance Management Systems
- Corrective Actions/Preventative Actions (CAPA)
- Training Tracking Systems
- Deviation/Issue/Event Tracking Systems
- IT network infrastructure and security
- Document Management Systems
- Manufacturing Execution Systems (MES)
- Programmable Logic Controllers (PLC)
- Supervisory Control and Data Acquisition Systems (SCADA)
- Embedded firmware
- Distributed Control Systems (DCS)
- Records Imaging Systems
- Software quality assurance and testing services
- Spectrophotometers
- Total organic carbon analyzers
- HPLC, GC instruments and others
- Process chromatography
- Electron microscopes
- Lyophilizers
- Autoclaves
- Depyrogenation, sterilization, barrier pass-through, and curing ovens
- Barrier isolators
- Fluid bed dryers
- Fermentors
- Pasteurizers
- Mills and granulators
- Washing equipment
- Filling and mixing equipment
- Transfer systems
- Packaging equipment and lines
- Weigh dispense systems
- Pumps
- Packaging equipment
