Long before any pharmaceuticals or medical devices reach the patients or the healthcare professionals who depend on them, the systems, equipment, processes, and methods behind developing, producing, and testing them must be validated to ensure they function as intended. Maetrics has expertise in all areas of validation, including Information Technology systems; Facility/Utility/Equipment qualification; Product/Process/Methods validation; Cleaning validation and Cold Chain qualification.
As a global leader in life sciences consulting, Maetrics provides comprehensive and ongoing validation services for activities and operations in the biotech, pharmaceutical, medical device, and diagnostics sectors. Validation means much more than just specifying what the outcome of a process will be, and Maetrics will ensure your processes, equipment, software, and facilities are appropriately qualified and that validation packages meet regulatory requirements.
Guiding Process, Product, and Software Validation Efforts
As a crucial component of compliance, validation requires a thorough knowledge of the regulations and how they’re meant to be interpreted. Maetrics will provide validation guidance for all forms of validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and as a global organization we can address the relevant requirements across the world markets.
We also assist clients in designing the critical foundation for their validated environment, the Validation Master Plan. The Master Plan is one of the principal means of showing regulatory bodies that you’re in control of your production environment.
An Overview of Maetrics’ Validation Services
Maetrics’ validation services include designing the Validation Master Plan, oversight of test methods, packaging, sterilization, design, shelf life testing, and cold chain shipping, as well as the following services:
Computer Systems Validation (CSV)
Complete validation packages for computer systems, software, and equipment including:
- Enterprise Resource Planning (ERP)
- Laboratory Information Management Systems (LIMS)
- Change Management Systems (CMS)
- Learning management systems
- Maintenance management systems
- Corrective Actions/Preventive Actions (CAPA) and Complaint Management Systems
- 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
Manufacturing Equipment Validation
- Laboratory testing equipment
- Aseptic/sterile processing
- Water for injection systems
- API manufacturing
- Process chromatography equipment
- Injection-molding equipment
Cleaning Equipment Validation
- Filling and mixing equipment
- Transfer systems
- Parts washers and autoclaves, CIP/SIP
- Weigh dispense systems
Facilities and Utilities Validation
- Utilities including HVAC, compressed air, water systems, and many others
- Equipment commissioning, qualification, and validation
- Customized IQ/OQ/PQ protocol development and execution
- Temperature and environmental mapping
- Factory Acceptance Testing (FAT) & Site Acceptance Testing (SAT) execution
Have a Question?
Contact us to learn more & find out how Maetrics can solve your regulatory or compliance issues.