Service Content
Comprehensive and continuous validation services are provided for activities in the medical device and in vitro diagnostic medical device sectors. Validation is much more than just stating what the outcome of a process will be and ensures that processes, equipment, software and facilities are appropriately qualified and that validation packages meet regulatory requirements.
Guidance process, product and software validation studies
Validation, a key component of compliance, requires a comprehensive knowledge of regulations and how they should be interpreted. Technical support is provided for all types of validation, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), and relevant requirements in global markets are addressed.
We help our customers design the critical foundation for their Validation Master Plan.
Validation services overview
Validation Master Plan design, oversight of test methods, packaging, sterilization, design, shelf life testing and cold chain transportation, as well as the following services:
Manufacturing Equipment Validation
Laboratory testing equipment
Aseptic/sterile processing
Water for injection systems
Process chromatography equipment
Injection molding equipment
Cleaning Equipment Validation
Filling and mixing equipment
Transfer systems
Part washers and autoclaves, CIP/SIP
Weigh distribution systems
Pumps
