Since 2005, PV has assisted several large (Fortune 500) companies, foreign subsidiaries, and smaller medical device companies with qualification of facility and manufacturing equipment, verification and validation of the manufacturing processes.
Performance Validation professionals plan Medical Device Validation projects, small and large, from defining equipment requirements and installation qualification to final assembly process and software validation. We work to find a cost-effective, high-quality solution for your validation needs while achieving regulatory compliance.This is achieved by working with you and your Subject Matter Experts (SMEs) to not only understand your products, equipment, and processes, but also understand any company-specific requirements you might have. We bring our knowledge and experience in medical device manufacturing validation to drive documented justification for focused testing and streamlined document development and execution. This controls the validation cost and time required for your project without sacrificing quality or compliance.
Verification and Validation Project Planning Activities/Deliverables Include:
Validation Change Plans for Upgrades to Existing Production Lines
Participation in Risk Analysis Development
Project Management (including Expense, Project, and Milestone Management)
Performance Validation professionals understand the need to clearly define and document equipment requirements that are reasonable, objective, and provide clear acceptance criteria which, when tested
and accepted, leave you with qualified equipment that does what you need it to!
Our professionals work with you throughout the equipment qualification phase and provide high-quality user requirement documents and functional specifications for your custom, complex, or simple off-the- shelf equipment. Using these documents, we develop and provide Installation Qualification protocols for your review and approval. These IQ documents ensure your equipment or system not only meet the requirements, but also function as intended in a validated state. This can be done by not only checking that calibration and preventative maintenance procedures are in place, but that they are accurate and appropriate.
Types of equipment we have qualified include:
Vision Systems & Automated Inspection equipment
Manual and automated presses
Custom Fixtures used in Manual or Automated Processes
Complex, Automated Equipment with Custom Software
Custom, Complex Equipment
Performance Validation professionals not only develop and execute high-quality Operational and Performance Qualification protocols, we can also assist in the Design of Experiment and testing strategy.
We work with your experts to help understand, document, and test your manual, automated, and special processes to ensure your development and process is compliant.
Types of Processes we have Validated:
Adhesive Cure Time
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