Parameter Generation and Control provides regulatory compliance and validation services to FDA regulated industries. Parameter provides the necessary service based on project requirements using the applicable cGMP’s to ensure compliance. We provide validation support at any level, either as augmented support for part of a project or a complete turn-key solution.
Our Advantage: A unique blend of technical expertise, regulatory compliance insight, and practical hands-on operating experience.
Validation & Compliance Solutions
Parameter’s Validation Services Group can provide turn-key cost effective solutions to your validation and compliance challenges. Whether it is the challenge of setting up a validation or qualification program or an emergency response to a critical compliance situation, our Validation Services Team will respond to your needs with proven resolution, expertise and confidence. With Parameter’s Validation Services Group you will receive the highest quality service conducted with the strictest confidentiality.
Parameter provides equipment validation services ranging from individual bench top equipment to large scale Pharmaceutical & Biotech manufacturing plants including utilities.
- Policy and Procedures Deployment
- Validation Gap Assessments
- Customized Validation Master Plan Development
- Project Management
- Protocol Development and Execution
- Documentation Management
- Design Qualification
- Change Control
- URS, FRS, IQ, OQ, PQ, and Final Reports
- Factory and Site Acceptance Testing (FAT, SAT)
- Start-Up and Commissioning
- Installation, Operational, and Performance Qualification
- Equipment, Facilities, and Utilities Qualiﬁcation
- Protocol Execution
- Process Validation
- Laboratory System Validation
- Stability Chamber Qualiﬁcation
- Revalidation and Re-qualiﬁcation
- Validation Life Cycle Methodology
- Final Report Development
- Standard Operating Procedures (SOP) Development and Implementation