PROCESS TECHNOLOGY CQV

We strive to eliminate unnecessary CQV redundancies by utilizing our manufacturing technology expertise to streamline the validation process.  Our experience allows us to generate more robust and effective test scripts, resulting in reliable fully validated system.   

• MASTER VALIDATION PLAN: As part of the MVP, strategic steps are highlighted based on industry's best practices

• STRATEGIC VALIDATION: Each of the product and/or process Critical-to-Function requirements are listed and then added to a Traceability Matrix to assure completion throughout the process. 

• USER REQUIREMENTS:  Our approach advances and Leverages each step as possible.  The User Requirement Specification (URS) includes the voice of each customer and product requirements and align with technology.  

• EQUIPMENT DESIGN:  We work with the Original Equipment manufacturers (OEM) and components manufacturers to assure capturing in the design their tolerances and capabilities. Equipment Design Reviews assure OEM understands User Requirements and aligns designs as needed. 

• FACTORY ACCEPTANCE TEST(FAT):  We strive to execute full GMP FAT documents, leveraging as possible based on approved MVP, reducing implementation timeline.

• EQUIPMENT OPTIMIZATION: Each process is fully Characterized, including cost effective Design of Experiments (DOE) and optimized Critical-to-Function (CTF) parameters. Success is measured using Overall Equipment Effectiveness (OEE). In most cases equipment characterization phases start prior to FAT and are finalized prior to Operational Qualification.     

• INSTALLATION / QUALIFICATION (IOQ):  We provide expertise during equipment rigging and  installation including Facilities Utilities Availability.  Our team develops all necessary documents, including Work Orders using your Site's QMS and assure work is compliant.

• PROCESS QUALIFICATION (PQ):  We are hands-on during the Technician's and Train-the-Trainer Certifications to assure expertise during the PQ execution, and proper hand-shake with the site Manufacturing and Quality teams. 

• COMPUTER  SYSTEM VALIDATION (CSV): Profits Engineering partners with a selected CSV professionals to complete any computer system validation requirements  

WE ENSURE cGMP AND TRACEABILITY THROUGHOUT THE ENTIRE PROCESS!