Is Your CQV Process
Optimized for Success?
Partner with Puresynk to streamline your Commissioning, Qualification, and Validation processes. Discover seamless project management with our expert consulting and staffing solutions. Start your journey today
Expert CQV Solutions with Puresynk
At Puresynk, we turn our passion for CQV (Commissioning, Qualification, and Validation) into your advantage.
Our team is dedicated to being your go-to resource for every step of your CQV needs—whether it’s planning, documentation, testing, or start-up.
We work closely with engineering, validation, logistics, manufacturing, and regulatory teams to provide a comprehensive and transparent progress dashboard.
This ensures you have real-time visibility into your project’s schedules and budgets, making the entire process seamless and efficient.
Validation and Commissioning CQV
Utilities, systems, and equipment (FUSE) through our risk-based commissioning and qualification
- User Requirement Specifications
- Function Requirement Specifications
- Detailed Design Qualification
- Critical Aspect Risk Assessments
- Facility Validation Master Plans
- Installation Verification/Qualification
- Operational Verification/Qualification
- Cleaning/Steaming Cycle Development
- Performance Verification/Qualification
- Validation Master Plan
Installation and Commissioning
Ensures your production processes, systems, and equipment are designed and installed as specified and function as intended
- Design Reviews
- Factory Acceptance Tests (FAT)
- Receipt and Inspection
- Site Acceptance Testing (SAT)
- Commissioning Protocol/Checklists
- Punch List Management
Process Validation
Ensures and provides documented evidence that processes within their specified design parameters are capable of repeatedly and reliably producing a finished product of predetermined quality
- Process Design
- Process Performance Qualification (PPQ)
- Process Verification
- Analytical Method Validation
Cleaning Validation
Cleaning validation analysis to support pharmaceutical production is critical to reducing the risk of drug product contamination, ensuring that process and processing equipment are suitable for pharmaceutical manufacturing. Potential contaminants include residues of the active pharmaceutical ingredients (APIs), API degradation species, or residues from the cleaning process such as detergents or solvents.
Cleaning validation analysis to support pharmaceutical production is critical to reducing the risk of drug product contamination, ensuring that process and processing equipment are suitable for pharmaceutical manufacturing. Potential contaminants include residues of the active pharmaceutical ingredients (APIs), API degradation species, or residues from the cleaning process such as detergents or solvents.
Validation Protocols and GxP
Documentation Templates
Our curated validation protocols and templates, crafted by seasoned experts, eliminate the need for extensive 150-200 hour drafting processes for each Validation Protocols, URS, RA, and other GxP forms. We offer solutions customized to your specific requirements, ensuring compliance with standards and regulations with GxP document support to meet your tight deadlines.
- IQ, OQ Qualification Protocol for Manufacturing Equipment
- IOQ Qualification Protocol for Laboratory Equipment
- Utility Qualification Protocols
- Performance Qualification Protocols (PPQ)
- Computer System Validation (CSV/CSA) protocol
- Commissioning Qualification protocols
- Calibration and Maintenance reports
Computer System Validation (CSV) Services
We take the regulatory principles of CSV guidance and establish benchmarks for each system or asset against safety, quality, and system integrity using risk-based validation approaches.
- Standard Validation Templates – We provide a standard suite of Software Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report.
- CSV/ CSA expertise – Experienced software validation engineers
- Manufacturing Systems Compliance – we provide assistance in validating Building Management Systems(BMS), Computer Integrated Manufacturing (CIM),Manufacturing Execution Systems (MES) Compliance and Laboratory Information Management Systems (LIMS)
- IT infrastructure/ Data Center Qualification
Project Management
We offer expert project management services to ensure your CQV projects are executed smoothly from start to finish. Our approach integrates planning, coordination, and execution to achieve your project goals on time and within budget, while maintaining the highest standards of quality and compliance.
- Comprehensive project plans
- Facilitate effective communication and collaboration
- Monitor and manage project budgets
- Identify, assess, and mitigate potential risks
- Implement tools and methodologies
- Ensure adherence to quality standards and regulatory requirements
10+
Years of Experience
84+
Delighted Clients
161
CQV Projects Completed
27+
Qualified Experts
Partners and Clients
Moderna
Vertex
Novo Nordisk
Abott
Baxter
Medtronic
Partner with Puresynk to Enhance Your Operations
Get In Touch Today
Streamline your Commissioning, Qualification, and Validation processes with our expert consulting and comprehensive solutions. Gain real-time visibility, improve efficiency, and ensure compliance with our tailored services.