COMMISSIONING, QUALIFICATION & VALIDATION
The need for Commissioning, Qualification and Validation (CQV) within the Life Sciences industry varies widely – from simple resources to current acceptable strategies, approaches and subject matter expertise. Compli provides the resources and in-depth experience to meet all the CV needs and challenges of our clients. We are qualified in all approaches, including:
- Traditional Validation (IOPQ, computer, process, cleaning, methods)
- Commissioning and Qualification, leveraging FAT and SAT
- Risk-based Validation
With more than twenty (20) years of providing CQV resources and executing CQV projects, Compli brings a wealth of knowledge and understanding to meet your project’s requirements with the flexibility needed to accomplish a project successfully. Our broad range of expertise offers innovate and cost-effective solutions, while building and maintaining positive relationships.
Compli’s thorough understanding in all aspects of CQV, FAT and SAT allows us to recognize process flows and capitalize on leveraging minimum redundancy while creating continuity and establishing reliable and repeatable manufacturing processes.
- Equipment Qualification
Compli’s experts are experienced in all facets of equipment qualification. We utilize a cross-functional team to develop documents that meet your unique requirements.
Our experience includes:
- Equipment Turn-Over Package Development and Review
- Startup and Debugging
- Punch List Development and Management
- Protocol Development, Review, and Execution
- Cycle Development
- Engineering Studies
- Summary Reports
- Traceability Matrices
- Change Control
- Periodic Requalification
We have experience with the qualification of a wide range of process equipment.
- WFI and Purified Water
- Compressed Gasses
- Clean Steam
- Waste Inactivation and Neutralization
- Liquids, Creams, Ointments, and Suspensions
- Oral Solid Dosage
- Packaging Lines
- Environmental Chambers & Controlled Temperature Units
- Process Equipment
- Upstream Processing
- Downstream Processing
- Autoclaves (Dry Goods, Liquids, Decontamination)
- Parts Washers
- Bio Safety Cabinets
- Process Tanks
- Facilities/Utilities Qualification
Compli has the technical expertise in performing facility qualifications including:
- Cleanroom Classification (FDA, EU, ISO)
- Environmental Monitoring (Non-viable and Viable)
- Recovery testing
- Air Flow Velocities and Visualization
- Room Finishes
- TAB Review
- Differential Pressure/Temperature/Relative Humidity
- Security Systems
- Cleanroom Classification (FDA, EU, ISO)
- Process Validation
Compli supports every stage of the Process Validation process. Our team of Process Validation experts are well-versed in the FDA Process Validation Guidance Document and relevant EU guidelines, enabling them to assist in the implementation of Stages 1, 2, and 3.
- Cleaning Validation
Compli has the capacity to provide comprehensive support in the development and qualification of your Clean-In-Place (CIP) or Sterilization-In-Place (SIP) processes, ensuring they meet the necessary standards and requirements.
Our experts perform the following services:
- CIP cycle development and execution
- SIP cycle development and execution
- Cleaning Validation Master Plan
- Cleaning Validation protocol development and execution
- Clean, Dirty and Sterile Hold Time Validation
- Computer Systems Validation
Our Computer System Validation Specialists have in-depth knowledge of regulatory requirements and best practices, ensuring that your systems are not only compliant, but also operate effectively and reliably.
Compliance with 21 CFR Part 11 is vital for ensuring the integrity and reliability of electronic records and signatures. This regulation mandates system validation, secure audit trails, access controls, data integrity safeguards, and identity verification procedures. It is essential for industries under FDA regulation to maintain electronic record integrity. Our team of proficient experts specializes in Computer System Validation (CSV) according to 21 CFR Part 11 and data integrity principles.
We provide comprehensive assistance in creating and implementing Computerized System Validation protocols for various systems including:
- ERP Systems (SAP, CMMS)
- BMS/BAS (Building Management Systems/Building Automation Systems
- PCS/DCS/SCADA (Process Control Systems/Distributed Control Systems/Supervisory Control and Data Acquisition)
- MES (Manufacturing Execution Systems)
- QAS (Quality Assurance Systems)
- LIMS (Laboratory Information Management Systems)
- PLCs (Programmable Logic Controllers)
- Analytical Instrument Qualification/Method
- Validation Program Management
Compli boasts an in-depth understanding of the validation lifecycle, continuously enhancing our proficiency by staying up-to-date with the latest regulations, guidance, and best practices. Establishing, executing, and sustaining a robust validation quality system is imperative for ensuring compliance and streamlining validation initiatives across an organization. The adoption of a risk-based qualification program can result in increased efficiency while upholding stringent compliance standards.
Compli can support in developing or modifying:
- Validation Master Plans
- Validation Project Plans
- Corporate Guidance Documents
- Validation SOPs
- Validation Best Practices
- Risk Assessments and System Classification
Compli also has in-house Project Managers who can assist with project scheduling and budgeting. Our Project Managers are skilled in several project planning resources including Microsoft Project and SmartSheet. We accurately plan, budget, and forecast projects.
Compli can support electronically-based documentation systems and has experience with:
- Veeva Systems
- Validation Support Services
Compli has a wide offering of Validation support services to ensure the smooth and compliant operation of your processes and systems.
These services include:
- SOP Development
- Deviation Management
- Change Control
- Documentation Management
- Batch Record Review
- Vendor Audits
- Facility System and Design Review