CQV (COMMISSIONING, QUALIFICATION, AND VALIDATION)

QACAL is one of the leading CQV (Commissioning, Qualification, and Validation) services provider globally for the entire life science segment includes pharmaceutical, medical device and food industry.

Core Focus-Sterile Facilities

  • Our team consists of experts & SMEs in the validation of facilities, utilities, equipment, computer systems & processes.
  • We guide companies in selection of right Validation strategy and fully support from protocol preparation to execution to data analysis.
  • Our team of CQC experts can support your company in the full CQV lifecycle as well as save your time and money during execution of the project.

C&Q References / Guidelines

  • ISPE Baseline® Guide Volume 5: Commissioning & Qualification
    • Impact Assessment
    • Good engineering practice (GEP)
    • Design reviews
    • Commissioning
    • Qualification (IQ, OQ and PQ)
  • ASTM E2500: Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
    • Risk‐based and science‐based approach.
    • Subject Matter Experts (SMEs) to drive the specification, design, and verification.
    • Risk assessments to determine verification needs
    • Verification list
    • Verification test matrix

C &Q Approach

ASTM 2500 & ISPE BASELINE & GEP (Good Engineering Practice)

Our Expertise

  • Facilities Equipment
  • Utilities Equipment
  • Greenfield CQV Projects​
  • New Production Suite Commissioning​
  • Decommissioning 

Total CQV Lifecycle and Documentation:

  • Project Planning
  •  Validation Master Plans (VMP)
  •  User Requirements Specifications (URS)
  •  Risk Assessments
  •  Protocols
  •  FAT
  •  SAT
  •  Summary Reports
  •  Traceability Matrixes
  •  Calibration Matrix
  •  SOPs
  •  Integrated Commissioning and Qualification (ICQ) ​
  •  Validation Protocol Format​
  •  Design Qualification (DQ)​
  •  Installation Qualification (IQ)​
  •  Operational Qualification (OQ)​
  •  Performance Qualification (PQ) ​
  •  Good Automated Manufacturing Practice (GAMP)​
  •  Current Good Manufacturing Practice (cGMP) Review​
  •  Continued Process Verification (CPV)​
  •  Pre-Operational Verifications