A Global Leader in Industrial Automation Solutions

Validation C&Q/CSV

img validations2At PACIV, we ensure with documented evidence, that your automation systems are delivered and implemented meeting their functional intent and that your requirements and the approved design are aligned as to deliver you a sustainable and reliable automation solution.  Our Commissioning and Qualification (C&Q) and Computer System Validation (CSV) services ensure that the development and implementation process runs smoothly, systems are properly handover and that they can be maintained in a validated state through their useful life up to retirement.

Our full C&Q/CSV Life Cycle services include consultancy, planning, development and execution tailored to meet your corporate policies, procedures and validation methods while applying ISPE GAMP™ and C&Q Guidelines.  In addition, we provide all needed supporting services during the Operation and Maintenance phase of the validated systems such as development and execution of CSV SOP’s for System Administration, Configuration Management, Back-up, Disaster/Recovery, Security, Periodic Review and System Retirement.

With over 18 years of planning and execution of C&Q and CSV initiatives for the largest manufacturing facilities of the world’s leading pharmaceutical and biotechnology companies, PACIV resources combine their automation hands-on experience with the knowledge of FDA regulations and industry guidelines (ICH Q9, ASTM E2500, and ISPE (GAMP and C&Q)) to provide you with the adequate risk, right-sized qualification and validation solutions for your systems.  We can advise, design and execute an efficient C&Q/CSV approach following the Risk-Based Management Process, that meets all of the regulatory requirements, while attending to the systems complexity.  Moreover, we can leverage significantly documented commissioning efforts in order to minimize the time and cost of the validation activities.  Our knowledgeable team of engineers can assume primary responsibility for system validation or can provide support to in-house teams. 

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PACIV resources are speakers at international ISPE and ISA events and have contributed to the development of ISPE guidelines.  Our consultant engineers have participated in numerous FDA inspections of our clients’ systems, assisting and responding to any observations from regulatory agencies.

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Our C&Q and CSV Services include:

  • Risk-based Management Process following FDA, ICH Q9, ASTM 2500, and ISPE (GAMP and C&Q) guidelines
  • Gap Assessments
  • Consultancy for FDA 483’s and/or Warning Letters handling (responses and remediation initiatives)
  • Full CSV/C&Q Life Cycle full Services
  • Commissioning & Qualification (C&Q ) Planning, Development and Execution
  • CSV Planning, Requirements, Functional and Design Specification, Traceability Matrix, Final Reports
  • Vendor Evaluations and Qualifications
  • Development and Execution of Testing Protocols (FAT, SAT, IQ, OQ, PQ)
  • Traceability Matrix, Master Document Lists, Reporting
  • Validation Maintenance SOP’s (System Admin., Configuration Management, Security Administration, Backup/Restore, Disaster/Recovery, Business Continuity Plan, Periodic Review, System Retirement)

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