COMPUTER SYSTEM VALIDATION (CSV) SERVICES

In the pharmaceutical industry, maintaining data integrity and ensuring compliance with regulatory standards are critical to the success and safety of operations. As the industry becomes more digitized and automated, ensuring that the systems managing critical data are properly validated, secure, and compliant is essential. GAMP 5 (Good Automated Manufacturing Practice, Version 5) provides a framework for validating automated systems and ensuring that data integrity is maintained throughout the product lifecycle. With increasing regulatory scrutiny, GAMP 5, combined with robust data integrity practices, ensures that pharmaceutical companies meet global standards for quality, compliance, and safety.

Our Computer System Validation (CSV) services ensure that your software and systems, including Analytical applications comply with 21 CFR Part 11 and EU Annex 11 requirement. We help validate systems to ensure data integrity, system security and audit trails.

We offer a secure, validated software environment designed to protect and maintain the integrity of your computer system, ensuring patient safety and compliance in healthcare operations.

Computer System Validation is essential requirement for below systems:

  • Computer Systems connected with Laboratory instruments (HPLC, GC, ICPMS, LCMS/MS, GCMS/MS, FTIR, UV-Vis Spectrophotometry, Auto titration instrument etc.,)
  • Laboratory Management system / Stock Management Systems (LIMS, ERP, SAP, etc.,)
  • Process Automation Computer systems (PLC's SCADA, HMI, etc.)
  • Spreadsheets used for Calculation
  • GMP activities related software (QMS, Batch release, Document control, Labelling, etc.,)

GAMP 5 Compliance and Computer System Validation Services:

  • System Qualification: Service providers assist in the qualification of automated systems, including software, hardware, and control systems, ensuring compliance with GAMP 5 guidelines. This includes documenting the entire system lifecycle—design, installation, commissioning, and decommissioning.
  • Risk-Based Validation: Based on the GAMP 5 approach, the validation process is tailored to the risk associated with each system. High-risk systems that impact product quality or patient safety receive more rigorous validation protocols.
  • Data Integrity Audits: Conducting thorough audits of data management practices to assess compliance with data integrity regulations such as 21 CFR Part 11 and EU GMP Annex 11. The audit identifies areas of non-compliance and provides recommendations for improvement.
  • Data Governance Strategy: Developing data governance frameworks that define clear policies, roles, and responsibilities for data management, ensuring that all data is accurate, secure, and consistently maintained throughout its lifecycle.
  • Audit Trail and Electronic Signature Management: Ensuring that electronic records and signatures are properly implemented and maintained in compliance with 21 CFR Part 11 and EU GMP Annex 11 and other relevant regulations. This includes implementing systems that log and track all changes to data and providing mechanisms for secure electronic signatures.
  • Spreadsheet Development and Validation Service: Our Spreadsheet Development and Validation Service ensures that your spreadsheets are not only built to meet your specific needs but also rigorously tested for accuracy and compliance. We specialize in creating customized, user-friendly spreadsheets tailored to your business requirements while ensuring they are validated for data integrity, consistency, and adherence to industry standards. From design to validation, we ensure that your spreadsheets are optimized for performance, reducing errors and enhancing data reliability for better decision-making and regulatory compliance.