Computer System Validation

Life Sciences firms need robust and regulatory compliant computer systems & software to maintain consistency, reliability and accuracy of operational data. The existing software validation approaches used to minimize code defects, typically rely on paper-based or manual systems, and are time-consuming and inefficient.

LTI’s Computer Systems Validation solution provides automated testing services for various software systems used in the Life Sciences industry. Our solution, which follows industry best practices, as well as FDA mandates, helps prevent code defects from reaching production environments.

Highlights

  • Well-defined framework for end-to-end implementation of CSV.
  • Covers all aspects of CSV such as Risk Assessment, Governance Model and Ongoing Support.
  • Compliant with GxP & 21 CFR Part 11 standards, and are implemented by certified professionals.

Benefits

  • Increase time-to-market of applications by reducing software defects and increase the overall business agility and productivity, with strong computer systems and software.
  • Reduce the effort & costs involved in manual software validation processes & documentation, by leveraging automation.
  • Ensure 100% adherence to FDA norms.