Ensuring compliance with regulations and maintaining the accuracy of computerized systems in industries like pharmaceuticals and medical devices is vital.

Computer System Validation Services

Ensuring the compliance and accuracy of your computerized systems is critical, especially in industries like pharmaceuticals and medical devices. At Qvalitek, our computer system validation (CSV) services are designed to help you meet regulatory requirements and maintain optimal system performance.

Our Services Include:

  • Documentation: We meticulously document system requirements and validation protocols.
  • Testing: Conducting rigorous tests to ensure compliance with regulatory standards.
  • Monitoring and Maintenance: Providing ongoing support to ensure continuous compliance and system reliability.

Regulatory Compliance: Our CSV services adhere to key regulatory frameworks, including:

  • GAMP® 5
  • FDA 21 CFR Part 11
  • EU GMP Annex 11
  • ICH Q7
  • ISO 13485

These standards guide the design, testing, and maintenance of computerized systems, ensuring they are suitable for their intended use and that data integrity, security, and reliability are upheld.

Why Partner with Qvalitek? Partnering with us ensures your systems are compliant and perform optimally, tailored to meet your unique needs while adhering to stringent regulatory standards.

Contact Us: Reach out to Qvalitek to learn how our computer system validation services can benefit your organization. Our expert team is ready to assist you in achieving compliance and excellence in system performance.