computer systems validation (CSV) and IT

CSV

Our experienced team of 3 dedicated CSV staff assess and maintain the computerised systems we use for clinical trials. Whether a system is used to generate ECGs, or for telemetry on our wards, or to monitor the temperature of fridges and freezers for sample storage, we subject it to strict assessment and comprehensive validation procedures.  Strict change control ensures the highest standards of data security and integrity.

Working to our Master Plan and comprehensive SOPs, we

  • ensure compliance with 21 CFR Part 11 and Annex 11
  • review relevant systems regularly throughout their lifecycle
  • store all documentation, whether electronic or in paper format, to comply with backup/archive and retrieval regulations

Our CSV Manager has over 20 years’ experience at HMR, including 14 years within the IT department. He’s worked across a wide range of teams and functions, gaining valuable knowledge of system functionality and infrastructure. Having completed the GAMP5 training course, and being a current member of the International Society for Pharmaceutical Engineering (ISPE), he’s well placed to advise on validation, and to ensure that we follow best practice.

Excellent project management skills are key to organising and maintaining our inventory of validated systems, and ensure that the company achieves its aim of achieving the very highest standards of patient safety, and product and data quality.

IT

We maintain a highly secure IT network to support clinical trials at HMR, to ensure the highest standards of reliability and conformity. Our infrastructure is heavily encrypted to safeguard the confidentiality and integrity of data.

We follow Information Technology Infrastructure Library (ITIL) best practices for change management, and formally document our work to establish uniform engineering, technical criteria, methods and practices. That enables us to introduce changes efficiently – through planning, testing, communicating, scheduling, documenting, and evaluating – without negatively affecting our service to customers.

Strict change control with rigorously vigilant review ensures that our systems remain 21 CFR Part 11 compliant and validated for use.

We follow the International Society for Pharmaceutical Engineering (ISPE) guidance, and Good Automated Manufacturing Practice (GAMP). To ensure full regulatory compliance, our IT department integrates tightly with the CSV and our Quality Assurance team.

We follow ITIL CSI – Continual Service Improvement. We use PRINCE II project management to deliver upgrades, ensuring continuity of service for our clinical teams, pharmacy, laboratory, and data managers, all the way through to our internet services for volunteers.

Our team has 50+ years of IT industry experience, with 16 of those in Clinical Research Organisations.