Strategic Model

AAEAAQAAAAAAAAWEAAAAJDVlNzMzMDc4LTEzZjktNGRjYS1hYzlkLTY1MWM3OGQwNTI5NQPM Clinical can support customers in planning, conducting, reviewing and maintaining the validation status of their applications through GxP assessment, validation planning, user requirement analysis and authoring as well as IQ/OQ/PQ authoring and execution including validation reports.

Computer system validation (CSV) is a documented process for assuring that a computer system does what it is designed to do. Not performing certain computer system validations in accordance with Best Practices could be against the law. Both the EMA and FDA have rules and regulations in effect for GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), GVP (Good Pharmacovigilance Practices) and GCP (Good Clinical Practices).

CSV can prevent software problems before reaching the usage environment. In particularly in the clinical trial field, malfunctioning computer systems can cause serious adverse consequences for the patient. This could in turn lead to lawsuits, fines or eventual shutdown.

A structured and pragmatic approach to Computer System Validation allows end users to achieve two important objectives:

1. Guarantee the implementation and development of computer systems using best practices with a minimal number of defects and in line with customer requests;

2. Produce the necessary documentation to ensure system compliance in accordance with international pharmaceutical standards (particularly 21 CFR part 11 and Annex 11).

The PM Clinical STRATEGIC SUPPORT MODEL provides a team of experts with the appropriate expertise for the activities needed:

  • Provide a Project Validation Manager
  • Define a strategy for validation
  • Risk Assessment Evaluation associated with 21 CFR Part 11/GxP
  • Support in preparing for regulatory audits (FDA, AIFA, etc)
  • Initial training on IT standards
  • Development of a quality system for IT activities: policies, processes, procedures and work instructions
  • HelpDesk to manage daily communication