Computer System Validation
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 particular, 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:
- Guarantee the implementation and development of computer systems using best practices with a minimal number of defects and in line with customer requests.
- Produce the necessary documentation to ensure system compliance in accordance with international pharmaceutical standards (particularly 21 CFR part 11 and Annex 11).
We support our 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.
For the Computer System Validation needs of our customers, we offer two levels of services: Strategic Support Model and Consultancy Model.
seQure is the business unit of Arithmos, related to Quality Compliance and Consulting Services.
Strategic Support Model
With Strategic Support Model, we provide a team of experts with the appropriate competence for the activities needed:
- Provide a Project Validation Manager for an EDC system implementation project
- Define a strategy for the validation of a cloud-based system
- Perform a Risk Assessment based on 21 CFR Part 11/GxP
- Support in preparing for regulatory audits (FDA, AIFA, etc)
- Initial training on IT standards
- Develop a quality system for IT activities: policies, processes, procedures and work instructions
- Provide a Help Desk to manage daily communication
We validate regulated systems in an efficient and fully compliant manner for both the GMP, GVP, GLP and GCP environment. We are made up of a team of expert consultants who can provide consultative support for maintenance, revision and verification activities regarding the validation status of applications.
To optimize the validation process, we apply an approach based on pragmatic risk and efficacy assessment in order to focus on the more critical areas of validation.
Our consultancy approach is related to the maintenance of computer systems with the goal of supporting companies in guaranteeing that systems are maintained in accordance with regulatory requirements, secure and adequate for the needs of end-users. This is done through a documented process that ensures a system continuously functions as intended.
- Periodic Compliance Review of computerized systems and IT infrastructure
- Management, review and approval of change requests (Change Control)
- Internal Audits
- Continuous training for end-users
- Remote technical support for issues related to computer system management