The Life Cycle of a Computerized System (CS) in the Life Sciences Industry
The life sciences industry is dynamic and rapidly evolving, with pharmaceutical companies needing to keep pace with the latest technological advancements and regulatory updates. To stay competitive and compliant, companies are increasingly relying on Computerized Systems (CS) for critical functions such as manufacturing, quality control, distribution, and regulatory compliance. Ensuring that these CSs are designed to meet all current regulations and operate according to their intended use throughout their life cycle is essential—this process is known as Computerized System Validation (CSV).
According to GAMP® 5 guidelines, the life cycle of a CS consists of four main phases: Concept, Project, Operation, and Retirement. This article explores the specific challenges and potential risks associated with each phase and how Rescop’s services can help address these challenges effectively.
Phase 1: Concept - Initiation Phase
The Concept phase involves defining the system at a high level, creating initial requirements, and outlining the project's scope and intended use. Companies must decide whether to develop the system internally or purchase it from a vendor, allocating the appropriate resources accordingly.
Potential Risks:
- Inadequate Requirement Definition: Poorly defined requirements can lead to scope creep and increased costs.
- Unrealistic Budgeting: Underestimating costs or resources can jeopardize the project.
- Skill Set Deficiencies: A lack of the necessary skills within the organization can hinder project success.
- Vendor Selection Risks: Choosing an immature or unsuitable vendor can result in compliance issues or inadequate support in the future.
Mitigation: Rescop’s experts can identify and mitigate risks from the outset. Our professionals also audit suppliers/vendors to ensure compliance and reliability.
Phase 2: Project - CS Validation
In the Project phase, system requirements are refined, and the CS is installed, configured, and tested, with all necessary documentation prepared. Effective risk management and critical thinking are essential to determine the appropriate level of testing. All stakeholders—including project managers, system and process owners, IT, quality assurance, subject matter experts (SMEs), and validation engineers—must collaborate to validate and release the CS for operation within the project timeline.
Potential Risks:
- Incomplete Testing: Inadequate testing can lead to operational failures.
- Project Delays: Delays in validation can postpone the system's release.
- Documentation Errors: Inaccurate documentation can lead to non-compliance during audits.
Mitigation: Rescop’s CSV experts ensure comprehensive, risk-based testing that meets regulatory standards. We also provide efficient project management and ensure accurate, compliant documentation.
Phase 3: Operation - CS Run & Support
After a successful system release, the Operation phase begins, which is a critical period for the long-term functionality of a CS. This phase is essential, as a CS may operate for years before decommissioning. Companies must plan and allocate resources to maintain validated and compliant systems through effective procedures and best practices.
Potential Risks:
- Loss of Validation State: Poorly managed changes or upgrades can result in losing the system's validated state.
- Change Management Failures: Poorly managed changes can introduce new risks.
- Non-Compliance: Accumulated unresolved deviations can lead to significant compliance issues.
Mitigation: Rescop provides ongoing validation support by developing and supervising operational procedures and assisting with change and deviation management.
Phase 4: Retirement - CS Decommissioning
The Retirement phase involves processes and controls necessary to retire, decommission, or dispose of a system. A thorough risk assessment is required to evaluate the impact on other systems, data integrity, product quality, and patient safety. Proper management of data—backup, retention, migration, and destruction—along with security considerations such as revoking access, are critical. These steps must be detailed in a Retirement Plan and documented in a Retirement Report.
Potential Risks:
- Data Loss: Improper data migration or destruction can lead to loss or corruption.
- Security Vulnerabilities: Failure to revoke access or fully decommission the system can leave it exposed.
- Incomplete Decommissioning: Overlooking dependencies can result in lingering compliance issues.
Mitigation: Rescop’s CSV professionals ensure a thorough and compliant retirement process by overseeing and documenting every step.
Facing Challenges with CSV in the Life Sciences Industry?
If your company is grappling with challenges in implementing a new GxP culture, launching new GxP systems or equipment, expanding operations, or seeking additional support for your Validation and Quality team, Rescop is here to help. We provide comprehensive support throughout the entire CS life cycle to ensure your systems remain compliant and operationally effective.
Sources:
- ISPE. GAMP®5; A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition, 2022.
- ISPE. GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems, 2010.
- U.S. Department of Health and Human Services; FDA; Center for Devices and Radiological Health; Center for Biologics Evaluation and Research. General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002.
- Visconti, Antonio. Computer System Validation (CSV) in the Pharmaceutical Industry: Ensuring Quality and Compliance, 2023.