Legacy systems
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This document discusses the validation of legacy systems. It begins by defining a legacy system as one that is currently in use but no longer satisfies regulatory expectations. It then outlines common issues with legacy systems and relevant regulatory standards. The objectives of validating a legacy system are to ensure it properly supports processes and remains compliant. The benefits include assurance that the system is fit for purpose and enhances regulatory compliance. Finally, it presents a typical remediation process flow that includes scoping the system, gap and risk analyses, planning, specification, qualification, reporting, and maintaining the validated state.
Legacy systems
- 1. Legacy Systems Validation Strategy 18th Annual Validation Week Philadelphia, October 2012 Yau Kai Wong AD, QA Compliance & Validation Novartis Pharma Corp.
- 2. Agenda v What is Legacy System v Issues with Legacy System v Regulatory Standards v Objective Benefits of Legacy System Validation v Remediation Process Flow 2
- 3. What is a legacy system? v There is no formally accepted definition of “Legacy System” v GAMP Good Practice Guide (GPG) – a Legacy System should be considered to be an GxP relevant system that is in place and in use, and which is deemed not to satisfy current regulatory expectations. 3
- 4. Issues Encountered with Legacy System v Ownership of system v Validation package v Security v System functionality v Data integrity v Archiving of data 4
- 5. Regulatory Standard v CFR – 21 CFR v ICH – GMP v Industry – ISPE, ASTM v Corporate – Quality Manual, Policies, SOPs, 5
- 6. Objective of Legacy System Validation v To ensure that the legacy system properly supports the process v To ensure that the legacy system has been properly installed, is operated correctly, and that procedures and practices are in place to allow it to be maintained in a state of control throughout its useful life v To provide a framework to demonstrate regulatory compliance 6
- 7. Objective of Legacy System Validation v To establish a complete set of system documentation providing a precise definition of the operating environment, functionality, hardware and software, procedures and reference manuals associated with the legacy system v To provide indexes to the documentation set (i.e. by the use of traceability matrices for documents and user requirements) 7
- 8. Benefits of Legacy System Validation v Assurance that the system is fit for purpose and relevant to the process that it supports, from both a business perspective and a GxP perspective v Understand of the actions required to achieve compliance with evolving regulations, e.g. 21 CFR Part 11 v Enhance confidence in the engineering of the legacy system 8
- 9. Benefits of Legacy System Validation v Demonstration that users are competent to operate the legacy system to an appropriate level and are provided with approval procedures v Provision of a baseline from which to manage change control v Potential to reduce system maintenance costs 9
- 10. Remediation Process Flow 10
- 11. Typical Legacy System Remediation Process v Scope v Gap analysis & risk Assessment v Planning v Specification ² Design ² Configuration Management v Qualification v Reporting v Maintaining the Validated State 11
- 12. Scope Phase v A Master Plan, or equivalent document, formally identifies the Legacy System under review ² Reviewed and updated to ensure that it includes all legacy systems and references all legacy system qualification activities 12
- 13. Gap Analysis & Risk Assessment v Conduct gap analysis against industry standard, ”V-model”, change control history v Determine the difference between what is in place and what is required to demonstrate the system is in control v Perform risk assessment to determine the criticality of the system to the process v Gap analysis and risk assessment together will help determine the qualification strategy and remediation priority 13
- 14. Planning Phase v Established a Plan (e.g. RMP, QMP, etc.) ² responsibilities ² priorities ² what activities will be undertaken to qualify the system 14
- 15. Specification Phase v User requirement - need to understand in detail the business process or production process the legacy system supports v Contains the up-to-date system description covering hardware, software, and the system environment 15
- 16. Qualification Phase v Using the “V-model” as the framework v Installation qualification ² Confirm compliance with the controlling specifications and create new baseline against which to manage ongoing change control v Operational qualification ² Demonstrate that the system works across its expected operating ranges, and challenge the critical areas v Performance qualification ² May or may not needed 16
- 17. Reporting Phase v Review the results and draw a conclusion on the continued use of the system 17
- 18. Operational Phase v Ensure that the operational part of the legacy system’s lifecycle is maintained in its validated state ² Roles and responsibilities ² SOPs up-to-date ² Change control management ² Incident management ² Performance monitoring ² Configuration management ² Periodic review ² Record retention, archiving, and retrieval ² Retirement 18