Computer Systems Validation
Computer System Validation (CSV) has been an essential part of FDA-regulated industries for over 20 years, yet as the field has evolved, little has changed around the business process of CSV. For the most part, CSV still requires a high degree of manual effort for tracking and reporting, and the execution of most validation protocols takes place on paper. By and large, predominantly paper and manual based validation processes stifle innovation, cause compliance risk and compromise a life science firm’s ability to bring products to the market on time. Plus, with the increased use of computers along with the progression of evolving software technology, a more advanced validation solution has become essential to the life sciences industry.
Computerized system validation (CSV) involves documenting all processes in the validation lifecycle process, after the initial validation process, the validation status should be continuously maintained throughout the lifecycle for the validated computer system. Most CSV projects involve the following phases:
- Validation Plan and Projects.
- Specifying Requirements (Author, review and approve).
- Risk Assessment (Author, review and approve).
- Authoring design and test case protocols (DQ, IQ, OQ, PQ etc.) (Author, review and approve).
- Creation of Traceability matrices (Create, review and approve).
- Execution test cases and Summary report (Execute, review and approve).
- Management of Execution Deviations (Initiate, assess, review and approve)
- Change control and management.
- Periodic Review.
The current validation approach, which relies on paper and manual systems, is time consuming and inefficient, as documents are needlessly recreated and tedious manual tasks are performed on a routine basis.ValGenesis is a web-based system designed to efficiently manage the complete validation lifecycle for computerized systems. Life Science companies can replace tedious paper or manual systems with an electronic, automated validation lifecycle management system that supports the risk-based approach and makes the CSV process 100% electronic.
ValGenesis provides the following seven integrated functional modules to manage the entire CSV process electronically.
To create, review and approve validation plans, projects and project summaries.
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To create, review, approve and manage requirements and traceability matrices.
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To create, review, approve and manage risk assessment, following Failure Modes effects Analysis (FMEA).
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To author, review and approve validation documents.
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To perform electronic (paperless), Automated, or Manual execution. Review and approve the executed protocols. Manage failures through controlled workflow.
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To create, review and approve periodic review schedules.
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To manage the change control process.
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These are some of the functions provided by ValGenesis to manage CSV:
Managing Computer Systems Inventory
Computer systems registered in ValGenesis are logically organized under categories and sub categories to simplify management of many systems. The audit trail for documents generated will be organized under each system, for easy search and easily manage computer system inventory. Validation status can be determined quickly and easily and documents accessed as to where it came from, where it is now, and where it is going to next, in real time.
Requirement Management and Risk Assessment
Within ValGenesis, requirement documents, such as functional requirements specifications (FRS) or user requirements specifications (URS) are treated as living documents. Requirements can be modified as required by any business process changes. New requirements can be added when warranted, existing requirements can be also be updated, with version control, and obsolete requirements can be removed. Changes to any requirement document can be routed through a user defined approval workflow and once accepted, the system will automatically update the traceability matrices that have been impacted; for forward and backward traceability. Based on the impact, users can build additional testing for a new requirement and link the modified requirements to different test cases, or remove any extraneous test cases that are no longer applicable, due to an obsolete requirement.
As well as managing requirements, ValGenesis provides users with the ability to conduct risk assessment for each of the requirements. The risk assessment process within ValGenesis follows failure mode effects analysis (FMEA) principles, where each requirement is assessed with risk factors. The system automatically calculates the Risk Class and Risk Priority Number (RPN) for each requirement, based on the values assigned to Severity, Likelihood of Occurrence and Detectability.
Leverages MS Word and Excel during the Authoring Process
Authoring any document in ValGenesis is a simple process due to the use of MS Word and Excel. By leveraging MS Word and Excel, users can effectively utilize ValGenesis in a very short period of time. ValGenesis does not require any proprietary online word processors, which would result in a steep learning curve.
ValGenesis was built to complement well established business processes, with best practices related to validation. ValGenesis effectively moves away from a paper based approach to electronic based validation, without disrupting how validation is conducted.
Dynamic Traceability Matrices
Linking requirements to test cases is an arduous task but one that is necessary, particularly in computer validation. The ability to trace forward and verify that requirements have been tested, and to trace backward and verify that tests are actually testing requirements, is time consuming and difficult to maintain in a paper environment. ValGenesis is equipped with a dynamic traceability matrix function that will automatically link requirements to test cases. The dynamically created traceability matrices can be updated manually, as required. If there are any changes to requirements, the system will indicate which traceability matrices have been impacted. Through the ability to view impacted traceability matrices, users are equipped with a tool that enables them to modify existing, add new, or remove obsolete test cases.
Real Time Validation Status and Metrics
Throughout the validation lifecycle of CSV, ValGenesis provides real time validation metrics at any point. The ValGenesis Dashboard provides a single point-of-access to all validation projects and tracks the validation status of any system, or associated documents. It provides 360-degree visibility and control over these activities by automatically capturing and displaying real-time data from validation phases, while work is in progress. With the ValGenesis Dashboard, project teams always know the current status of their efforts. Managers gain real-time insight into the progress, or lack of progress, across their responsibilities. Executives can view all initiatives from a quality and validation value perspective at a high level, ensuring that these fit into the overall strategic direction of the company. In addition, ad-hoc reports can be easily generated, in order to find out how effective a department, group, or user is, along with how many validation tasks have been completed, or are in process, for a group of systems.
Electronic, Automated and manual Execution Options
ValGenesis provides users with the ability to execute documents through an electronic, automated or manual execution process.
Electronic execution feature in ValGenesis was designed to eliminate many of the issues currently surrounding manual execution methods. Some of these issues include, physically storing executed documents, losing or misplacing executed documents, scanning documents to an electronic format, once the execution has completed, illegible handwriting and data entry errors on executed documents. Execution can be quantified by attaching screen shots and supporting documents, at the test row level and/or at the document level.
With automated execution, the system generates test cases dynamically and executes documents in an automated way. Screenshots are captured at the test case row level. Through the automated execution process, users are able to accelerate the validation process of COTS systems and reduce the validation cycle time by 80-90%.
For those firms that prefer to execute protocols following the traditional manual process, ValGenesis has a manual execution option available. Once an execution task has been assigned to a validation engineer, the validation engineer can print the test cases to execute the protocol. Once the protocol has been manually executed, the protocol can be scanned and uploaded into ValGenesis and routed through an electronic approval workflow.
Deviations captured during the electronic and automated validation process will be handled in ValGenesis through controlled workflow.
- ValGenesis provides real time, corporate wide validation status in the dashboard.
- Providing a holistic view of a company’s validation status and easily identifying bottlenecks.
- In the CSV process through templates.
- Always ready for internal and regulatory audits.
- Reduce the cost of Validation process by 40-50% through electronic execution and 80-90% by automated execution.
- Enables a 100% paperless validation process.
- Electronic Validation process meeting FDA 21 CFR Part 11 compliance requirements.
- Enables lifecycle approach in the corporate Validation process with integrated modules.
- Globalizes the Validation process and leverages the resources across the sites.
- Clients can standardize validation activities across multiple sites by defining standard document templates and workflows, and ensuring that mandatory information is captured in the desired format.
- ValGenesis allows users to work in familiar MS Word and Excel, to author, review and approve requirements and test protocols in a controlled and compliant manner.
- ValGenesis significantly improves validation efficiency by automating recurring tasks, improving visibility of the process, generating up-to-date traceability matrices and displaying the impact of any change with associated Risk levels.
- Integrated within ValGenesis; the change control and validation process management modules ensure that all changes are implemented using a pre-defined process. Also, that user can track the validation status of any system and promptly retrieve the related documents to justify the current status, whenever audited ,or inspected.