Equipment Validation and qualification is a time consuming process that has the potential to delay the release of products to the market. Some aspects, and documentation practices related to the equipment validation and qualification process, are critical and provide a high degree of assurance that a quality product is produced.
Many of the non value-added validation and qualification practices are rooted in a lack of understanding of GMP requirements. Rather than run the risk of non-compliance, companies have designed onerous procedures to remain complaint. The problem is that some of these procedures are not required and lengthen the amount of time to validate and qualify equipment; delaying the time to market.
Through ValGenesis, companies can design procedures that comply with regulatory requirements, and the system will control the process. By standardizing the methodology for validation and qualification, our clients can be assured that the appropriate level of validation and qualification is completed, no more or no less.
Equipment validation involves documenting all processes in the validation lifecycle process., After the initial validation process, the validation status of the equipment should be continuously maintained throughout the lifecycle for the validated system. Most equipment validation projects involve the following phases,
- Validation Plan and Projects
- Specifying design, user and functional 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)
- 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 equipment systems. Life Science companies can replace tedious paper or manual systems with an electronic, automated validation lifecycle management system, to support the risk based approach and make the equipment validation process 100% electronic.
ValGenesis provides the following seven integrated functional modules to manage the entire equipment validation process electronic.
To create, review and approve validation plans, projects and project summaries.
To create, review, approve and manage requirements and traceability matrices.
To create, review, approve and manage risk assessment, following Failure Modes Effects Analysis (FMEA).
To author, review and approve validation documents.
To perform electronic (paperless) or Manual execution. Review and approve the executed protocols. Manage failures with controlled workflow.
To create, review and approve periodic review schedules.
To manage the change control process.
Enforcing Standard Methodology through Frameworks
When it comes to equipment validation, the amount of documentation required is interpretive and differs from company to company, department to department, and user to user. Variation causes inefficiency and hampers productivity. With ValGenesis, the system provides the facility to build standards that apply to the organization as a whole.
One of the key mechanisms in ValGenesis, that can be used to enforce standardization, is validation frameworks. The concept of validation frameworks is unique to ValGenesis and essentially allows a user to determine the minimum level of documentation that is required in order for any equipment to be considered as validated. Validation frameworks are built to apply to a group of equipment; whereby any equipment that belongs to the group is tagged as validated, once the required document deliverables have been completed. Essentially, the validation framework tells us what we need to do in order to validate, or qualify any equipment.
Enforcing Document Consistency through Templates
Through the template management functionality, consistency in the content generated for equipment qualification documents can be enforced. The template functionality within ValGenesis allows end users to register any number of MS Word documents to be utilized as templates. The system is equipped with the ability to lock sections of any document by page, or by table. When a section is locked, the author will not be able to make any changes to that portion of the document. For example, the preamble to any Operational Qualification document can be locked, so that it cannot be modified by authors when it has been assigned for authoring.
Templates can be almost completed; whereby when the template is assigned to a user for development, the author is required to make only a few changes, or they can be a bare skeleton; whereby the author is required to draft most of the content required for the document.
Managing Equipment Inventory with Real Time Validation Status
ValGenesis has been designed to manage equipment inventory easily. Any equipment that is registered in the system will be associated through the user defined classification structure. This logical association enables our clients to track specific equipment quickly and determine the validation status. ValGenesis provides real-time validation status, for equipment and systems, with complete audit trail for any associated document. Along with providing validation status, users can also locate specific documents for any equipment and view where a document came from, where it is now, and where it is going to next, in real time.
Leverages MS Word and Excel for Validation Protocols
Authoring any documents in ValGenesis is a simple process as document authoring is accomplished using 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 related to validation. The application does not enforce rules that are outside of current validation methodology. Instead, ValGenesis effectively moves away from paper based to electronic validation, without disrupting how equipment and instrument validation is conducted.
Real Time Metrics and Tracking
Throughout the validation lifecycle, ValGenesis provides real time metrics. Through the numerous reporting tools built into the system and the Ad Hoc Report Generator, information related to validation can be easily attained. Reports can be generated, in order to find out how effective a department, group, or user is, along with how many validations have been completed, or are in process, for a group of systems. Through real time metrics, users are able to take snap shots of the validation process, to gauge overall validation efficiency.
The ValGenesis Dashboard provides a single point-of-access to all validation projects and allows the tracking of the validation status for any system, or associated documentation, in real time. 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.