By implementing electronic validation, you position yourself for the future and can leverage automation to streamline and standardize validation processes. This reduces manual workload, minimizes risks, and enhances quality.
The concepts of verification, validation, and qualification are familiar to those active in development and production within the Life Science sector. These terms often bring to mind document-oriented quality assurance activities as significant efforts in processes. The concepts themselves span across many disciplines, processes, and systems where accuracy, repeatability, reliability, and compliance with regulations, routines, and processes are key parameters.
Sometimes referred to as the system lifecycle, it essentially spans from the “birth” of the system, when requirements are defined, to its “grave,” or decommissioning, which could range from a short period to decades. Between these points in the system lifecycle, numerous activities occur to maintain its validated state (MVS). Initially, this includes a verification phase when the system is commissioned, involving extensive qualification and validation testing, and the establishment of procedures to ensure ongoing correct handling.
Managing computerized systems often involves a combination of the system itself (software, hardware), the controlled function (procedures, people, equipment), and the context within which the system operates. As part of this framework, several supporting processes need to be in place to complement the verification efforts, such as traceability, deviation handling, document management, and archiving.
What is Electronical Validation?
Lemontree offers solutions to perform these tasks electronically—instead of manual routines with paper-based testing, reporting, and requirements management. By implementing electronic validation, we ensure that the data and systems used in the research, development, and production of pharmaceuticals and medical devices achieve higher reliability and repeatability. Automated traceability and easy coverage visibility ensure nothing is overlooked. The testing level can be easily matched to the level of verification assessed by the risk-based analysis.
Through the correct use of digital tools and electronic validation systems, a higher level of quality is achieved. Lemontree’s solutions in this area are proven in regulatory environments and can be set up to comply from requirements specification to decommissioning, including integrated traceability and deviation management within the solution. Requirements, test cases, test execution, and deviations are stored in the platform, which can also include screenshots, recordings, and test results with full traceability.
Electronic validation systems handle test cases such as IQ, OQ, PQ, both before execution and for reporting results. Traceability to URS requirements is created through Traceability Matrices linking tests, results, and any deviations associated with test cases. Additionally, design, system, and functional specifications can be automatically linked, and Design Qualification (DQ) can be digitally performed within the system. Automatic references make updates and changes in the process straightforward and require no manual reference updates.
What can Electronical Validation Systems solve digitally?
What validation should be performed in electronic systems?
In Life Science, the concept of validation is frequently used for various activities. Processes can be validated, method validation and cleaning validation are other types of validations. Some validations are more suitable than others to be performed electronically.
Using electronic validation does not change what or why validation is conducted; the intended use, risk assessments, and GMP impact remain the same. Instead, the execution is shifted from paper-based to digital systems.
Electronic validation is well-established in Life Science for software development, system implementation of computerized systems that control lab systems, where execution is significantly enhanced by digitalization.
Electronic validation also fits well within the change process for existing systems, as Change Control today often occurs in electronic systems already. This allows direct linkage to validation systems, ensuring easy traceability between Change, testing, deviations, and reporting directly within the systems.
How is electronic validation implemented?
The implementation of electronic validation tools needs to be done systematically, starting with setting up the right platform along with associated processes and assessing the system’s regulatory GxP impact. When properly established, electronic validation can replace paper-based methods, streamline processes through more efficient workflows, and enhance quality and GxP compliance. Materials, tests, and documentation can be reused throughout the lifecycle. Electronic validation also facilitates regulatory audits as all documentation is stored and tracked continuously for easy monitoring. Templates and test cases can be standardized, thereby rationalizing validation processes and workflows.
Furthermore, electronic validation systems are essential for future automation of testing, which is impractical with paper-based methods. When correctly implemented, these systems in the medical technology sector, where validated software is part of the product, can integrate to support development processes efficiently. This integration ensures regulatory compliance and seamless development, avoiding handoffs and retesting as separate processes.
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Frequently Asked Questions aboutElectronic Validation
Here you will find answers to the most common questions we receive from our customers. We have gathered information and solutions on various topics and issues that may arise. Whether it’s technical questions, product information, or general inquiries, we are here to assist you.
