Tailor-made validation solution
Life Sciences companies, especially pharmaceutical, biotech, and medical device companies, are highly regulated and need to prove that their products and their manufacturing and development processes are consistent. This is the role of validation.
Without validation, the biopharmaceutical and medical device industries cannot register or produce their products.
While the market is increasingly competitive, and new technologies are being used, shortening the lifecycle is very important. However, accelerating this phase without attention to regulatory and data integrity can be very risky.
In the traditional way (based on paper or manual electronic format), it is common to take up to 8 months to complete a validation study.
By streamlining this formal process while maintaining compliance, resources focus on higher-valued tasks: R&D gains more time to innovate, engineering to develop new processes, and the entire team will have engaged quality, since data is easily accessible, and the requirements are clear and ready-made.
The strategy of assigning weights
Any acquisition of GxP systems in the Life Sciences industry usually starts with the definition of user requirements.
These requirements can be of various types such as operational, functional, data, technical, interface, environmental, performance, availability, security, maintenance, and regulatory, among others.
The requirements should be prioritized with an emphasis on identifying mandatory requirements: mandatory (high), beneficial (medium), or nice to have (low).
The formal evaluation of each supplier should be based on their compliance with the established described requirements. It may be that not all suppliers meet 100% of the established requirements, and it will be up to the team to assess the level of risk in each scenario.
The strategy of assigning weights to the fulfillment of requirements versus investment value can be an interesting approach. For example, for quality criteria (mandatory functional and safety requirements) - 50%, medium and high requirements - 10%, for price criteria 40%.
The criteria will vary from company to company, and in case of a tie, technically evaluate which one will best meet the request.
Unlocking Success:
In many cases, global companies have well-established procedures and validated models in place, making it challenging to change the structure.
However, small and medium-sized companies often do not have the resources to make big changes and should adhere to the same requirements as larger companies.
In this blog, we will discuss the advantages and disadvantages of adhering to a strict validation document layout. We will explore how to achieve a faster return on investment and whether a tailored layout is the best approach.
GAMP5®, for example, focuses more on content and risk-based strategy than on layout definition because it recognizes the importance of ensuring the safety and effectiveness of processes in the life sciences industry. By prioritizing content and risk management, GAMP5® enables a more proactive and efficient approach to ensuring product quality and compliance, resulting in tangible benefits for companies and patients. Therefore, while it is crucial to meet requirements, the format in which they are presented may not always be so important.
By critically analyzing these factors, we can identify other options to consider and evaluate the true risks involved. It is important to remain open-minded and willing to explore different approaches to ensure successful implementation.
GO!FIVE® is the only validation and qualification solution with content in the database.
Distinguished in the market with an exclusive Risk, Requirements, and Test Library at your disposal. Utilize our templates or craft and modify your content through the Public Library and Private Library features.
Validation and qualification are increasingly present subjects in the routine of IT, QA, and automation professionals.
Despite this topic not being a recent requirement, there continues to be a knowledge gap and a shortage of resources to assist professionals in attaining compliance and optimizing GxP processes, which can significantly impact adherence to good practices. Although each company has its specificity, there are several standard processes within a type of system, for example, the purchasing process within an ERP, which is common to several companies.
In GO!FIVE® it is possible to select various libraries, according to the process or system that is to be validated, and these libraries contain market best practices, regulatory requirements, and more. It is also possible for the customer to manage their own content through the process of creating private libraries (creating and/or translating pre-prepared validations in their database), as well as saving them for similar validation/qualification projects.
Prioritization of investments
Small and medium-sized companies often encounter the following two scenarios when evaluating costs and setting priorities.
While it may not be possible to directly compare these points, it is important to consider the advantages and disadvantages of focusing on either the layout or content of validation documents.
In this evaluation exercise, we will highlight specific requirements to suggest potential reflection scenarios.
1. Emphasizing Layout Requirements
• It can ensure that the employees will be familiar with the new approach.
• It can ensure standardization according to internal/global templates.
Disadvantages:
• Focusing too much on layout may lead to overlooking. Time for customization and cost are the dark side, for small/medium companies or companies that don't have a big budget but think that the agile/digital approach is the best for them. What really matters?
• The cost of using validation tools with customized deliverable layouts, like those used in the traditional model (manual or manual electronic), impacts costs. It usually takes thousands of dollars/euros to adapt the tool, without being able to take advantage of using the tool from day 1. Normally it takes months to get ready.
2. Emphasizing Robust Content
• Prioritizing content over layout ensures that the deliverables contain comprehensive and accurate information, improving the overall reliability of the document. Do not start a project from scratch.
• A focus on robust content can enhance the depth and clarity of instructions, minimizing the potential for errors or misunderstandings during validation projects. Dozens of contents are already available, and it is easy to establish your own models. For example, create robust validation templates for laboratory systems, and every time you should validate similar systems, download pre-ready and customized content. Specific to your use case and business specifics.
Disadvantages:
• Neglecting layout considerations can make procedures challenging to navigate and understand, particularly for employees with varying levels of knowledge or experience.
In conclusion, both layout and content are essential to crafting an effective validation process. Achieving the right balance between them is vital for producing validation documents that are user-friendly, precise, and easy to understand.
The GO!FIVE® is a software that performs this balancing. It is the only validation management software with content in the database (validation libraries with requirements, risks, and tests for AI and traditional technologies, following guidelines from ANVISA, FDA, EMA, and WHO), there is the possibility of customizing as additional services.
The key decision factors for choosing an off-the-shelf solution or carrying out configurations/customizations are implementation time and cost.
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GAMP5® is a guide that has its intellectual rights reserved by ISPE®. Available for purchase at https://ispe.org/.
