Validation management for Life Science projects is an important part of the glue that connects project implementation with quality assurance and ultimately patient safety. Through a conscious risk-based implementation not only ensures compliance with regulations and standards, but also increases the likelihood that deficiencies and potential sources of error are detected in time. The role of the validation manager therefore becomes an indispensable cog for successful, cost-effective projects that ultimately have a profound impact on people's lives and well-being.
The right skills are crucial for results
The role of a validation manager is to ensure that a piece of equipment, system or process complies with the relevant standards, rules and specifications and is fit for intended use. The validation manager leads the validation and qualification work by planning and designing strategies that underpin the design and execution of the verification of, for example, the product or system to demonstrate that it meets the expectations and requirements that have been set. This includes planning, conducting and documenting tests and reporting results and any deviations to the relevant parties, but to even get there a lot of preparatory work is needed in terms of setting the scope, assessing the relevant suppliers and what can possibly be integrated through reuse and risk identification.
The validation leader plays a complex key role in ensuring the quality and conformity of the final product or service based on the current requirements, therefore it is also desirable that this is involved already in the requirements development. In order to lead the validation in a project, it requires that the responsible person has knowledge of both the industry and regulatory requirements and possesses good communication skills. In addition, experience from previous validation projects is essential to anticipate potential risks or pitfalls and proactively keep the project on time and within budget.
Validation is most intensive during the implementation of a project, for example before the manufacture of a new product can start and then be released on the market. Monitoring and quality follow-up then take place throughout the life of the product. A good strategy can therefore be to invest in skills over a certain period, preferably early in the planning. In one investment project where we led the validation, the customer's need was to increase the production rate and add more equipment to their production. For the validation manager, this meant quickly identifying risks and, together with the project manager, planning supplier tests and internal optimizations to minimize production disruptions within given time frames for delivery and installation. So what are the responsibilities of the validation manager and what challenges can a validation manager face in his role during ongoing investment projects?
The challenges of the validation manager
Validation management means taking responsibility for everything from strategic planning to risk management and resource estimation for the different project phases with a focus on validation, but above all making the collaboration for the above work in the project team. A validation leader is responsible for coordinating and managing the other validation resources, which also requires soft skills from the person. Achieving the desired outcome of an investment project within a reasonable timeframe and at a reasonable cost requires clear planning, early management of risks and resource estimation according to the chosen strategy focusing on patient safety, product quality and data integrity and here the validation leader is one of several key players.
Time pressure
At the beginning of an investment project, it is critical to understand the requirements of the equipment, process and other elements to be verified by the validation, which are often complex and time consuming. In projects with tight deadlines, it can be tempting to take shortcuts to save time, but this often leads to delays and deviations in the long run. Validation in investment projects can last up to several years depending on the scope and when the project is already delayed, it is easy to rush into testing. In one example, based on a real-life experience, the equipment was shipped despite the fact that there were deficiencies in the FAT (Factory Acceptance Test) precisely because of the tight timeframe that had to be met. In such cases, the result is a piece of equipment with possible deficiencies that either need to be addressed at Location or will generate nonconformities, which is more time-consuming when entering qualification.
Regulatory requirements
Another challenge that validation managers encounter is suppliers who are not used to working with the regulatory requirements that the Life Science industry imposes on, for example, the purchase of specific equipment. This means that the validation manager needs to be able to be the bridge between customer and supplier to ensure that both the regulatory requirements and the customer's own requirements are met. In order to achieve the goal, to have all equipment and systems on Location by the deadline and that they meet the requirements, it is incredibly important to have good cooperation and to have a solution-oriented attitude.
Holding loose threads together for secure propulsion
Given the challenges that can arise during an investment project, it is of great importance that the validation lead is the spider in the web and can drive the qualitative task throughout the project. Successful requirements gathering and technical testing can be key to keeping the project on time and on budget while delivering a functioning system or process that works as intended within the business. As a validation leader, it is also crucial to consider what solutions need to be applied for the validation. Being able to adjust the scope based on the risk and complexity of the elements involved, establishing effective partnerships with the supplier and actively participating early in the project are solutions that all contribute to a successful project. It also increases the likelihood of actually finding any deficiencies before the product reaches the end user, the patient - and that, of course, can make all the difference.
A validation leader who understands the client's business can also support in-house training if colleagues are working on the same project. It is also not uncommon for a validation leader at larger clients to be involved in several parallel projects. In summary, the validation leader can create a calm in a business as they can relieve existing resources and know which corners can be rounded to optimize time in the best way based on experience.
Successful projects are those that deliver good results
In some investment projects, customers have been helped to bring new products to market quickly and qualitatively by implementing the changes and improvements required by governing regulations. Roll-outs of new system solutions for more quality-assured production to fully manufacturing production lines are some examples of good results, thanks in part to effective validation management. Doing the right things right from the start provides favorable conditions for a project, thus reducing the number of deviations/changes that tend to appear along the way.
With a flexible and proactive approach, within the timeframe, the validation manager can contribute to a cost and resource efficient project - without compromising compliance.
Do you want to know more about how we work with validation and quality assurance? Click on the link below or contact Karin Tördahl, Consultant Manager with us.
Quality & compliance | Plantvision
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