Paperless Validation

Digital and paperless validation

The “green” approach of CSV Life Science

In their efforts to reduce emissions, consumption and environmental impact, companies in the pharmaceutical industry are trying to transform their business models by prioritizing sustainability. CSV Life Science Group is also mobilizing to become increasingly eco-friendly through a shift to a digital and paperless validation.

CSV Life Science has signed an agreement with Kneat, becoming its first strategic partner in Italy. With Kneat GT the company will implement its services with the digitalization of validation.

Founded in 1998, CSV Life Science, has built over the years a group of companies and professionals capable of providing integrated solutions to the pharmaceutical market. Thus was born CSV Life Science Group, whose intent is to bring together the many divisions and foster their synergy.

The Commissioning, Qualification and Validation (CQV) department has been in operation since the company’s foundation in the early 2000s. After nearly 25 years of activities, it has become a strong and solid division and a point of reference for anyone needing CQV services both nationally and abroad.

Its team of experts is able to offer solutions in response to particularly time-critical needs, in full compliance with GMPs and data integrity requirements. Such is the case with the digitization of validation processes, a service that is becoming increasingly popular around the world and has also landed on the Italian market.

Digital validation for a customer-oriented approach

The Group’s philosophy of placing customers and their needs at the centre has led the CQV area to be interested in the “paperless” validation approach. In an increasingly sustainability-oriented world, no company escape from taking “greener” actions to reduce its environmental impact. In the sensitive pharmaceutical sector, however, standards have to meet very high parameters, and a more eco-friendly approach cannot undermine in any way compliance with regulations.

CSV Life Science therefore thought to move ahead by proposing an alternative approach to its clients. The strategic choice focused on implementing its services with the digitization of validation, through Kneat Solutions, the main digital validation platform.

Therefore, recently CSV Life Science signed an agreement with Kneat, becoming its first strategic partner in Italy.

Through this new partnership, the Group will use Kneat’s state-of-the-art digital validation solution to provide more comprehensive services to its customers, improving operational efficiency and compliance with regulatory standards.

Choosing to implement this step, as Pietro Dottori, CQV manager of CSV Life Science, says, is due to the fact that: “[our company] is committed to innovation and supporting pharmaceutical manufacturers with new challenges. We believe that transitioning to paperless validation is the next step for the CQV process, eliminating data entry errors, increasing data traceability to 100%, and accelerating document revision and approval.

Moreover, embracing a paperless approach to validation aligns with our commitment to environmental health.
We’ve found the perfect partner in Kneat, with their suite of features and talented team”.

Who is Kneat?
A player that approaches all-around digital validation.

Kneat is a SaaS platform for Life Cycle Management validation that digitizes validation from cradle to grave (we could say A to Z), offering life science companies the ability to create, manage, access and extract validation data. Kneat captures all data directly into a secure database, with all entries and changes recorded in a complete and comprehensive time-stamped audit trail. Powerful standard reporting provides instant visibility and insights into validation status, and an interactive dashboard is also available for data presentation and business analysis.

We asked Pablo Fernando Muñoz Pierattini, CSV Life Science’s Computer System Validation manager, a few questions to understand better this new service offered by the Group and learn more about their new partner.

Can you tell us what digital validation

is and the impact it can have on the Italian pharmaceutical market?

Indeed. Digital validation, also called paperless validation, is a new approach that has been in place for several years and has been introduced by international big pharma, which has recently landed in the Italian pharmaceutical market as well, where it is having a lot of success.

This approach compared to traditional validation has several advantages, as it offers us real-time data availability and traceability of all the various activities performed during validation, not only of computerized systems, but also of plant and machinery in the pharmaceutical context.

Dashboard of validation systems

Analysis of templates

So, can paperless validation help CSV Life Science become an increasingly eco-friendly company?

Yes, certainly. Digital validation will enable us to achieve a more sustainable approach. In fact, for some years now, the pharmaceutical industry, through industry 4.0, has been working to reduce paper production by optimizing pharmaceutical processes.

This digital validation will not only help us from the point of view of paper reduction, but more importantly, it will decrease the travel of our technicians in the field. Of course, this will result in a significant reduction in emissions from the less travel that will be required.

In the Italian regulatory environment, has any action and real effort already been taken to mitigate the risks associated with climate change?

Thank you for the question. In truth, Good Manufacturing Practices to date do not include a commitment to climate change. However, ISO standards, including ISO 9001 and ISO 27001, related to information security, have been updated precisely to intercept what are the approaches to mitigate the risks associated with climate change.

At CSV Life Science, being an ISO 9000-certified company, we aim to reduce our impact on climate change partly by starting with such expedients as, as mentioned above, reducing paper and travel.

We can see how many benefits come from digital validation activities.
So what is the best approach and strategy to implement such validation?

The best approach is definitely to establish a standard documentation package. Pharmaceutical companies today are very well structured and already have a solid foundation for the document approach, which is definitely a good starting point that will then need to be implemented within the system.

The first step is to intercept the templates, that is, the entire document package that the company has already developed. After that they are uploaded within the system, and then the design phase is started and the computer system of the equipment or machinery is tested. It must always be ensured that the same flow required by GMP occurs correctly, meeting what are the regulatory expectations of an inspector.

Analysis of workplaces

CSV Life Science was the first Italian company to enter into this partnership with Kneat, which is the leading platform for implementing paperless validation.
Why did you decide to choose this particular company as a partner?

The choice of Kneat as a partner was mainly due to the fact that we saw in them a robust product that has already been on the market for several years and has been used by pharmaceutical companies for quite some time.

Assessing what are the aspects related to the use of this platform on pharmaceutical and related contexts, we decided to undertake this partnership with Kneat. A partner that ensures us a cloud-based solution, which is important to ensure all aspects related to information security and data integrity as required by GMP.

Starting from a solid base that allows us to interface with the pharmaceutical world, strengthened by Kneat’s expertise, seemed to us the optimal solution.

Clients have already seen a benefit: validation work hours have decreased in some cases by as much as 50%.
Can you tell us about a particularly significant practical example or case study?

Today as CSV Life Science Group we have several activities that we are already performing with this system, not only on Computer System Validation but also on machinery and utilities.

Mainly on Computer System Validation we have studied different approaches and we realized that, among the solutions proposed by Kneat, some allow us to reduce the validation effort by up to 50 percent.

The case study that definitely had the most impact on validation effort concerns management. Paperless validation allows us to reduce the time it takes to compile and run the actual tests. On the validation, for example, of an SAP 4HANA we saw at least a 50 percent reduction in testing activities and an 80% reduction in the actual compilation. This resulted in an overall 35% reduction on the total validation effort for the management system.

Clearly on much more complex systems, such as might be an ERP, LIMS or DCS, the validation effort certainly has a significant weight both in project costs and in the management of the resources themselves.

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