In this new success case, we met with Cecilia Santín , founding partner of Felsan S.A. , a company dedicated to the import, manufacture and fractionation of laboratory and haemotherapy supplies.
The company markets diagnostic reagents for in vitro use identified under the name REDIAR. These reagents are manufactured in its plant located in the Autonomous City of Buenos Aires, authorised by the National Administration of Medicines, Food and Medical Technology (ANMAT).
Cecilia, a qualified food technologist, has always worked in the area of quality management. In 2017, the challenge of depapelisation began. The company was looking for a system that would allow them to meet the objective of facilitating the management, communication and collaboration of all the areas that interact with each other.
In 2018 we started looking for a digital system. While looking at the options available, we found Loyal. We were looking for a system that had clients in the pharmaceutical industry, with the idea that at some point ANMAT was going to ask for the digitisation of processes, which at that time was not even being talked about yet.
Felsan decided to implement the Document Management System and Quality Management System modules. The DMS module allows them to manage all documents generated by the company. While the QMS module allows them to manage all the tasks of the quality system, ensuring that they are carried out correctly and on time. Cecilia became responsible for this project and today she is in charge of updating the digital quality management system.
The implementation was successful. Initially I, together with the quality manager, worked on the design of the processes and we did the tests to see how it worked. Then we did staff training and received great feedback.
Approved by ANMAT, Felsan has the Good Manufacturing Practices certification, which standardises safety in operations and guarantees an infrastructure that complies with legal requirements.
GMPs are a basic tool for continuous improvement in order to obtain safe products for human consumption, focusing on hygiene and handling. Below, we highlight some of the benefits related to this certification:
Automation is an inevitable step in GMP. This is done primarily to prevent people performing manual or repetitive tasks from wasting valuable time and resources.
With the integration of the modules offered by Loyal Solutions , we have facilitated this client's GMP certification.
Through the child forms of the QMS module and the download of pre-designed reports, we were able to link all the documents as we did on paper. Each stage of the process has one or more documents in DMS that in turn are linked to a QMS form, which refers to the QC analysis record of that product.
The Loyal Solutions QMS module allows you to reference Loyal DMS documents. In this way, it is easy to relate documents and different types of forms and establish the relationships between them. In addition, it has customisable workflows with best practices for compliance with quality, safety and occupational health standards.
We put together a great network with the help of both modules. The static part is in DMS, while the dynamic part is in QMS.
And then she adds:
We keep records and link references from raw materials to the final product. The production, quality and technical departments are involved. At Loyal we have the whole process from reception to dispatch, going through all the stages
Cecilia explained that software validation in the pharmaceutical industry is extremely important. All computerised systems and their life cycles require validation to confirm that the quality and safety of the products are in accordance with the requirements of regulatory entities, which is of utmost importance for the safety of medicines.
We validated the system internally because it is a requirement we had to comply with ANMAT codes.
This year Loyal Solutions launched a new product based on its own feedback and that of the system's users: Loyal 6. Its main objective is to improve the user experience while preserving its behaviour. This new product, more efficient and intuitive, allows a better use of space, better navigability and gives more relevance to the content.
I attended the Loyal 6 webinars. We noticed that the new interface makes it easier to link the DMS and QMS modules. That's great for us, it would be very useful to see everything together. We will make the transition as necessary, we want it to be updated. We definitely see a lot of potential in the new version.
Finally, Cecilia tells us that in the context of the pandemic they had no problems using the system. She mentioned that an internal comment among them is “It's good that we decided to digitise at that time, the work done during all these years could not have been done if we were using paper”.
I would highly recommend Loyal to other companies. It is a very convenient and easy to use tool. It is an excellent solution to optimise working time.
Do not lose control of your processes and manage your business documents.