“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.”
Cecilia Santín, Founding Partner & Quality Assurance Department, Felsan S.R.L.
Cecilia Santín
PARTNER AT FELSAN S.R.L. QUALITY ASSURANCE DEPARTMENT
Client Story
ABOUT FELSAN
Felsan specializes in the import, manufacture, and fractionation of laboratory and hemotherapy supplies. It sells in vitro diagnostic reagents under the REDIAR name, manufactured at its plant in the Autonomous City of Buenos Aires, which is authorized by ANMAT, Argentina’s national medicines, food, and medical technology agency. Felsan holds Good Manufacturing Practices (GMP) certification approved by ANMAT.
MOVING FROM PAPER TO DIGITAL
In 2017, Felsan began moving away from paper. The company wanted a system that would make it easier for all the areas that interact with each other to manage their work, communicate, and collaborate.
In 2018, the search for a digital system began, and one requirement shaped it:
“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 digitization of processes, which at that time wasn’t even being talked about yet.”
— Cecilia Santín
A PROJECT LED FROM WITHIN
Felsan implemented LOYAL DMS and QMS. DMS manages all the documents the company generates, and QMS manages the tasks of the quality system, making sure they are carried out correctly and on time.
Cecilia, a food technologist who has always worked in quality management, became responsible for the project and today keeps the digital quality system up to date. “Initially I, together with the quality manager, worked on the design of the processes and we did the tests to see how it worked,” she says. “Then we did staff training and received great feedback.”
DMS + QMS, WORKING TOGETHER
Using QMS child forms and pre-designed reports, Felsan was able to link its documents the way it had on paper. Each stage of a process has one or more documents in DMS, linked to a QMS form that refers to the QC analysis record for that product.
“We keep records and link references from raw materials to the final product. The production, quality, and technical departments are involved. With LOYAL, we have the whole process from reception to dispatch, going through all the stages.” — Cecilia Santín
SUPPORTING A REGULATED INDUSTRY
Cecilia stresses that software validation is extremely important in the pharmaceutical industry. Computerized systems and their life cycles have to be validated to confirm that quality and safety meet what regulators require. “We validated the system internally, because it is a requirement we had to comply with under ANMAT codes.”
LOOKING AHEAD TO LOYAL 6
Cecilia 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,” she says. “We will make the transition as necessary. We want it to be updated. We definitely see a lot of potential in the new version.”
DIGITIZATION THAT PAID OFF
When the COVID-19 pandemic arrived, Felsan had no problems using the system. Internally, the team has a saying about the decision to go digital:
“It’s good that we decided to digitize 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 optimize working time.” — Cecilia Santín, Founding Partner, Felsan
Could LOYAL support your regulated quality processes?
Bring documentation, quality processes, and records together in one centralized platform.
