“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
FELSAN
Client Story
ABOUT FELSAN
Felsan S.R.L. specializes in the import, manufacture, and fractionation of laboratory and haemotherapy supplies. The company manufactures REDIAR in-vitro diagnostic reagents at its Buenos Aires plant, operating under Good Manufacturing Practices (GMP) and ANMAT requirements.
MOVING FROM PAPER TO DIGITAL
In 2017, Felsan began moving away from paper-based processes. The company needed a digital system to improve management, communication, and collaboration across the areas involved in its quality processes.
By 2018, Felsan was evaluating solutions to support the digitization of its processes, with one requirement in particular shaping the search:
“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 wasn’t even being talked about yet.”
— Cecilia Santín
CONNECTING QUALITY MANAGEMENT
Felsan selected LOYAL and implemented both DMS and QMS. The project included process design, testing, and staff training, with Cecilia working alongside the Quality Manager to define and test the processes before training the wider team.
DMS — Document Management
Centralizes and controls the documents generated throughout the company’s processes.
QMS — Quality Management
Manages and tracks quality activities, forms, and workflows.
DMS + QMS — Working Together
Felsan uses both modules to connect documentation with the quality processes and records managed across the organization. Documents in DMS can be linked to QMS forms and processes, creating greater traceability across Production, Quality, and Technical areas — from raw materials through to the final product.
SUPPORTING GMP REQUIREMENTS
Felsan internally validated the LOYAL system to meet its requirements under ANMAT regulations. The system supports controlled documentation, linked records, and structured quality processes within the company’s regulated environment.
DIGITIZATION THAT PAID OFF
When the COVID-19 pandemic arrived, Felsan was already working digitally.
“It’s good that we decided to digitize at that time — the work we’ve done over all these years couldn’t have happened if we were still using paper.”
— Cecilia Santín
Could LOYAL support your regulated quality processes?
Bring documentation, quality processes, and records together in one centralized platform.
