Client Story

ABOUT FRESENIUS KABI

Fresenius Kabi is an international healthcare company specializing in medicines and technologies for infusion, transfusion, and clinical nutrition. It has more than 20 years of experience in home care and more than 70,000 home clinical nutrition patients worldwide, and in Argentina it is the largest company offering a full range of clinical nutrition and the equipment to administer it. Its NutriHome business provides home clinical nutrition services through teams of specialized healthcare professionals.

In this highly regulated environment, quality, safety, traceability, and regulatory compliance are essential, and so is keeping all company documentation in a single, organized system.

MOVING FROM MANUAL TO DIGITAL

Before LOYAL, Fresenius Kabi and NutriHome managed documentation through paper files, shared folders, and Word and Excel files. That approach wasn’t efficient, especially for audits, and as the volume of documents grew, tracking each one from draft through review and publication became harder.

“Our main objective was the traceability of information,” Cinthia says. “We needed good follow-up of a document’s steps, from the draft stage until it is revised and published. Up to that point, we had been managing it in an Excel spreadsheet that we kept modifying. Doing it manually brought us many errors, given the number of documents we had to handle.”

ONE SYSTEM, TWO ORGANIZATIONS

Fresenius Kabi implemented LOYAL DMS to centralize its documentation and control the document lifecycle. Today, about 700 documents are managed for Fresenius Kabi and another 300 for NutriHome, with documents from every area in the system. Each area has a trained person responsible for its own procedures.

The two companies each manage their own documents on the same platform, with access controlled by scope. If one needs to see the other’s documents, it asks for authorization. Cinthia took part in the implementation at Fresenius Kabi and now administers the system at NutriHome, and together with the administrator at Fresenius Kabi she manages the documentation of both companies.

“The support we got was very good,” she says. “The consultant, Luis, helped us a lot with everything we needed. It was a complex process, as we had to adapt all our documents to a new format, but in the end we managed to get all areas of the company involved in the system.”

VALIDATED FOR A REGULATED INDUSTRY

Software that supports activities governed by Good Practices has to be validated. Requirements from regulators including ANMAT, FDA, EMA, INVIMA, COFEPRIS, and ANVISA call for validated, maintained systems in this kind of environment. LOYAL advises its customers on validating its products with experts in computerized-systems validation.

At Fresenius Kabi, the company’s own validation committee took on that work and completed it successfully.

KEEPING DOCUMENTATION ACCESSIBLE

When the COVID-19 pandemic moved teams to remote work, Fresenius Kabi and NutriHome kept working the same way. Each user could reach the documentation they needed quickly and easily.

“Those of us who do administrative work, we work 100% home office. It was much more practical for us not to have to print documents ourselves and distribute them to the different areas. Everyone could log in from their own computer and generate their own uncontrolled copies. To be honest, it was very beneficial in this pandemic context.” — Cinthia Servino.

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