Software validation is critical for this type of industry. At Fresenius Kabi, we have a validation committee that took on this task and it was successfully completed. The fact that Loyal Solutions is a validated software brings great value to our organisation. 

FRESENIUS KABI

CINTHIA SERVINO

Quality Analyst at NutriHome – Fresenius Kabi S.A

FRESENIUS KABI

From Loyal Solutions we would like to present a new testimonial from one of our clients: Fresenius Kabi , an international healthcare company specialising in life-saving medicines and technologies for infusion, transfusion and clinical nutrition.

The company has more than 20 years of experience in home care and more than 70,000 patients worldwide with home clinical nutrition. Fresenius Kabi is the largest company in the country with the ability to offer a full range of clinical nutrition and medical equipment for its administration. Thus, it helps to improve the nutritional condition of patients and accelerate the recovery process.

Optimal quality and safety standards, the efficacy of its products and services and regulatory compliance are fundamental prerequisites for fulfilling its purpose. For this reason, it is necessary that all company documentation is recorded and organised within a single system to achieve continuous improvement.

On this occasion, we interviewed Cinthia Servino , Quality Analyst and Administrator of the Loyal Management System at NutriHome , a Fresenius-Kabi S.A. company dedicated to Home Nutrition Support, covering all aspects of the practice through teams of specialised professionals.

The company was looking for a management system that would allow them to optimise the processes of their organisation in a quick and agile way. Cinthia tells us that at that moment they were handling all the information manually, either on paper or in shared folders with Word and Excel files, and that this was not efficient when it came to audits.

With a large volume of documents, it was necessary to acquire a system that would allow them to improve the organisation of information and the tracking of their processes. For this reason, the company decided to implement Loyal’s document management system , which guarantees the traceability of its documents and ensures that all information is stored in a single centralised database.

 Our main objective was the traceability of information. We needed to achieve good follow-up of the steps of a document, 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 were modifying. Doing it manually brought us many errors due to the number of documents we had to handle.

Currently, Fresenius Kabi manages approximately 700 documents in the Loyal DMS module. Moreover, NutriHome has a further 300 documents uploaded to the system.

In both companies, documents from all areas were incorporated into the Loyal Solutions management system . Each one of them has a person responsible for managing the procedures in their area of work. In this way, all the information is centralised within the same system, which means an increase in effectiveness and a reduction in costs for the company.

The implementation was successful. The support we got from you was very good. 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.

Cinthia was involved in the implementation of Loyal at Fresenius Kabi and is currently responsible for the administration of the system at NutriHome. Together with the administrator at Fresenius Kabi, they manage the documentation of both companies.

NutriHome is a home clinical nutrition service within the national territory for all patients with parenteral nutrition or enteral nutrition by tube or ostomy.

Through a system of scopes, only authorised users can access the required information. This makes it possible to manage both companies by defining the scopes for each document according to who must intervene or read a given document.

The system is very simple and intuitive. In both companies we work with Loyal. Each one handles its own documents and if one company needs to see the other company’s documents, we ask for authorisation to be able to view these documents. It was very useful for us because we had all the documentation on paper and the tool makes our work much quicker.

Another important aspect for the company when implementing the management system is its validation. The main objective of the validation of computerised systems is to provide documentary evidence that ensures that the system works in accordance with its intended use, previously determined and approved by the organisation.

If the software is involved in activities regulated by Good Practices , it must be validated. Validation is part of the organisation’s quality system and makes it possible to follow the selection, implementation, use and retirement phases of computerised systems.

Requirements from ANMAT, FDA, EMA, INVIMA, COFEPRIS, ANVISA require validation and maintenance of all laboratory systems, so we provide advice to our customers to validate Loyal Solutions products with experts in validation of computerised systems, control and quality systems for IT areas of different industries.

Software validation is critical for this type of industry. At Fresenius Kabi, we have a validation committee that took on this task and it was successfully completed. The fact that Loyal Solutions is a validated software brings great value to our organisation.

During the pandemic, Cinthia explained that they were able to continue working from home without any problems. Each user was able to access the necessary documentation quickly and easily.

In addition, Cinthia told us that she participated in one of the courses developed by one of our consultants. She assured us that she found the administrative tools course very agile and useful.

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.

Fresenius Kabi’s products and services help provide care for patients in critical and chronically ill conditions. For this reason, they place great importance on the high quality of their products and services to ensure the efficiency of medical care.

From Loyal Solutions , we thank the entire Fresenius Kabi and NutriHome team for allowing us to accompany them in this process of continuous improvement . We will keep working to meet all your expectations.