Proteos Biotech achieves audit readiness and enhanced compliance with Scilife’s eQMS

About Proteos Biotech

Founded in 2010, Proteos Biotech is a leading biotech company that researches and produces recombinant enzymes for biomedicine, pharmaceuticals, and cosmetics. Based in La Mancha, Spain, Proteos Biotech has established itself as a benchmark in its field by continuously innovating and developing exclusive, high-quality products for its clients. Their expertise extends to providing Contract Manufacturing Organization (CMO) services, focusing on meeting the highest regulatory standards.

Maria Vendrell Moreno, QA Manager, and Jorge Caño Martinez, Quality Assurance Technician at Proteos Biotech, recently met with Fabiola Samueli, Customer Success Representative at Scilife to discuss their journey with Scilife’s eQMS and how it has revolutionized their quality management processes.

The Search

As Proteos Biotech expanded, the limitations of their paper-based system became increasingly apparent. The need for better document traceability and audit readiness led them to seek a more efficient, digital solution. The team recognized that a robust eQMS would help them comply with industry standards and drive continuous improvement across their operations.

Jorge, who oversees document management, explained:

“Before using Scilife, we stored all our documents in paper archives. Retrieving specific SOPs during audits was time-consuming, and we were constantly running out of storage space.”

The decision to move from paper to Scilife’s digital eQMS was a clear choice, as Maria noted:

“We needed a system that integrated all aspects of quality management in one place, and Scilife was the perfect fit for our growing needs.”

The Set Up:

Proteos Biotech’s transition to Scilife was seamless, thanks to the system's intuitive design and the comprehensive support from the Scilife team.
Maria emphasized the smooth integration:

“The implementation process was well-organized, and the technical support was excellent. Scilife provided all the necessary training, which helped us quickly integrate the system into our workflow.”

Proteos Biotech also integrated CAPA management, deviations, and change control into their operations, starting with the document control and training modules. The team is excited about future expansions to additional modules.

Jorge added:

“The system is very user-friendly, and the dashboard provides a clear overview of tasks and pending actions, making our daily operations more efficient.”

Favorite Features

Maria and Jorge highlighted several Scilife features significantly improving their workflow and compliance.

One of Jorge’s favorite features is the document control module, which has streamlined how Proteos Biotech manages and retrieves SOPs and other key documents:

Maria noted how the dashboard functionality helps the team stay on top of their tasks:

“The dashboard allows us to see pending actions at a glance. It’s intuitive and helps us keep everything organized across all departments.”

The audit trail and version control functionalities were praised for ensuring transparency and accountability across all quality-related activities.

Expert Advice

Maria and Jorge enthusiastically agreed when asked if they would recommend Scilife to other organizations. Their advice to other companies considering implementing an eQMS is simple: start as soon as possible.

Jorge advised:

“If you have the opportunity, begin with a digital system. Transitioning from paper is challenging, but Scilife has made it manageable and worthwhile.”

Maria added:

“Proper training and planning are key. Make sure to take advantage of Scilife’s test environment before fully transitioning. It makes the process smoother.”

The Results

Proteos Biotech has seen tangible results since adopting Scilife’s eQMS. The move to a digital platform has improved document management and transformed their audit readiness and compliance with industry regulations.

Jorge highlighted the time saved during audits:

“Before, it could take hours to locate specific documents. Now, we can find them in seconds, which has made our audits much smoother and less stressful.”

The transition to Scilife’s digital platform has also enhanced collaboration between their various sites across Spain, streamlining communication and reducing the risk of errors.

Maria summed up the experience:

“Scilife has made compliance much easier. During audits, external auditors are always satisfied with how quickly we can present validated documentation.”