Customer Story: Labatec
Labatec Pharmaceuticals is a privately owned Swiss-based company. For over 50 years, they have been delivering products for the hospital and retail sectors to European and Emerging Markets. Labatec operates out of Switzerland, and has an operational and commercial presence in Portugal and the MENA region, with over 80 products in its portfolio.
In 2019, Labatec opened a state-of-the-art facility in Sintra, Portugal, to manufacture oral solids products. In addition, it expanded its activities to include contract manufacturing (CMO), providing full manufacturing services in the EU for solid oral dosage form products.
Labatec’s new manufacturing site has to deal with local EU health authority requirements, Swiss-market requirements, and some specific requirements for customers in MENA countries. Also, as a CMO, it has to support many different customer requirements. As a company focused on customer satisfaction, Labatec needs to ensure it can easily address customer requirements and meet audits.
Mara Doria is the Quality Assurance Manager at Labatec . Managing a team of six, she is responsible for quality assurance for the manufacturing site, including batch and release, compliance with requirements for inspection readiness, and readiness for customer audits. In accordance with company processes and procedures, she also manages the quality systems and supports health inspections, as well as KPIs (key performance indicators) defined by senior management.
The Document Management Challenge
Doria explained that the company was facing challenges with managing documentation. Labatec is a multinational company that was managing documentation for multiple sites with a paper-based document management process. A lot of their documentation was shared between sites, so every time they changed the documentation (which happened frequently), they would have to scan the documents and send a PDF to the other sites to complete the approval flow. As a result, the revision and approval of documentation required a long time and lacked compliance with new data integrity expectations.
This process was not in compliance with the expected guidelines, and the company wanted to adjust the way it worked with documents so that the process became more efficient and the company will be in compliance. They decided to move to an electronic document management system (DMS).
The Hunt for a True Partner
Labatec put together a team to select a DMS vendor. It included key players from the manufacturing site (including Doria’s team), the quality team from Labatec Pharma in Switzerland, a validation engineer responsible for the control system validation, and senior management.
The selection team developed a list of requirements. Then, it reached out to many vendors in the market, including Master Control, Veeva, local suppliers, and startups, to try and understand which ones could deliver what they needed. Scigeniq was recommended by a senior management team member who was familiar with the company and its solutions, and Doria added them to the list.
The final decision to go with Scigeniq’s DMS solution was based on the flexibility to develop together a product configured to their needs. Because Labatec is a growing company, it wanted to work with a supplier that was also growing and was willing to work closely with them to ensure the DMS could provide the functionality and configurations they needed. Labatec was often the first to test new features and services of the Scigeniq DMS, ensuring the solution would work as needed.
Equally important were the qualifications of Scigeniq’s professional services team. Doria said that one of the requirements they identified was the skillset and qualifications of the vendor’s technical team. She said they wanted to work with people with in-depth pharma experience and strong IT and cybersecurity technical expertise.
The Benefits of Scigeniq DMS
In 2021, the DMS went into production with Scigeniq DMS, and, according to Doria, it is fulfilling all their expectations. She said the end users are very happy with the solution, and it has greatly enhanced data integrity by improving the management of time and resources.
The DMS has improved document review and approval processes. For example, they can now easily report on how long it‘s taking people to acknowledge documents, the length of the review and approval process, and other key performance metrics. It also ensured end users were accessing the last version document released and decreased the number of paper copies printed.
Doria said that one of the benefits of working with Sciqeniq’s professional support services team is getting help with new reports. Working with multiple customers frequently means needing a new report or new information, and the Scigeniq team supports Labatec with configuration or development as needed.
What’s Next for Labatec and Scigeniq
Based on their experience with Scigeniq DMS, Labatec is now expanding its use of Scigeniq solutions.
Labatec is implementing Scigeniq’s Regulatory Management System (RMS) and Quality Management System (QMS). In addition, Labatec is working with Scigeniq on additional modules, including Training Management (TMS) and Laboratory Management (LMS), as part of its product roadmap strategy.
The ultimate goal for Labatec is to create a connected set of solutions that provides a complete overview of all processes and enables the efficient use of resources, supporting the company’s continuing growth and expansion.