Nelson Labs Europe works more efficiently and is compliant – thanks to the expertise of Ordina
From blister packs for drugs to infusions and inhalers: every product that comes into contact with drugs must be tested for the presence of chemicals. Nelson Labs Europe, formerly known as Toxicon, is the market leader in research into these types of substances, known as ‘extractables’ and ‘leachables’. This research is carried out in strictly regulated environments. However, all computer systems and software used by Nelson Labs Europe must also be validated and the data generated by these systems must be stored correctly.
Natasja Bastiaens of Ordina helps Nelson Labs with quality and compliance: “Nelson Labs has to comply with a huge number of rules, regulations and standards. The FDA’s ‘21 CFR Part 11’, for example, determines how they must handle electronic data. They also have to comply with good manufacturing and good laboratory practices, which means they must comply with rules on the safety of pharmaceutical products and their packaging, carry out tests, validate computer systems and instruments and carry out calibrations in laboratories,” she explains. “Nelson Labs Europe called on us to help them optimise their validation processes.”
From assessment to training
After a discussion with the internal QA team and management, Natasja decided to start an assessment process to identify the gaps in the existing approach. Based on the results, she made a number of suggestions for improvement, which she prioritised in close consultation with Nelson Labs Europe.
The Ordina Q&C team has now become a fixture in the buildings of Nelson Labs Europe. Natasja supervises, coaches and provides training. She receives full support from senior management, which she believes is a must: “Every month, we sit down together to discuss the status and all future actions, and senior management helps us to raise awareness throughout the company. Not only the internal QA team but everyone at Nelson Labs needs to know which processes and (computer) systems have to comply with which regulations and standards and why. That’s why we not only provide awareness and training for the QA team, but for everyone within Nelson Labs. This way, awareness seeps in step by step and we can optimise every process.”
Everyone at Nelson Labs needs to be aware of which processes and (computer) systems have to comply with which regulations and standards and why. That’s why we provide awareness and training for everyone.
Tool to consolidate test results
Thanks to the positive experiences with Natasja and her colleagues, Nelson Labs also asked Ordina for help in developing a specific tool. “During their tests and analyses, Nelson Labs’ scientists collect masses of data, which they process into analysis reports for customers. Compiling these reports took a huge amount of time, because the information is scattered around various sources – from Excel files and paper documents to other computer systems. Analysis results were often retyped manually and there was a lot of duplication. This meant they lost a lot of valuable time with input, corrections and revisions,” says Rik Van Den Berghen, Q&C expert at Ordina. Ordina built a user-friendly application in Microsoft.NETcore technology to store the analysis results quickly and transfer them to reports.
Crossroads of competencies
To ensure that the application would meet all legal and quality requirements, Ordina had put together a team of developers and compliance specialists. Thanks to this ‘Regulated Development’ approach, the specific legal and quality requirements were taken into account right from the start of the development process. In this way, Ordina succeeded in validating and implementing the software on time. “We speak the language of companies such as Nelson Labs and are familiar with the legislation and standards. Compliance is completely ingrained in everything we do,” says Rik, who took care of the validation. “Our fellow developers are experts in software development. This integrated approach is Ordina’s strength: by combining our knowledge, we can offer our customers the very best solution.”
We speak the language of companies such as Nelson Labs and are familiar with the necessary laws and standards. Our fellow developers are experts in software development. This integrated approach is Ordina’s strength.