It can be a challenge for life science companies to find an IT operations provider who understands and meets the regulatory requirements. Swedish Replior, the company behind Trial Online, managed its own operations for many years. But for the past two years, the sister company Complior has been responsible for IT operations.
– Trial Online is a data collection software platform that has been used in clinical trials worldwide for over 20 years. Our customers are subject to strict regulatory requirements in the EU and the USA, among others, says Christer Nilsson, CEO of Replior.
Three years ago, the Replior Group acquired an IT operations operator with extensive experience from another strictly regulated industry, fintech.
– We have extensive experience of IT operations in the fintech industry with its extensive requirements for IT security, data integrity and compliance. With Replior’s expertise, we have now further developed our business to also map directly to the regulatory requirements set in life science, says Ronnie Johansson, Deputy CEO of Complior.
An ISO certified supplier is not enough. A couple of overall points to keep in mind when procuring IT operations are the following:
- Does the supplier have a quality management system adapted for life science?
- How does the supplier document its infrastructure and customer delivery?
- There is traceability for all events in the IT environment?
- Can the supplier perform a formal audit or inspection by authority?
- How is data stored so that the GDPR is complied with?
– Today we are a unique supplier of IT operations for the life science sector, concludes Ronnie Johansson.