Leading probiotics research and development company, Probi, has selected software consultancy, Sigma, to implement the Platina LS electronic quality management system (EQMS) by Formpipe Life Science. Chosen to form part of the firm’s growth strategy and help futureproof its rapidly expanding operation, Platina LS is already in use following a brief 37 day implementation.

Brought in to replace a folder-based internal system of quality control and document management, the Platina LS platform has improved visibility over a range of technical documentation and is providing Probi personnel with a full audit trail of customer interactions with business critical documentation. Platina LS is also delivering a range of other benefits including speeding up the process of accessing and amending documents and reducing the risk of compliance failure by creating more efficient processes, whilst promoting strong version control.

With over 100 patents across multiple bacterial strains and an impressive growth strategy to both monopolise its existing market in consumer healthcare and Functional food and branch into further application developing, Probi’s technical product manager Emma Årsköld Lind, PHD was keen to select an EQMS application capable of delivering immediate benefits. Emma explains: “Probi is a visionary company and one that recognises the need to prepare today for the challenges of tomorrow. In the last few years our growth has been underpinned by both world-class research & development and clinical trials to identify and document bacterial strains that have the potential to contribute towards improved gastro-intestinal health, a stronger immune system and healthy iron levels.

“In order to continue to be at the cutting edge of probiotic development we felt it was necessary to implement an EQMS that’s proven in the Life Science sector and able to grow with our business. Platina LS stood out above other products on the market and I feel confident that it will streamline our document management and quality control processes considerably.”

Platina LS was selected following a thorough and competitive tender process and upon the recommendation of software consultancy, Sigma. As leading consultant, Michael Lauridsen comments. “Probi is a fantastic organisation to work with and took an incredibly serious and scientific approach to reviewing its need and scoping out its requirements for an EQMS. Platina LS was the natural choice for Probi and I’m proud to have played a role in futureproofing the business and delivering a highly capable and scalable system on time and on budget.”

Platina LS is an enterprise level solution that promotes regulatory compliance and supports Life Science businesses to meet FDA, Title 21 CFR Part 11 and EU Annex 11 requirements relating to data security, data integrity, traceability and electronic signatures. Commenting on the implementation, Keith Williams, managing director of Formpipe Life Science, said: “Despite being a relatively small company, Probi represents everything that’s great about the life science sector and embraces best practice at every turn. By adopting a tried and tested EQMS platform, Probi is demonstrating its commitment to pioneering safe and successful bacterial strains that will make a positive difference to consumers’ health.

“Because Platina LS is a Windows based platform, it’s familiar and straightforward to use. Once the system is live, Probi employees will be able to locate, access and analyse documents in seconds. Probi has impressive plans to expand its operation and with Platina LS providing a safety net for all document management related processes and quality controls, I have no doubt that those plans will be realised if not exceeded.  

“We’re very excited to be working with such an innovative organisation in partnership with Sigma and look forward to seeing what precise benefits Probi will derive from migrating its document management and quality control processes to Platina LS.”

Formpipe Life Science is the software house behind Platina LS and works with a range of regulated organisations to help simplify complex process and technology environments by delivering a combination of consultancy services and software products for document management, training management, quality processes, and Long Term Archive.