Formpipe, inc. 1200 US Highway 22 E Suite 2000 Bridgewater, NJ 08807 Tel : +1 908 399 7828 Email
2 Burlington Park Station Road, Foxton Cambridge - CB22 6SA Tel: +44 1223 872747 Email
Unit 1, Isaac Newton Centre Nottingham Science Park Nottingham – NG7 2RH Tel: +44 115 924 8475 Email
Science for a good life – Technology for a robust business
Probi is a research and development company with a focus on developing robust probiotics that withstand tough manufacturing processes and meet customer requirements. Founded in 1991, the company has grown quickly and now employs 37 people at its head office in Sweden and has customers all over the world. Working with leading consumer brands including Danone and NBTY, and with over 100 patents on bacterial strains, Probi specialises in the safe and compliant research and development of consumer health care and functional food products that contribute towards a range of health benefits. These include improved gastrointestinal health, a stronger immune system and improved nutrient uptake. Probi also boasts the bestselling functional fruit drink in Sweden, ProViva.
Quick & Easy
Off-the-shelf, user-friendly solution which was developed and implemented within the business quickly and efficiently.
Expandability and scalability means the new platform can be adapted to meet the changing needs of the organisation.
Safe & Efficient
Effective and safe document management with fast and controlled access, boosting traceability and compliance and improving organisational efficiency.
Traditionally Probi managed its quality control and compliance management using a folder-based computer system to store, access and amend technical documentation. Changes to the status of saved documents were often communicated via post-it notes, verbal conversations or email.
During a review of the existing approach to quality control and document management, and in a bid to future-proof Probi’s ongoing success, several potential risk factors were identified. The first potential risk related to version control; it was commonplace for documents to be duplicated on the folder system, which could lead to outdated information being presented to customers.
The second key risk factor identified related to the speed of access. The folder system, originally designed to support a handful of customers, was making it cumbersome to locate specific documents, it lacked order and organisation and meant staff spent unnecessary time searching for what they needed.
The third risk factor was that of visibility. Using a folder system alone couldn’t provide staff with insight into who else had accessed or amended or even deleted any given document. Probi recognised the need to adapt its business processes to meet the increasing demand and ensure its operations continued to be world-class and compliant.
The Solution – Platina LS
Migrating quality control and document management processes to a more intuitive system was a prerequisite to Probi’s ongoing success. As such, Probi began the process of researching the various solutions available on the market.
An initial task was to scope out Probi’s requirements and build a business case for purchasing an Electronic Quality Management System (EQMS). Essential functionality included:
The ability to access documents quickly via a searchable storage system
Quick access to a document’s full life cycle – from creation to deletion
Clear version control protocols to protect against duplication
Competitive price point
Access to localised IT support
To ensure due diligence, Probi received demonstrations from a number of software vendors before selecting Sigma and the EQMS Platina LS by Formpipe. One of the key qualities of the Platina LS platform that contributed to Formpipe’s selection was the fact that Platina LS has been developed for use specifically within the life science sector. As such, the software provides full support for meeting the associated regulatory compliance. Additionally, the ability to gain control and visibility over all customers’ interactions with documentation was hugely appealing.
Commenting on the selection process, Sigma consultant, Michael Lauridsen, said: “Probi identified a need to move away from its traditional method of controlling documentation but with a limited IT resource in-house was, like many organisations, unsure of what the new method needed to look like and how best to go about selecting the most appropriate application. Probi was investing in the future of its business so took a very serious and scientific approach to scope out its exact requirements, building a strong business case and reviewing a wide range of EQMS products on the market.”
Before the implementation phase could begin, Sigma mapped out the proposed roll-out, along with additional requirements including staff training, and agreed on a project timeline. In February 2015 a two-day workshop took place for core personnel at Probi. The workshop was coordinated by Sigma and was successful in ensuring key features and functionality were communicated effectively.
In the summer of 2015, Probi began implementation of Platina LS. Thanks to many of its functions being pre-configured – and as a result of Sigma’s project management expertise – the system went live within just 37 days. Although the system has only been live for a few months, it is already delivering noticeable benefits to Probi as technical product manager, Emma Årsköld Lind, PhD, explains: “The implementation of Platina LS was really smooth and straightforward. Michael from Sigma was on hand throughout the introduction of the software so the transition from our legacy folder system was very efficient.”
Now fully embedded and operational, Platina LS is empowering Probi to dramatically reduce the time it takes to locate documents. What typically would take several minutes can now be achieved in seconds, thanks to the system’s search functionality, enabling Probi to operate more efficiently and improve service to customers.
Platina LS provides Probi with complete control and visibility over a document’s history. With the system now in place, Probi can be certain of which documents customers have or have not been sent, when and what changes have been made and who made them. Document duplication is no longer a concern for Probi so staff can have total faith that the version managed within Platina LS is the most up-to-date and correct version available. This is supporting better data integrity practices and is ensuring Probi’s growing customer-base receives the right document first time, every time.
Emma adds: “We’re now fully up and running with Platina LS and the difference is like night and day. It is now much quicker to locate technical documentation, which as a small team makes a big difference to our overall productivity. 2015 was our most successful year to date and we are hoping to do even better this year. We view Platina LS as a solid foundation upon which we can build a really strong, safe and efficient business. Now it’s in place and being used, we can enter into new markets, expand our business and our number of customers without compromising the high standards of care and service that have become synonymous with Probi over the years. I would recommend Platina LS to any organisation looking for a highly intuitive, effective, reliable and user-friendly EQMS.”
Platina LS is proving popular as a replacement tool for managing and sharing documentation with customers. So much so that Probi is looking at how it can harness the platform to enhance processes in other areas of its business. The lab is one area that has been identified as a department that could benefit from the system’s analytical capabilities; with Platina LS likely to be used to create automated deviations reporting in the near future.
In response to the system’s scalability, Michael describes the EQMS journey as a “never-ending story” and is currently discussing the potential of using Platina LS to better manage the company’s agreement handling processes. This will empower Probi to view the data behind the document and receive push notifications and reminders when agreements are applicable for renewal, for example. There is also scope for Platina LS to facilitate the use of electronic signatures.
Commenting on the future plans, Emma said: “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 gastrointestinal 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 is everything we wanted in an EQMS and as such, we feel confident that our business is future-proof and ready to take on the next chapter of its growth journey, supported by reliable, intelligent and value-adding technology.”
Probi will also benefit from regular software upgrades and ongoing support as part of its service agreement with Sigma. Commenting on the implementation, managing director of Formpipe Life Science, Keith Williams, 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 – Probi personnel are now 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 case management related documentation I have no doubt that those plans will be realised.”