You won’t find a company like Contipro just anywhere. This Czech biotechnology company from the small village of Dolní Dobrouč in the Orlické hory foothills has been producing a substantial part of the world’s production of hyaluronic acid, widely used in pharmaceuticals and cosmetics. Contipro invests heavily in R&D, so more than a third of its 350 employees are engaged in scientific work. Since 2012, ALVAO has been helping Contipro manage their IT.
Hyaluronic acid plays an important role in skin renewal, the body’s hydration and tissue protection. That makes it highly desirable in the pharmaceutical and cosmetics industries. Contipro extracts hyaluronic acid from the cell walls of Streptococcus zooepidemicus bacteria, and it is subsequently sold as a powder, which processing companies use to make their medicines or cosmetics. However, Contipro does not only sell the raw material itself. Their solid research background allows them to supply services like lab analyses or the testing of finished products. Contipro has thus built a reputation as a company firmly grounded in science. Their more than 100 scientists are constantly exploring new uses for hyaluronic acid. As a result, the company comes up with a lot of innovations and owns a number of patents.
The pharmaceutical industry is one of the most stringently regulated in the world. Naturally, this also applies to the IT department, which ensures that the introduction of any system does not adversely impact production quality. The regulatory framework includes several directives on good manufacturing practice (GMP). Compliance with the Guidelines is supervised by the State Institute for Drug Control (SÚKL). For computer systems, including information systems, the most important directive is GMP Annex 11. The practical effects of regulations include, among other things, the need to validate every product-quality-related piece of software the company aims to bring into operation. Validation is one of the mechanisms that helps the company manage risks. Basically, it is the process that ensures the product has a controlled lifecycle and meets regulatory requirements.
How does such validation work? To start with, a requirements specification is drawn up, to define what the product should be able to do. The next step is risk analysis, as the main factor for scoping the validation. Based on the functional specification and the risk analysis, the validation of the system itself then takes place (its testing and verification). Validation takes place according to a set of validation scenarios. Scenarios that do not pass validation produce a list of deviations observed. The system is revalidated annually, usually by the quality management department. The purpose if this is to demonstrate that the system remains in a valid state despite all changes that have taken place since the last validation.
In the pharmaceutical sector the validation process is very demanding and makes the introduction of new systems more complicated. ‘We invest a lot of effort in validation,’ explains Jakub Kožnar, CIO at Contipro, ‘Which is why we pay close attention to selecting only trusted suppliers backed by excellent references and years of experience.’
At Contipro, they use both of our main products: Service Desk and Asset Management. As part of the implementation, consultant Jan Fiala helped with defining the service catalogue and provided feedback on IT processes. ‘One of the main benefits of ALVAO is delivering know-how along with the product. Every product is deployed in a certain context and it is good to be able to rely on a supplier who understands the given context,’ says Jakub Kožnar.
He was looking to resolve two classic problem areas by deploying Service Desk: To digitize paper requisitions, thereby simplifying incident and request entry for people in the business, and to better prioritize tasks for the IT team. However, the main benefit lies in the newly acquired scope for further progress in IT and other departments: ‘The reality is that with the introduction of the Service Desk, there have been more incidents and changes. And that’s a good thing. If you make it easier for people to report incidents, they are more likely to find the time to let you know,’ explains Jakub Kožnar. Before that, everything was in paper form. People find paper requisitions needlessly laborious and complicated. Rather than initiate some improvement or report an incident, they prefer to just get on with their work. That leaves IT half blind, unaware of a lot of things. That hampered progress. But once you simplify requesting, people are more motivated to report things. There are now over 80,000 requests regarding more than 20 services in the company, and ALVAO has brought benefits beyond the IT department.
Basically, the whole of Contipro is service-managed and ALVAO was from the onset geared up for widespread use across different departments (i.e. Enterprise Service Management). Also, for regulatory reasons, it is essential for the company that everything is registered and traceable. ALVAO is user-friendly and no information gets lost from it. With ALVAO’s help, the Finance Department now manages the supervision of orders. Marketing uses the Service Catalogue to order business cards, PR articles or graphics. They keep contract records in Asset Management and the R&D department also uses Service Desk. The Service Catalogue lets you do things like request the preparation of new chemicals, and directly in the request form stipulate the composition of peptides and the gram weight of the respective compounds. One area where ALVAO is particularly helpful is Maintenance Management.
At the heart of every production company are technological assemblies underlying smooth operation and uninterrupted production. It is thus highly important to quickly correct any defect, while also preventing future defects by scheduled equipment maintenance. When the maintenance issue was dealt with at Contipro, Jakub Kožnar offered his colleagues from the maintenance department an ALVAO product he had already found good for IT management.
They used Asset Management to model workplaces, machinery and its individual components. Objects in Asset Management keep their last maintenance date on record and the next due maintenance date is calculated. Based on this date, maintenance requests are then automatically created in the Service Desk. This ensures that timely preventive maintenance gets done. Maintenance tasks have a clear deadline and a responsible solver, and everything is consistently recorded, so there is an audit trail in the system. Once the request is resolved, the maintenance date is automatically written to Asset Management.
If the equipment malfunctions despite regular maintenance, any employee can report the incident to the Service Desk. In the request form, they directly select the affected machine (with photos to help) and the link to Asset Management is automatically logged to the system. The maintenance manager then sees that there are more incidents associated with some components than usual and can carry out another inspection based on this. The combination of both tools will thus ensure a firm foundation for the company’s maintenance process.
‘ALVAO progressively found its way into almost all our departments. Colleagues see that it works and want to reap their own departmental benefits. Being based on ITIL® principles, it naturally helps us meet regulatory requirements. The basic requirements arising from GMP are contained in the very principles of ITIL,’ sums up Jakub Kožnar.