Genzyme

post image

Quality Management at Genzyme optimised

A pharmaceutical company has to deal with strict quality demands and regulations. No wonder, as a mistake during a medicine’s production process can have disastrous consequences for public health. That is why process descriptions, work instructions, procedures and guidelines go through an extensive approval cycle before they get an official status. The Flemish location of the international pharmaceutical company Genzyme has digitalised that approval process, which shortens the run time considerably. The results are so positive that the other global Genzyme locations are interested in adopting the Flemish approach.

By origin the pharmaceutical company Genzyme is an American firm, with its headquarters in Boston. With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences to address a range of unmet medical needs. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, transplant and immune disease, cancer, and diagnostic testing. Genzyme’s commitment to innovation continues today with a substantial research and development program focused on genetic diseases, immune system disorders, heart disease, and cancer.

Genzyme operates according to the so-called Good Manufacturing Practices (GMP). This quality standard is about recording precisely how and under which circumstances a product, in this case a medicine, has been made. The idea is that a medicine’s quality can never completely be determined by analysing its chemical construction. The quality can only be guaranteed when the production process is carried out in an accurately prescribed and controlled way. For Genzyme this means that new or changed documents have to be read, approved and signed by three different officials before they reach an official status.

Lost

The Genzyme location in the Flemish city of Geel has recently decided to digitalise the approval process. The most important reason was that the process took up too much time. Katia Vermeulen, QA Systems Officer Livelink at Genzyme: “It happened more than once that a document had to be signed by someone who just went abroad. Then it could take a month before the document was completed with his signature. Also, we sometimes lost documents, both drafts and signed documents. That did not do the efficiency any good.”

All Genzyme locations use OpenText’s Livelink for the creation and maintenance of an electronic archive. As that solution also offers functionality for workflow and compliance, an extension was the most obvious choice. “And it soon became clear that choosing Morningstar Systems as our implementation partner was just as obvious. They were the only party that stayed within our available budget and timeline. Besides that we thought it would be a great advantage to do business with a local party, so that in case of an occurring disaster we would not be confronted with a time difference”, says Vermeulen.

E-Signature

Thanks to Livelink, the documents, like procedures, guidelines and work instructions, are now distributed electronically for approval. The approval is confirmed with an electronic signature. “Such an e-signature has the same value as a ‘real’ signature”, says Vermeulen. Livelink makes sure that documents no longer get lost. The paper use has decreased and the run time is much shorter. “When it is really necessary a document can now be implemented in one day. Before, that was impossible. The employees are convinced of the value of the system, especially because all the documents can now easily be found. Digitalisation is especially beneficial when someone is abroad, which happens often in a large international company like Genzyme. Livelink assures that the approval process is no longer slowed down because documents have to be sent by mail or someone’s return to Belgium has to be awaited.”

The cooperation between I.R.I.S. and Genzyme is very good, according to Vermeulen. “I am very positive: they do what they promise and they are reliable. Every year I.R.I.S. conducts a new project with us, so the cooperation stays very intense. Obstacles or problems have not yet occurred.”

Preferred

Genzyme has plans to further elaborate the use of Livelink. For example to support the implementation of a ‘change control’ program, which involves new workflows and forms that have to be approved officially. Livelink has to make sure that everything stays compliant with the GMP-guidelines. Other Genzyme locations in Europe and the United States are also interested in applying Livelink for workflow management. “Based on our positive experience they will probably also choose Morningstar Systems. I expect that I.R.I.S. will eventually reach the position of preferred consultant within the whole Genzyme organisation”, says Vermeulen.

Leave a Reply

Your email address will not be published. Required fields are marked *