EXTEDO GmbH

Regulatory Information Management & eCTD Software Solutions and Services for Life Sciences

EXTEDO GmbH

EXTEDO is a leading provider of software solutions and consulting services for the regulatory affairs of medicines, medical devices and plant protection products (Regulatory Information Management). Currently, more than 700 customers in 60 countries trust EXTEDO's solutions, from small and medium-sized enterprises to multinational corporations. In addition, the company, which is headquartered in Ottobrunn near Munich, provides EURS, a standard system for validating, reviewing and approving applications for medicinal products, which is used by more than 30 regulatory authorities around the world.

The company employs more than 115 employees worldwide as well as numerous additional external consultants on site. EXTEDO uses the cloud-based software solution ZEP - time recording for projects - from provantis IT-Solutions for time recording of project orders and invoicing.

Trend towards the "shared economy" in the pharmaceutical industry

"We have been experiencing a trend towards the shared economy in the pharmaceutical industry for twenty years now," explains Elmar Weber, looking back at the company's history to date. As Chief Financial Officer (CFO), he is responsible for all corporate services (HR, Finance, Legal and Corporate IT) at EXTEDO. "We were able to play a significant role in the first phase - the transition from paper-based to electronic admission procedures - with our solutions. And EXTEDO is also involved in the second phase, the digitalisation of the very complex admission procedure, and is developing a cloud platform for all project partners involved in the process.

Especially in the early days, the company received large development contracts that were billed on a time basis. The combination of Microsoft Access database, Excel lists and Word documents used for time recording and accounting at that time quickly reached its limits. Even though he was not yet employed by EXTEDO at the time, Elmar Weber knows from stories: "Aggregating the numerous documents at the end of the month in order to be able to create the invoices from them proved to be very time-consuming and error-prone. For this reason, the decision was made in 2007 to look for a special solution for time recording."

Within the scope of a corresponding research with a subsequent selection process of various providers, EXTEDO finally decided to use the ZEP solution. ZEP stands for time recording for projects and was developed specifically for use in project-oriented companies.


Time recording and more: ZEP in use at EXTEDO

EXTEDO currently uses ZEP not only for pure time recording, but also for the modules "travel expense accounting" and "holiday and absence management". In addition, invoicing is carried out via the ZEP module of the same name. For this purpose, the times recorded in ZEP are automatically transferred to the invoice. The data is then transferred to financial accounting via the DATEV interface available for ZEP. "Due to our international activities with branches in the USA and China and projects all over the world, there is of course extensive travel activity that has to be managed accordingly," Elmar Weber explains the use of the individual modules. "The DATEV interface was essential for us to ensure a seamless data transfer to the financial accounting system.

As an operating model for the use of ZEP, EXTEDO opted for operation in the cloud model. Elmar Weber explains: "We have already been pursuing a 'cloud only' strategy for several years, i.e. a software solution is only purchased if corresponding cloud use is possible. We simply don't want to have to worry about operating the application." However, data security and data protection play an important role. After all, extensive confidential data is also involved in an approval procedure in the pharmaceutical industry. "For this reason, we check the data protection measures of each of our software suppliers very carefully," confirms Elmar Weber.

As a "Cloud Service Made in Germany", ZEP is operated in a certified (ISO 27001, IT basic protection) high-performance data centre on a fully redundant, highly available server cluster in Germany. The internet connection to the ZEP servers is provided at 1000 Mbit/s via redundant fibre optic lines. The usage contract concluded between ZEP customers and provantis naturally also includes the contract for order processing that has been mandatory since the EU Data Protection Regulation (DSGVO) came into force.


"Never Change A Running System" plus first-class support

In the meantime, ZEP has been in use at EXTEDO for more than ten years. Elmar Weber sums up: "Time recording is generally not a very popular topic among employees, so user-friendliness is an important prerequisite for acceptance. In the past, there were certainly one or two suggestions to look for an alternative. However, I have to admit that we haven't found anything better than ZEP." Moreover, the system has proven to be extremely stable so far.

"ZEP runs and runs and true to the motto 'Never change a running system' we see no need to change anything at the moment."

Elmar Weber, Chief Financial Officer (CFO)

Elmar Weber gives top marks to the ZEP support: "The support for the solution is really great. On the one hand, a clear product development strategy is apparent at provantis. The company knows exactly which change requests will be implemented customer-specifically and which will be included in a future release, while keeping an eye on the aspect of standardisation, which is important for us in cloud use." In addition, according to Mr Weber, the company always proves to be a contact partner at eye level: "With every call, it is immediately clear that there is someone at the other end who is intensively dealing with the solution."

Conclusion of the satisfied EXTEDO CFO:

"If I were to choose time and attendance again today, I would choose ZEP for the support alone."

Elmar Weber, Chief Financial Officer (CFO)

EXTEDO GmbH

Einsteinstrasse 30
85521 Ottobrunn