In addition, own auditors must be regularly qualified and trained. If an external service provider is commissioned with the audit, the question remains as to how reliable they are.

Thomas Igelmund is aware of such problems. As quality manager at the traditional Cologne-based company Bolder Arzneimittel, he is responsible for supplier qualification. As an expert for the development and production of pharmaceutical pastilles and on behalf of international pharmaceutical companies, he has been using the digital platform developed by Qualifyze for a year now. Igelmund is convinced of the advantages: "All processes related to our audits are clearly presented for me. I know exactly where we stand at every stage".

The positive effect on his work is great: "We often have time-critical activities, in the run-up to an approval, for example. If an audit is then not carried out within the regulatory timeline as agreed, problems arise," says Igelmund. Up to now, he had often entered the schedule of upcoming audits in the calendar himself and had to spend a lot of time making sure the deadlines were met. Such processes are perfectly suited to digitization. Today, Igelmund orders audits with one click. He can then be sure that it will be processed according to the schedule and that he will receive a complete report at the end. He can track the progress of the process at any time via the platform.

Nicole Richter, a Qualified Person at the pharmaceutical company Glenwood in Munich, also appreciates these convenient processes. "I send a list of the required audits to Qualifyze and shortly afterwards I have the corresponding offers," she says. This service is ideal for medium-sized companies in particular. "In Germany, we still manage most of the audits ourselves. But if the suppliers are located further away, the effort is too great for us," explains Richter.

Shared Audits
When auditors travel to suppliers, they check them in elaborate processes for certain quality standards and conformity with the guidelines of Good Manufacturing Practice (GMP). Until now, pharmaceutical companies have usually archived the findings on their own premises. There is no exchange with the audit results of other companies. Every audit is recreated, even if the supplier has just answered the exact same questions to another auditor. This makes the process very inefficient for the industry.

Qualifyze makes the audit results shareable with others. Transparent data exchange and constant communication between all actors in the supply chain avoids overlaps when auditing suppliers.

"Qualifyze makes the audit results
shareable with others."

Continuous exchange
Pharmaceutical companies are required by law to audit their suppliers every two to three years. A reliable, lasting statement on their quality is therefore hardly possible. Regularly, medication is recalled due to deviations from GMP guidelines.

Qualifyze wants to simplify and secure these audit processes for the pharmaceutical industry. For this purpose, Qualifyze offer a comprehensive service, which is adapted to the needs of each customer.

Qualifyze's platform provides a digital network that connects customers, suppliers, auditors, subcontractors and soon also authorities. Companies can use it to continuously exchange quality data about their suppliers. The process is transparent and above all secure - supported by digital technologies that are highly efficient. The platform also places qualified auditors who act on behalf of the customer. They are located in China and India, among other places, where a particularly large number of suppliers produce.

The platform maintains a global pool of independent and accredited auditors. They are qualified by the platform operator in a complex process. Those who pass it not only have high academic quality and long professional experience in the pharmaceutical industry. Qualifyze also checks the suitability of the candidates in practical tests.

Growing demand
However, auditors will also have to face regular reviews by customers and Qualifyze at a later date. This is the only way to guarantee the high quality of the audits to the clients. The demand for the service is great: After only eleven months on the market, the ISO 9001:2015 certified company recorded triple-digit audit requests in the first quarter of 2020. For about half of the orders, the auditors are active in Asia, the other half are from suppliers within Europe.

These audit reports were prepared for smaller pharmaceutical manufacturers as well as for global industry giants. For a fee, companies can also make their own audit results available on the platform for the benefit of all parties involved. This reduces costs for the individual companies while at the same time increasing the volume of audit data.

"The processes are automated
and thus guarantee consistently high quality".

Qualifyze founder David Schneider sums up the benefits for the industry: "We help pharmaceutical and other life sciences companies save time and money". The processes are automated and therefore guarantee consistently high quality. This gives companies an overview of which audit reports are already available, when the next shared audit is planned and how much it will cost. This clarity and simple tracking of all issued orders facilitates internal processes and at the same time increases security in a sensitive area.