Qualifyze: Consistable and Reliable Audits

David Schneider

Founder & CEO

“We want every detail to be easily understandable, that’s why we’ve introduced a “Traffic Light” rating for each of the audited items in order to draw attention to those items introducing risks to patients”

Qualifyze is building the trust layer for global supply chains. The one that turns compliance into meaningful value, with human relationships at its core. The company provide auditing services by thinking globally, while acting locally, using curated data and actionable insights to help stakeholders make the most of their audits. Consistent, reliable and flexible audits, at scale. That’s the company’s DNA. The same DNA that makes everything else the team do possible. “At Qualifyze, we’re committed to providing you with excellent third-party audit services.Our promise is to provide our partners transparent and thorough audit reports, while keeping their workload to a minimum. We do this by organizing, managing and renewing supplier audits in the pharmaceutical industry in an efficient and effective way, and removing the audit burden entirely.”

Within Qualifyze, the company have a dedicated quality team to oversee the preparation, auditing and reporting process for audit report. Each member of its team has been carefully selected for their knowledge and background within the industry. The company have specialists who are not only knowledgeable in all areas of the pharmaceutical industry, but also have years of experience working in each specific area of the industry. Having been part of different areas within the industry, each has received or conducted audits in both the private and public sectors and has a thorough understanding of the most important elements of each project.Each audit is carefully evaluated and assigned to a member of the Quality Team according to their background, ensuring that provide the best support possible to the auditor and the best possible service to our clients, every single time they request an audit.

The company’s auditor qualification process is meticulous and aligned with the industry and the ISO 17020 requirements, following the steps: Questionnaire (SAQ), Interview, Reporting reference, Auditor classification, Winessed audit (when applicable), Final Report.According to the above criteria and process, the company have so far qualified more than 120 auditors in more than 45 different countries worldwide.This international, highly qualified network allows the team to use the best auditor for each audit. Speaking the language and knowing the culture is key for a smooth audit process and appreciated by all parties. It is also important, with such a big pool of auditors, to make sure that the team are always up to date with all current regulatory requirements. This also goes for all our internal processes as well. “This is why we have implemented an ongoing supervision process to make sure that we maintain high standards and a common voice. The executive team meets regularly to identify any “negative trends” and implement any necessary precautions or actions.”

As an audit service provider, Qualifyze strive to deliver a timely, understandable, comprehensive, and transparent report. The main objective of its quality team is to ensure that the audit performed by its auditors is perfectly captured in the report. The company will be able to easily detect in an orderly, agile, and user-friendly manner the sections of interest within the document, as well as being able to have a quick assessment of the provider at the beginning of the document. “We want every detail to be easily understandable, that’s why we’ve introduced a “Traffic Light” rating for each of the audited items in order to draw attention to those items introducing risks to patients.Each section assessed within the report can be easily categorised into 4 different ratings: Poor, Acceptable, Good and Excellent.This ensures that you can quickly and reliably obtain information about the supplier, and allows you to easily compare the same section in each follow-up audit report and also between comparable suppliers.”

The company’s team understand how important it is to have an implemented Quality Management System (QMS) supporting our services within the highly regulated sector within which we operate. To make sure Qualifyze can provide a top-level service have implemented a QMS based on ISO 9001 requirements. This allows to constantly improve the overall performance, meet expectations and enhance satisfaction. “Risk-based thinking part of our DNA. Our QMS has been formally certified by TüV Süd who has granted us a valid certificate that will be re-certified by the end of 2022.”