What quality means to us at Qualifyze

The best support possible to the auditor and the best possible service to our clients, every single time you request an audit with us.

External Quality Management

The best support possible to the auditor and the best possible service to our clients, every single time you request an audit with us.

Our promise

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.

Our quality team

Within Qualifyze, we have a dedicated quality team to oversee the preparation, auditing and reporting process for your audit report. Each member of our team has been carefully selected for their knowledge and background within the industry.

We 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 we provide the best support possible to the auditor and the best possible service to our clients, every single time you request an audit with us

Our audit lifecycle
How does it work?

You request an audit through our Qualifyze Platform.
We review the request and redact a contract for you.
Our audit booking team will ask the auditee for a date for the audit. This date will depend on the urgency of your audit, our forecast of our auditors’ availability, and the auditee’s availability. We always try to adapt the audit length to the audit dimension (complexity of the process, the extension of the site, number of products to be audited, etc.). Once the audit date is scheduled, the auditor will be allocated by our operations team.

Each member of our quality team, according to their areas of expertise, collaborates very closely with our qualified auditors during the audit lifecycle.

For each audit, we seek information from the auditees and customers, verify the data received, and make sure to provide it with the utmost transparency to the auditor.

After adapting the agenda based on the scope of the audit and your requirements, we send it to the auditor to certify that it’s correct and then share it with the auditee so that they can make the corresponding plans on their site.

We receive the auditor’s report and conduct a thorough review to ensure consistency, confidentiality, completeness and to ensure the scope and customer requests are included in the report. The communication with the auditor is always open so we can collaborate on the review of the report and the delivery of an excellent product. Additionally, we make sure impartiality is always guaranteed, ensuring there is no conflict of interest identified between all involved parties.

Internal Quality Management

One of the most critical, important processes is, without a doubt, the selection and qualification of our auditors.

List of requirements

They are our eyes and ears during the audit execution, and we need to make sure that they have sufficient knowledge and experience for a reliable audit execution.

There is a list of requirements that needs to be satisfied in order to consider a candidate suitable for the auditor qualification process:

  • Educational background in life science or justified long experience in the industry
  • Strong experience in the pharmaceutical industry
  • Experience in performing audits with consistent records in the last 3 years
  • Evidence of relevant and accredited auditor training or justified experience in auditing with experienced inspectors
  • Good level of English

Auditor qualification process

Our 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 we have so far qualified more than 120 auditors in more than 45 different countries worldwide.

This international, highly qualified network allows us 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 we 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.

The quality of our reports

As an audit service provider, we strive to deliver a timely, understandable, comprehensive, and transparent report. 

The main objective of our quality team is to ensure that the audit performed by our auditors is perfectly captured in the report.

You 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.

Exceptionally used to point out the outstanding points, where matureness has been witnessed beyond the basic requirements.
Linked to sections where no important deficiencies have been found and there is no evidence of risk being introduced. We expect most categories to fall into this rating for compliant suppliers.
Used for items with important deficiencies where mitigation measures lead to risk being sufficiently controlled (i.e., there is no immediate risk to safety, but improvement actions must be implemented). This rating should also be used when limited information is available to evidence good compliance.
Used for items that are clearly introducing an unacceptable risk for patients. Critical observations or important major ones should be linked with “Poor” ratings.

What is our QMS system? (ISO)

We 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 we can provide a top level service we have implemented a QMS based on ISO 9001 requirements. This allows us to constantly improve our overall performance, meet your expectations and enhance your 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.

How do we maintain it?

We make sure that we maintain our QMS in a good state of compliance. At least one internal audit is performed annually and we have a system to manage different type of events (complaints, audit observations, internal non-conformities…).

Opportunities for improvement are always welcomed. Additionally, surveillance audits are done by Tüv Süd annually.

We want to highlight that Scilife is a key partner in maintaining our QMS. This eQMS has helped us to digitalize the documentation management system, our internal trainings, and the events and CAPA management.

How can you qualify us?

As a subcontractor of your company, we know it’s important for you to be able to qualify and validate our services.

This is why we have prepared a thorough qualification package which includes all the information related to our QMS and key processes. It can help or substitute any questionnaire you have in your systems for supplier qualification.

In any case, we are always happy to complete your questionnaires and welcome you in an audit if it is a requirement of your processes.