18 June, 2025
Ready for Audits (Management)
KEY POINTS TO A SUCCESSFUL AUDIT IN DRUG DEVELOPMENT
Why are we being audited?
Quality management at Creatio is fundamental to guarantee the reliability and traceability of the results and activities carried out. In our laboratories, where we work with innovative and complex processes, implementation of a robust quality management system is essential to fulfill with regulatory standards and ensure that each stage of the research and development process is done in optimally.
Our quality management system allows us to identify and correct potential they affect mistakes before affecting the finals results. In addition, quality management fosters a culture of continue improvement, where constantly seek to optimize processes and procedures to achieve higher levels of excellence.
However, a declaration of intent alone is not enough, it is imperative to demonstrate compliance with established regulations to regulatory and certifying authorities. Therefore, we undergo audits that asses regulatory and policy compliance. It is essential that these audits are carried out satisfactorily.
Bellow, we presented a list of advice to ensure an audit develops optimally.
What should we consider before the audit?
Preparing for the audit in advance will help you be better prepared in front of the unforeseen events that could put you in an awkward situation. It is important to consider the following points:
Provide a presentation for the auditors: if this is the first time conducting an audit, or the auditors are unfamiliar with the entity, providing a brief overview will help them get their bearings. If the presentation is conducted by management, auditors will positively value their involvement during the audit.
Communicate the audit plan to all staff: informing the agenda to the team, will help them to know with aspects will be audited and who will be necessary to be accessible to ensure a smooth audit.
Find appropriate audit rooms that meet the audit team’s needs: a good working environment will make the audit less burdensome. It is important to have in consideration whether access to digital documents is necessary, whether there’s sufficient space to submit and review documentation, and even a designated space for auditors to meet and discuss more privately.
Maintain an orderly workspace: it is important that during the audit shows that your workspace reflects professionalism, order and control. This will save you all the things have their place, and this must be easy access and easy to find. It will save you a lot of time searching for all the requested documentation.
How do we face the audit?
It is understandable that you might feel nervous before an audit, as you want everything to go as smoothly as possible. To avoid any setbacks, we give some tips:
Remember that no one is better than the staff in your own department to explain how they work on a day to day. Feel part of the system and confident that you can do it very well.
When the auditor asks you a question, provide only the information requested and show specific documentation. It is not necessary to go through related topics, unless needed.
To feel secure, it is highly advisable to have documentation easily accessible and localizable. In case you can’t find a document when the auditor requests, don’t worry. You can simply suggest them to continue with the next topic and ask for a sometime to find it or ask the reference member who can help you find it. Therefore, it is essential for the staff working in the area to know how to find the relevant laboratory information (PNTs, data logs, calibrations, maintenance, etc)
If an error is detected, it is important to be willing to resolve it.
You may occasionally disagree with the audit team’s findings. When these are mentioned during the audit, or at the end, you can express your opinion, always showing the supporting documentation. It is crucial to clarify all the doubts, both with the audit team and with the Quality Assurance staff.
Do not forget to discuss the audit results with your colleagues. Remember that teamwork is fundamental for advancing with Quality.
Conclusion
Audits should not be viewed as obstacles, but as essential checkpoints in the continuous improvement of biomedical research and drug development processes. With thorough preparation, clear communication, and a strong quality culture, audits become opportunities to reinforce excellence and ensure compliance with confidence.
This article was written by Mª José García and Felipe Chiappe from the Quality Assurance Department at Creatio.
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