Our Expert Tips on Preserving Relationships with Auditees

By The Zigzag Associates Global Team

Maintaining positive partnerships with Pharmaceutical and Biotech vendors and clinical sites are of utmost importance in the drug development cycle. These auditees are incredibly important to the regulatory approval and ultimately, commercial success of life changing therapies.

With our team of expert auditors, we have compiled the best tips on ensuring that during an audit, those positive relationships are maintained even in the process of delivering news that perhaps, auditee practices are subject to receiving findings.

Selecting the right third-party audit partner plays a crucial role in this process. A skilled audit partner provides an objective, thorough evaluation of your vendors, identifying potential risks and areas for improvement. By choosing a reputable and experienced audit partner, you ensure that your vendors are not only meeting the regulatory requirements but are also aligned with your quality standards and business goals. This alignment is key to fostering trust, transparency, and long-term collaboration.

Here’s what our experts say:

Teresa Barros, CCRP Senior GCP Quality Assurance Manager

“One thing I learned and the auditors I remembered the most were those that delivered the “not so great” observations in a compassionate manner; this is something that I have carried on in my own professional auditor role.  Auditees are very proud of their role in research and to be told what they do doesn’t adhere to best practices can put them on the defense quickly.  I put myself in their shoes, I try to find a way to inform them in the manner that I would want to be informed and it has worked out very well for me.”

Cheryl Rediza, Project Manager

“Keep the communication up with the auditor, reminding them of the deadlines and who the key stakeholders are for the audit, liaising with the auditor to make sure they have everything they need prior to the audit - documents, accesses to the relevant electronic systems, a pre-audit meeting in the diary (if needed), and letting them know they can turn to the PM in case of any issues. Ensuring that you are "on hand" in a timely manner for issues if they arise.”

Jasmine John, QA Manager

Usually during audits especially if there is a critical or major finding I like to tell the auditee:

“Please keep in mind this audit only represents a sampling of time and that the highlighted findings discussed during this meeting have not yet been classified because an internal review will be conducted during the finalization of the audit report within my team and with the Sponsor to finalize the finding classifications. Additionally, please keep in mind that these process gaps/deficiencies identified are gaps in the various processes I reviewed and are not a personal representation or personal attack on anyone. I greatly appreciate the work that is done by the site staff to conduct the various trials ad hope these observations will help with process improvement in the future.” 

Emphasizing that the findings are meant to identify process gaps and deficiencies and aren’t a direct reflection of anyone’s work usually helps prevent auditee frustration or combativeness especially if the findings are major or critical in nature. I’ve found this also helps to keep the point of the audit in perspective for the auditee so they will see the audit as a positive, educational event rather than a negative experience.

Cleopatra Dimopoulos, Project & QA Manager:

Establish documented best practices in giving positive feedback, while educating on areas that need improvement. Using direct communication and discussing issues is far better than an email.

Providing feedback in a timely manner assists in continuing a positive relationship.

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About Zigzag Associates:

Zigzag is a United Kingdom headquartered consulting firm, with global office locations, specializing in pharmaceutical research quality and compliance. With a team of experienced professionals and deep industry expertise, we provide comprehensive consulting services to pharmaceutical companies, helping them navigate regulatory requirements, optimize quality systems, and ensure compliance throughout the drug development process.

For more information, please contact us here: https://www.zigzagassociates.com/contact-us