Why Audits Are Crucial in Today’s Biopharma Industry

May 19, 2022

The single word "Audit" brings many thoughts and emotions into the minds of all who are reading (and writing) this text. Unfortunately, many of those thoughts and emotions are not unjustified due to various poor experiences many of us have had as the sponsor of audits, the auditee, or even as the auditor. Throughout a diverse field of industries, audits are accepted as a necessary process to ensure quality, which, most certainly, includes our GxP (GCP, GLP, GMP) environment. However, this necessity does not demand that we continue to address auditing with the same mediocrity and painful points many of us have come to expect, or even dread, from the process.

With the perspective of an increasingly post-pandemic environment*, the idea of a return to routine, more on-site, auditing is becoming reality. After months and years of no on-site audits at many facilities, what truly awaits the auditor upon the first steps into a site is anybody’s guess. The attempts of companies to conduct ‘robust’ remote audits during the pandemic have almost certainly left stones unturned and rugs not lifted at many vendors and sites. This is not to paint a picture of lawless houses of horrors, but just a sober realization that many companies have faced impactful pandemic-related challenges and that many of their facilities have gone unvisited by auditors for some time. Of course, on-site audits are not warranted for all types of vendors, but a post-pandemic array of surprises may now await where this hands-on assessment is important.

In a return to some semblance of a pre-pandemic audit schedule, you should ask yourself whether a robotic pivot to your previous ways of audit planning and sourcing make sense or if, like many things after the last two years, now is the time for lasting change. The latter path opens many opportunities to maximize value in the audit sourcing experience and delivery. Expert assistance in the development and execution of your quality audit schedule provides significant benefits to increase your bandwidth and strengthen your compliance stance. Linical provides such opportunities for change in your process through the following offerings:
  • Strategic audit planning support
  • Targeted audit scoping based upon risk
  • GxP (GCP, GLP, GMP) audit coordination
  • Auditor resourcing and flexibility
  • Ease of process
  • Cost transparency and value
As many things have changed globally due to the pandemic, perhaps your approach to auditing should change – for the better. This change should be an enhanced experience in strategically scoping audits, resourcing auditors, and in the overall management of the process. Let Linical partner with you in your return to a full auditing schedule to ensure a painless experience and an increased ability to focus these efforts into truly value-based, risk-mitigating opportunities.


* References to post-pandemic environment are used and intended to describe the current period (H1 2022) of significant reopening in many areas around the globe. It is recognized and appreciated that COVID rate unpredictability continues to present changing access and opening realities globally.

Author:

Tyler Cochran
Vice President, Compliance and Regulatory Affairs - Linical Americas