How to Prepare for a Pharmaceutical Regulatory Audits?

Quality. A common word used by everyone to signify that the activity performed is as per the defined standards. Pharmaceutical and life science are two industries that need to ensure quality to the core since deviations from quality can be life-threatening. Hence, to ensure the quality of pharma products, regulatory audits take place.

A regulatory audit of pharma industries is a process to examine and understand if the activities performed are as per the regulatory standards. Whether it is internal, external or surprise, with the help of Enterprise quality management software, you can digitalize and automate quality processes. It will significantly save your time & effort, providing highly efficient audit reports.

Below are a few key focus takeaways for preparing Pharma Regulatory Audits

Evaluate –
The first step will be to review all the previous documents to recollect previous audit observations and responses. Post that, review all your documents like Batch records, Standard operation Procedures, Change controls, Market Complaints and Deviations. Be assured that these are up to date as per the current status.

Circulate –
Each operating department will have at least one individual accountable for the audit. It is their responsibility to break down and distribute smaller audit tasks internally. Since this is a highly responsible activity, he should have enough knowledge of quality auditing, documentation, records, systems, and procedures.

Compose –
Every selected individual shall prepare a plan to respond to auditor queries. Planning is crucial and will highlight all the winning points and the challenges. So, keep the department with maximum winning points first.

Audit 0.0 –
As they say, “precaution is better than cure” we need to be prepared well in advance for all the queries and inconsistencies. On-time review and doing the first time right are the mantras to clear audits without observations. Doing this will surely help boost confidence for the whole team and double-check so that no loopholes appear.

Be Ready –
Lastly, audits can happen anytime, so ensure preparedness for these last-minute hassles. With such complex quality management, it would be advisable to have Enterprise quality management software that will help you automate all the processes, keep you prepared for audits and give you real-time insights on loopholes.

To start your digital transformation journey today, email us at sarjen@sarjen.com or visit qedge.sarjen.com and explore how quality management software can ease your auditing process for each individual. Edge out the quality management hassles with QEdge – A holistic enterprise quality management system.

Sarjen System is serving the Pharma & Life Science industry for the last 25 years. With an experience in the industry & knowledge, we keep updating our products regularly so that they are regulatory compliant at any given point. All our products are greenfield products and technologically updated as per requirements. Explore QEdge – your 360-degree quality management software to edge the hassles and be ready for audits anytime.