Pharmacovigilance Audits - views from an auditor

Jackie Roberts shares her thoughts on GVP auditing.

I really enjoy doing pharmacovigilance audits. Over my career I have done quite a lot from full GVP systems audit to single product audits and audits of systems (such as the medical information system). Audits are so important and a key part of ensuring compliance. Making sure that the company’s systems and processes are regulatory compliant, effectively implemented and properly documented are key to patient safety. I enjoy the interaction which comes with auditing, putting people at their ease, helping with constructive feedback and preparing companies for regulatory inspections. Auditing isn’t for everyone, there is a lot of preparation before it, during it you have to cover a lot of areas sometimes asking difficult questions and after it you have to provide the audit report highlighting any deficiencies and areas for improvement.

As an auditor there are some things companies can do to make my life easier, these are:

·       Send documents in plenty of time, if I have requested to see certain SOPs it is good to get them to me as soon as possible, so I can review well before the audit

·       Answering the questions asked is always good! If you don’t know say you don’t and don’t try to make something up. I would much rather an honest answer that you don’t know or a procedure is missing or hasn’t been implemented yet, to a convoluted tale that takes time to unravel. If the question is not clear ask me to repeat it or explain what I’m looking for.

·       Making sure the people who do the work or know the answers are available is also very important, sometimes this isn’t the Director or leader of the department but the officers who have implemented the procedure.

·       When information is requested during the audit please try to provide it as soon as possible, the audit can’t be closed until all the required information is received from you

·       Don’t take any findings personally! Findings are neither a personal attack nor a reflection of how you do your job. From experience I know how busy people working in companies are, how many tasks you have to juggle so I am not expecting perfection. Hopefully I will be able to give you some assistance with examples of best practices or suggestions for doing things differently.

If PharmaGuard can help you with your GVP auditing requirements then please do contact us, both Lisa and I have auditing experience and would love to support you. Please contact us either via the website or by email at info@pharmaguard.co.uk