Being prepared for an audit is part and parcel of being part of the Pharmaceutical industry. In the last 5 years, the demands have increased existentially on both Pharmaceutical companies but also vendors, particularly as the demands for outsourcing continue to grow. Moreover, subcontracting is now an understood necessity in the areas of many business-critical activities such as local Regulatory Affairs and local Pharmacovigilance.
For some companies, managing audits can be a major challenge as it requires a lot of organization, preparation, managing expectations and the different personalities of key people that may be involved in the audit.
Some employees can literally fear an Audit as they can feel pressure and there is a generally a need to get things prepared quickly which can add to this concern.
At Arriello, we have a unique position of being a company that is both regularly audited and regularly conducts audits. The audits that we conduct ourselves take several different forms. They can be on behalf of our clients, typically in these 5 key areas:
The most important things are to stay organized and think ahead of the situation. Your audit does not have to be stressful. Here are a few steps to help you keep it manageable:
From my previous experience, the auditor will ask you to provide suitable dates for your firm to conduct the audit. Below are some great points to consider:
Once you have received the audit agenda, you will clearly know what areas and systems will be inspected.
Double check with the auditor about any specific interview requirements in advance.
You might have:
Therefore, it is necessary to:
Make sure the room has got a reasonable size and access to the internet. Give the auditor the space they need.
Remember, the day of the audit is not the time to start collecting the documents on the list. The longer it takes you to get the auditors what they need, the longer they must stay—incurring more hours on your organization’s budget. Follow these 5 Steps above and you will start to be on your way to making the audit run as smoothly as possible.
If you or your company feel that you could benefit from our support in preparing you for an audit, then this is something that we have a lot of experience in and would be happy to assist with. Simply contact me or your Account Manager and we can discuss a plan that suits your individual needs.
For more information and a summary of the different types of Audit Inspection Readiness support that we can provide, please look at our website here
Lead ISO Auditor/ Pharmacovigilance Auditor