So, what exactly do we do? How many times have I been asked that? Whether it’s small talk at a wedding, or someone I’ve bumped into at a conference, the puzzle is always how much (or how little) to say – I want to tell you what we do, but I don’t want to bore the pants off you…
The simple answer is that we do lots of things – but everything we do is related, one way or another, to pharmaceutical quality systems, and is driven by protecting patient safety. And we are very very good at it.
Two of our areas of expertise are validation and auditing. Validation (proving that the system works reliably and reproducibly) stems directly from the quality system. And in any audit you will be asked, ‘Is it validated?’
We can qualify your equipment and systems, new build or refurbishment, we can validate your computer, your cleaning, your analytical methods, and your processes. We can carry out gap assessments so that you know how to get from where you are to where you need to be. We can help with remediation plans. We can design risk-based solutions to your validation problems so that your validation work is carried out efficiently. We can help you to remain compliant. And we can qualify the equipment and validate the software you need in order to fulfil your serialisation commitments.
Generally auditing refers to scrutiny of financial matters, but in the pharma industry it means checking records to ensure that they are compliant with the regulations and guidance governing the particular process that is being carried out. I tried really hard to make that sound sexy. Having the auditors come to visit can be a very stressful time, but we can help – staff training and mock audits take some of the mystery out of it and allow you to spot the problems and put them right before the inspector even arrives. See our blog on ‘How to Keep Your Auditor Sweet’. We also do inspection management and inspection response. We can carry out vendor audits on your behalf. And we can train your staff to conduct internal audits and supplier audits.
And in all of this, Quality systems are central – we can assist with change management, deviation management, self-inspection, data integrity, performance quality reviews and quality KPIs.
So, where do you want us to start? We’re here to help.