Putting the IT into ‘audit’

The global pharmaceutical industry is often held up as an example of a sector that exists on the cutting edge of what is possible. But that doesn’t mean that it can avoid its own tech disruption.

Digitalisation - the process of moving to digital business processes and away from legacy and paper-based ones -  is changing the pharmaceutical industry just as it is changing many others. One seemingly simple, yet business-critical change will be in how companies collect, share and analyse data, with the result that digitalisation will have a radical effect on how products and processes are audited.

When a consumer buys aspirin, paracetamol or any of the thousands of over-the-counter medicines, they are unlikely to give a second thought as to how they got there. Yet behind every purchase is a staggeringly complex manufacturing and supply chain. Companies must simultaneously balance rapid product delivery with stringent checks, maintaining impeccable health and safety standards and ensuring corporate accountability on a profit and reputational level.

It doesn’t grab the headlines in the way medical breakthroughs do, but how technology has improved operations is equally as important to the pharmaceutical industry as the people in white lab coats.

Digitalisation is driving improvements across the board

Digitisation is helping pharmaceutical companies adapt to the dual challenges of global supply chain complexity, and the ever-present pressures to keep prices and costs low. Better technology is helping to make companies more agile, which is improving the efficiency of internal processes and decision making.

At the same time, automation of low-level tasks via better-integrated software and hardware is delivering a step-change in the efficiency, speed, quality and responsiveness of many business processes.

By investing in these future-proofing technologies and systems, these companies are significantly increasing the visibility of how different processes work together. As a result, planning accuracy, manufacturing efficiency and productivity, inventory levels and service quality can all be improved.

However, in an industry where success is based on being able to have absolute levels of product quality, simply improving visibility and the speed of delivery and decision-making is not enough. This is why technological improvements around quality control and audit trails will make a marked difference.

The historical challenge

Historically, many companies operated with cumbersome, inefficient production facilities not fit for purpose in today’s environment of dynamic shifts in supply and demand. As more complexity has been introduced to manufacturing and supply chains, so to the complexity of internal processes has increased. The shift to on-demand and just-in-time supply means stopping, cleaning and restarting machines every time a new product or batch needed to be run to ensure there is no trace of ‘Batch A’ when the production of ‘Batch B’ begins.

Any contamination, missed procedures or inaccurate data risks a delay or even worse, a batch recall. And every step of every process needs checking and approving. And, regardless of all the innovation surrounding the pharma industry, when it comes to these kinds of work processes, the vast majority are still being done by a supervisor armed with a pen, a paper checklist and a clipboard.

Aside from being timely, expensive and grossly inefficient, this also raises the issues of trust and consistency. How can we be certain that every single check is uniform irrespective of form factor, batch, country or which supervisor was on duty at the time? Perhaps more pertinently, how can we be sure that every specific detail is tracked, measured and recorded accurately? The simple answer is that we can’t.

Improving the audit trail

Thankfully, technology today means it is possible to create a valid and provable audit trail that is repeatable and completely product and production agnostic. Checklists can be shifted onto mobile devices, with tablets available that meet even the most stringent requirements for use in Intrinsically Safe (IS) environments. Wearable devices allow workers hands-free capabilities, with voice controls and video capture. Whatever the device or process, data can be captured and shared in real-time, recording detailed metadata as part of the audit.

Not only is the data more granular, but digitalised processes can be infinitely customised and adapted. Need to document a check with a photo or video of a setting or reading? No problem. Tasks that require oversight or sign-off can now be handled digitally. All of this information is tracked, logged and stored so it automatically creates a historical bank of information.

This helps with everything from consistency to transparency of information. While the benefit of an audit trail is clear, it also improves quality control as any faults or defects can be spotted and acted on much quicker. It also reduces turn-around time and cuts cost.  

Most of these examples are centred around improving efficiencies in the processes themselves, and these savings can be considerable. We have seen examples where even savings of a few minutes per person per day can quickly scale across an enterprise to become multiple millions of dollars against the bottom line. But where many companies find the most value is when it comes to tracing and auditing these processes, and using that insight to make major improvements

For example, if an auditor wanted to know how long it took a worker to clean the machinery on batch No.9538, the company now has access to that data at the click of a button rather than spending hours checking and collating paper records. Ditto if they want to know how that process in that facility compares to five others around the world, or how July compares to June. What we now have is a complete and transparent picture of how business critical processes are being executed, which is transformative.

The last decade has seen much of the pharmaceutical industry shift from push manufacturing to leaner, just in time manufacturing in response to consumer demand. The next decade will see more automation, more insight and intelligence, and many smaller gains, rather than major upheavals.

But all of this depends on people working to capture all of this data. Without that basic, fundamental human step, the value and insight it can deliver are lost before you can even begin. This is the real impact of digitalisation.