Merck improves safety and compliance visibility with Appian BPM

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In heavily regulated industries where safety is paramount, and where inspections can - and do - happen at any time, visibility into an organisation's safety and compliance data is absolutely vital.

For US-based Merck & Co (MSD outside the United States) the new de facto standard for gaining visibility in its safety and regulatory department is to make the most of business process management tools and automation.

Practically everything in pharmaceuticals eventually touches labelling and packaging, and it is these seemingly simple elements that are essential to the eventual safety of the products, for instance, updating products with the latest medical information. This is an ongoing process because life science and medicine is always evolving, as are the compliance regulations around it.

As a result Merck has been embarking on a major digital initiative around end-to-end labelling. Even with the emergence of digital technologies, most of the data concerning compliance was siloed in emails and spreadsheets, and so, groups of people would have to spend a lot of manual labour time combing over the final details of each product.

In verticals like pharmaceuticals it's fair to anticipate that when there's not an inspection happening in one part of the world, it's likely that there is in another, and so Merck has to always be diligent and inspection-ready.

Therefore, visibility across the end-to-end business process is becoming increasingly important. As Merck is a multinational, the complexity here is multiplied, and additional diligence is required.

Business process management tools from the vendors like the low-code platform Appian provide Merck with the means to build a visibility snapshot, as well as maintain end-to-end transparency and control, so that managers are able to get a clear view of changes to labelling data across the entire product suite.

"If you look at how big we are, and how many countries we're in, we're going through regulatory inspection probably twice a week, not just in this space but generally speaking, if you're a large pharma company, you're always under inspection," explained Chris Lee, VP of global regulatory affairs operations and quality management at Merck, speaking during the Appian World conference earlier this month in San Diego.

"That inspection typically ties back to your label, whether it's a manufacturing inspection, whether it's an inspection for a clinical trial, or a 'pharmacovigilance' inspection - it all comes back to a product label."

Now, when there is a change to the labelling, this can be easily inputted into the workflow management tool - so instead of back-and-forth exchanges via email the company can pull up a dashboard that it created and see what stage each product or trial is at, along with any events that might be impacting those.

Brexit, for instance, is adding uncertainty into everyone's supply chains and it's no secret that companies in virtually every sector are building in risk management in the event of a possible no deal Brexit, including advertising and labelling.

Another aspect is traceability, something the company addressed with a 'bi-directional' capability, so that the use of Appian's tools is not only top-down from headquarters. A country team can input data to Appian, headquarters will be able to approve that change, and then it will go out again through Appian.

Although time saved was not the only (or even main) metric for signing up with Appian, which is proving popular in the pharmaceutical space, Lee estimates that the tools have helped increase the capacity of the business process by "roughly 10 percent". Cycle time was reduced anywhere "between 30 to 40 percent", as an estimate.

Next, the company will likely use Appian to tie its data points together, across manufacturing, compliance, and commercial, as well as in life sciences and R&D.

"You're going to see Appian take off across the enterprise because there are other pockets of the organisation that use it," he says. "That's what we have to work towards - all of us in pharma - and one thing that I see with Appian is if you look at the drug development continuum, there's a lot of different disciplines: you've got physicians, you've got nurses, you've got scientists, you've got lawyers, regulatory people involved in that process.

Lee is now eying his next Appian project at the R&D level. "How do we tie our end-to-end submission process, through drug development, and then quickly getting it into a process and a format where we can do our submissions a lot more efficiently and hopefully right first time?" he asked.

Appian is already laying down the foundations as an orchestrator of robotic process automation (RPA) bots - so that firms can understand what automation processes it is running and where, trace back those processes, and ultimately decide how efficient they are being.

This could prove complex for heavily regulated companies. When robotics or automation enters the workforce, there is a large question hanging over responsibility and culpability: how can a regulator be sure that a bot has received the proper training? And which human takes responsibility for that?

"This is almost like a person, but it's not," says Lee. "What's going to happen when you replace a person with a bot? I could imagine sitting in an inspection situation where the inspector would say: how do you know that bot is trained? What's that bot's training record? How do you prove that bot is trained to do what you have it doing?

"We're thinking about it now, because as we progress, we're definitely going to have to answer those questions - as we start putting out more and more bots that cover more heavily regulated parts of our business, we're definitely going to have to be able to answer that question before we do that.

"The thing that excites me about what we're doing, and what Appian is doing, is that ability to actually almost wrangle the bots," he said, adding that it will be a major opportunity for Appian to make a possibly unwieldy digital workforce into a simplified process and gain control over that.

"That's a leading position there," Lee said, "where you could use the Appian tool to actually wrangle those bots, and keep track of what's happening as an orchestrator."

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