Staying Compliant and Increasing Speed-to-Market with Adlib

In the life sciences industry, it's essential for companies to be compliant with industry regulations, but at the same time, speed to market is everything. Getting products and services to customers as fast as possible is critical, but companies also have to be highly diligent about quality throughout the process. One mistake can set you back from a competitive standpoint and also frustrate customers.

But regulatory compliance is serious business. I used to joke that the quality department was often like a team of beat cops, telling people when it was safe to cross the street. Traditionally, the quality department has been in that less-than-fun position of making every stage in the process compliant.

But if you could use software to automate those processes, your quality department doesn't have to be the bad guy. At MasterControl, we want our customers’ compliance teams to be seen as the good guys—because that’s truly what they are.

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Doubling Down on Quality

MasterControl produces quality management software (QMS) used by companies within regulated industries. Regulatory bodies, such as the FDA (U.S. Food and Drug Administration), commonly announce requirements for new and updated industry standards, such as how to manage documents, training timelines, production records in your manufacturing plant, and other requirements that companies need to follow to remain compliant.

MasterControl designed an electronic system that allows our customers to do all that faster and with greater precision, while replacing much of the paper processes that the industry has been consuming for years. We’ve built a secure system that ensures documents and data are managed and controlled in a compliant fashion. Integration of document control with our training module makes sure the users get their training tasks and can easily sign off when tasks are completed.

The transition from paper to electronic systems needs to be seamless, and must speed up your processes rather than slow them down. We’ve been doing exactly that for our customers for more than 20 years, and as the industry has changed, we’ve evolved in the era of digital transformation, moving many of our processes to the cloud and updating our offerings.

MasterControl initially focused on pure document management and evolved into training. We then moved into business process automation, which allows our customers to build and fill different types of forms based on their unique needs and their industry. We're trying to empower the regulated life sciences organizations to leave behind the inefficient paper based systems.

I started my career many years ago as a pharmacist, attended graduate school and then started working in pharmaceutical research. I have family members who rely on medicine to improve the quality—and longevity—of their lives, so it’s an emotional process that has always been enjoyable for me to be a part of.

We recently held our annual fall customer summit and heard firsthand from one of the keynote speakers how a company that uses MasterControl created cochlear implants  (a medical device) that helped her son and parents to hear. This device company was able to get new versions of the cochlear implant out to patients sooner because they had MasterControl in place. It can get very emotional when you hear how our customers’ products are changing the lives of real people and their families. This is what motivates technology workers in high demand to join MasterControl and many, like me, to stay for more than a decade with the company.

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Setting Standards and Finessing Formatting

More than 20 years ago, the FDA started pushing for PDFs as the standard acceptable document format to use in compliance-related documentation. The FDA, among many other regulatory bodies, has set standards for document formatting that must be met or a product submission will be rejected. Time is often of the essence in order to meet regulatory body submission deadlines.

Yet, even today, with all the technology now available, most people still don’t know how to edit or convert to and from PDFs. And even if some know the basics, they have complex, high-volume needs, and can’t afford to do it themselves or risk making a mistake.

MasterControl needed to provide that functionality to our customers, and so we tried to create it ourselves. But as our customer base grew, our in-house PDF publishing engine couldn’t keep up with the demand and the increasingly variety of file types, operating systems, and word processing software our customers were using.

Our engineers spent an inordinate amount of time trying to make this work. A few years before I joined MasterControl, my predecessors discovered Adlib Software. We’ve had a longstanding partnership ever since and they've become as much a part of MasterControl as our documents module.

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Formats, Fonts, File Types, and Beyond

MasterControl receives documents from our customers in the original unstructured format or file types that need to be converted to PDF. We have all sorts of functionality around creating custom headers, footers, expiration dates, cover sheets with metadata, signature manifests, watermarks with the right layout, colors, and verbiage within them, and so much more.

We can put watermarks anywhere on a document. We can layer them over and under images per the customer’s needs. Adlib gives us the flexibility to make more than just a bare PDF—Adlib gives us the ability to create a document that meets the customer's needs, exactly the way they want it. And when it’s time to download their PDF, they don't have to worry that they're downloading previous or out-of-date versions, because the documents module ensures the document is current and the system gives them a PDF that can't be modified.

This locked-in PDF is critical to the customers document management processes. Every customer wants those PDF documents. They don't want to have the native documents floating around because someone could alter that document. If someone make an unauthorized change to the specification for a cochlear implant, for example, it could be built wrong. In an industry like ours, there’s no room for mistakes.

We started off with a few dozen file formats. And it wasn't long after that, the "e-world" expanded to hundreds of file formats and our need for a very robust PDF conversion engine. Adlib allows our customers to enjoy the PDF conversion and customization that they need for their business. They’ve come to rely on us for that and we rely on Adlib. We haven't yet seen a file format that Adlib can't handle.

Right now, 98–99% of our customers use the PDF publishing engine from Adlib as part of their MasterControl process. It helps us to convert tens of thousands of documents every day. PDF renditions of internal MasterControl documents have become crucial to our company's processes as well. Our customers and prospects audit us several times a week, so we can give them a special hyperlink that shows them our documentation and how our procedures are helping them remain compliant.

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An Extension of Our Team

We look at Adlib’s development team as an extension of MasterControl. We’re all on a first-name basis with the Adlib partner team. We invite them to our customer summit, and we visit them at their headquarters in Toronto several times a year. We've just had so much history with them. We discuss changes in their product as well as changes in our product, and how those might impact one another. It's always fascinating and kind of fun.

This level of team integration is good for our customers too. Adlib is so integral to the services we provide. By having a deeper connection to Adlib, our customers know our offering will only get better.

Adlib is part of our fabric. It's the light switch. It's the hot water in the shower. It's that thing that customers rely on without thinking about it—it just works quickly and reliably. Adlib gives us the ability to look at other things we could do to say, "How can we use Adlib in a new way that will help our customers?"

The speed and reliability of Adlib's PDF output have become so fast and so automatic for our customers that even when they have a big import to compile and convert, they’ll still sit at the computer and just wait for the PDFs to come through so they can send those copies to their partners/customers.

If our customers suddenly lost access to our service or to Adlib, the impact on them, their teams, and their processes would be huge. They wouldn’t be able to move their manufacturing processes forward, or get approvals to build their products without it, especially as they’re on tight timelines. Without those documents, people’s and possibly patient's lives would be negatively impacted. The business impact would be significant as untold amounts of raw product might be wasted as a result. The cost of our products and services are invaluable because they’re business-critical.

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Changing Lives Through Process Innovation

One of the things that we're looking at now is new ways to use Adlib to help customers. We're talking to customers at our summits, and our trips to visit our customers. The product group travels at least a couple times a quarter to visit customers. We'll say, "Tell us your pains. What’s not working and what would you like more of? What do you think about this idea? What do you think about converting your third-party scanned documents to searchable text? What else would be useful?"

We're continually looking at how can we add new features for our customers even faster that'll make their lives better and their business processes work faster, so they can get their products to their customers faster. We want to help them do it.

At the 2019 Master's Summit, that firsthand story of how our customers' cochlear implants impacted a family was very moving. I don't think there was a dry eye in the place. The human impact of what we do isn’t lost on us. We know that speed, accuracy, and quality can save lives.

We’re proud to be able to support our customers’ missions with Adlib. It’s one of our company’s core values to get life-changing products into the hands of more patients faster. We want to help our customers do that every day. That’s worth getting up in the morning for.

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Lane Hirning

Product Management Director at MasterControl

Lane Hirning has been with MasterControl in the Product Management group since 2006. The PM group is responsible for new product design, functional requirements, implementation oversight and creation of marketing material. Prior to joining MasterControl, he served in various positions in a pharmaceutical company, including research scientist and director of the IT group. All of those roles had one thing in common, the development and management of software applications for the pharmaceutical industry. These included applications such as custom chemistry databases for research scientists, regulatory document management, and submission management systems. Hirning has degrees in pharmacy and pharmacology as well as specialized training in databases and computer software applications. He currently works with SAFe development teams on MasterControl’s software platform, system security and with migration of sections of the application into cloud services.

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