It can be difficult to know where to start with digital manufacturing. This is particularly true in highly regulated industries like pharmaceuticals, biotech, and medical devices, where cGMP requirements add a layer of complexity to the process. 

Still, there are a few, proven steps you can take to implement digital technologies in regulated environments. Following these steps will ensure that your projects are successful. 

The Big Takeaway: Think in Terms of Solutions, not Technologies.

Digital transformation is often positioned as a technological problem. 

This makes sense. Many of the most exciting developments of the Fourth Industrial Revolution are the result of a convergence of new technologies. 

But it can be a mistake to put technology first. This is because new technologies, 1.) Aren’t guaranteed to solve the problem, 2.) Can require significant digital infrastructure to work properly, 3.) Aren’t helpful unless they’re creating value. 

Instead, manufacturers should identify a simple business case that’s guaranteed to produce results.

In our experience, manual or paper-based processes that can be digitized easily are good candidates. Industry 4.0 technologies excel at improving visibility, efficiency, connectivity, and data collection, among others. Identifying places where a specific technology can improve one of these criteria is where you should start. 

So rather than asking, “What’s our IIoT strategy?” it’s more productive to ask, “which process would we like more visibility into, and is there a way IIoT can achieve this?” 

So whether you’re looking for electronic logbooks, guided line clearance applications, or in line quality assurance, the soundest digital strategies depart from a use-case. 

5 Tips for Digital Success in Highly Regulated Industries

We’ve helped many manufacturers successfully deploy digital technologies in regulated environments. Here are observations for making digital projects successful.

1.) Don’t Let Fear of Risk Stifle Innovation

When we speak with manufacturers in highly regulated industries about digital transformation, the number one concern we hear is always the same: compliance. 

Naturally, manufacturers want to know whether or not new technologies can operate in a cGMP compliant facility, and whether or not a small product feature has the potential to create major headaches down the road. 

While this mentality is fair, it can lead manufacturers to miss transformative solutions at the consideration stage. 

There are many ways to use digital technologies in FDA compliant facilities.

2.) Think in terms of small problems. 

Many manufacturers are used to thinking in terms of multi-year, multi-million dollar improvements. This is especially true in highly regulated industries, where the costs of QMS, LIMS, and other enterprise software solutions can easily top seven figures.

Nevertheless, this mentality can make it easy to miss low-hanging fruit. 

For example, one pharmaceutical manufacturer we work with created an order of magnitude gain in productivity just by digitizing their SOPs. 

Using paper-based SOPs, disassembling and cleaning a complex piece of continuous manufacturing equipment took up to two weeks. With digital work instructions, the manufacturer cut the process down to two days. Further, the digital work instructions reduced errors, simplified compliance documentation, and collected data that the manufacturer now uses for process improvements. 

This manufacturer thought in terms of simple solutions, and realized massive results.

3.) Use small projects to build a digital infrastructure 

The manufacturer who used digital SOPs didn’t just create a single-use solution. 

Rather, they built the foundations for a broader digital infrastructure that can support further initiatives. 

The work instructions were supported by cloud storage and computing. They connected to IIoT devices, which ensured that workers performed all of the steps correctly in line. And it created the foundations for digital documentation that provides an accurate, real-time record of production. 

This, in turn, decreased the time spent pulling data from disparate sources when preparing for a batch record review, and created a record of process validations that could be used to demonstrate compliance.

The point to emphasize here is that this manufacturer didn’t pick an IIoT or cloud solution to check a box. 

They picked a pressing business case and used it to inform their digital strategy. 

4.) Don’t try to replace your ERP, QMS, or LIMS

While new technologies offer more flexibility than traditional systems, there’s no reason to think of them as mutually exclusive. 

Manufacturers can use digital technologies to power localized, targeted improvements in parallel with existing systems. 

Many of the most impactful improvement come when digital tools are used to augment and extend systems of record. By adding new data and functionality, targeted digital solutions work with existing systems to improve visibility, and create a more holistic view of production. 

5.) Pick solutions that enable continuous improvement 

For many manufacturers in highly regulated industries, sacrificing continuous improvement for compliance is the cost of doing business. This is understandable when small changes can have unanticipated consequences. 

New digital tools, however, make it possible for manufacturers to have their cake and eat it too. 

Some examples will help me make this point. 

One medical device manufacturer used manufacturing applications in a validated facility to guide operators through a complex single-use kitting process. Given that there are over a billion  potential combinations of items, and each kit is unique to a patient, errors were common, and the cost of mistakes was high. 

This manufacturer built a single-use kitting application to make sure operators packaged each kit correctly the first time. Using IoT devices like break beams and pick-to-lights, these applications both increased the efficiency of each station, and reduced rework by 75%.

Tulip Kitting App
Single Use Kitting application


When the manufacturer needs to make changes to the application as production demands, they’re able to. The application platform’s architecture and permissions are such that end-users can’t change anything on the back end, nor alter the data collected as the apps run. 

Therefore once the platform was validated, engineers can make changes without triggering an audit. 

6.) Let digital technologies simplify compliance and reporting

In many facilities, creating the documentation needed for compliance is still a highly manual, paper-based process. While FDA regulations can require paper to be present at work stations, this doesn’t mean that digital tool can’t ease documentation. 

Tulip Electronic Logbook App
electronic logbook

For many manufacturers, the simplest use-cases for digital technology are Electronic Logbooks and Digital Batch Records. These applications record all necessary aspects of production, collect the necessary signatures, and document processes as they run. 

With these applications, compliance becomes a seamless part of the process. 

When it’s time for batch record review, all of the information is available and legible, saving time correcting illegible marks and preventing any loss of information across stages of production. 

If you’re curious how to get started with digital manufacturing in your regulated industry, get in touch for a free consultation with one of Tulip’s experts.