Compliance management is a top priority for companies in the pharmaceutical and medical device industries. You may think you have everything under control, but many companies don’t find out about the hidden dangers lurking in their process until it’s too late.
With this in mind, let’s take a look at the 4 biggest dangers hiding in your compliance management process, so you can take steps to address them before it’s too late.
Hidden Danger #1: Document Confusion
The foundation of any effective compliance management process is documentation. Test methods, product specifications, work procedures—these documents set the standard for everything that follows.
The problem is, many companies still use outdated methods to manage their documents such as shared network drives and email. You may think you have the most updated version of a given protocol, when the most recent version is actually buried in some months-old email chain. Or you go to download a key specification, only to realize it’s sitting on someone’s computer who doesn’t even work at the company anymore.
Document Control tools are essential for avoiding these types of problems, allowing you to:
- Centralize all controlled documents in one location, key to ensuring GMP and ISO compliance.
- Automatically route documents through review, update and approval phases.
- Go completely paperless, or combine hard copies with online document distribution.
Hidden Danger #2: Poor Supplier Management
Suppliers have a direct impact on your company, your brand reputation and your compliance record. You’re only as strong as your weakest link, and unfortunately for many companies, they don’t have visibility into what those weak links are.
Key supplier management capabilities to focus on around compliance include:
- Risk-based supplier ratings that help you quickly identify the costs and problems associated with individual suppliers.
- Supplier integration with your Corrective and Preventive Action (CAPA) process. Granting suppliers secure, permissions-based access to the CAPA system lets them take ownership of correcting problems they create.
- Creating automated alerts for supplier compliance events, keeping you up-to-date on how your supply chain impacts overall compliance.
Hidden Danger #3: Low Risk Visibility
Risk is one of the biggest hidden dangers in the pharmaceutical and medical device industries. It’s all too common for people to get bogged down in their daily to-do lists, spending so much time putting out fires that they don’t have the chance to look at the bigger picture.
Risk Management tools are critical for getting that larger perspective, helping you pinpoint problems before they occur. This is essential to shifting away from reaction mode towards a more proactive approach to compliance. Your compliance system should allow you to make any process a risk-based process, including:
- CAPAs: Filtering CAPAs by risk helps you find that needle in a haystack, ensuring you’re spending your time on the most critical issues. Risk-based verification also ensures CAPAs have reduced risk to acceptable levels.
- Planning: Predictive risk tools like Failure Modes and Effects Analysis (FMEA) and bowtie analysis help you make better decisions that systematically reduce organizational risk.
- Reporting: Risk is quickly becoming a universal yardstick for measuring compliance. While higher-ups may not understand the details of how individual departments operate, most everyone understands risk. That’s why reports that include risk are so helpful for streamlining communication and collaboration among company leadership.
Hidden Danger #4: Lack of Integration
Many companies use standalone point solutions for a variety of compliance management processes, thinking they have it all figured out because they have some shiny tool for CAPA, Document Control or Supplier Management.
In reality, all of these (as well as other key functions) are intimately connected within your overall compliance process. Without integration, you increase the chances of something falling through the cracks and creating problems down the road.
For example, document changes may require updating employee training, and any audit will most certainly uncover noncompliances that need to be entered into the CAPA system. While there’s a tendency to break processes down into manageable chunks, we can’t lose sight of how these processes are connected on a larger scale.
Ultimately, getting serious about compliance is all about making those larger connections. Once you do that, you can more clearly see the path forward, including the tools you need to help you get there.