July 19, 2018
How Do You Keep Pace with an Ever-Changing Regulatory Environment?
by Maureen Perroni
Do you feel like you are on a regulatory treadmill? Regulations are constantly evolving. You know that non-compliance can translate into significant fees, lost opportunities and unhappy customers. More change ahead is the only certainty that you have. How do you keep up?
New Markets, More Compliance Challenges
The well-known Porter’s Five Forces Framework together with the SWOT analysis help you take a look at your organization externally and internally.
Externally, in your expansion to other markets, new and different regulations apply. You need to move fast but smartly the first time. You cannot afford to lose sight of the regulatory landscape. If your labeling processes are not properly managed, you could end up taking a step backward.
The FDA, as well as other organizations around the world, often take a look at the label on your product as the first place to identify non-compliance violations. Fact is, regulatory bodies in countries like Russia and China may take severe action for first-time offenders in the form of confiscated or even destroyed product. It's wise that you know the ins and outs of regional regulations well before you engage in new business.
To better understand and navigate global regulations in the Medical Device industry, check out this on-demand webinar with USDM Life Sciences' Jay Crowley.
Same Markets, Ongoing Challenges
Even if you have no plans to expand into new markets, to keep up with regulatory compliance can be daunting. Regulations such as the FDA's Drug Supply Chain Security Act (DSCSA) and OSHA's alignment with the Globally Harmonized System of Classifying and Labeling Chemicals (GHS) are setting the bar high. The expectation is to ensure full traceability and proper identification of product, respectively, throughout the supply chain.
Considering this, how can you accomplish and sustain compliance fast? You can find the answers in the Regulatory Labeling Guide: 6 Best Practices to Sustain Compliance.
Old Silo Practices, More Mistakes
Internally, you may encounter teams that are not in sync. This practice jeopardizes accuracy and consistency in labeling, not to mention failure to meet regulatory compliance.
What if you're in the highly regulated Life Sciences industry where labeling solutions must be thoroughly validated prior to implementation? That can be an exhaustive and costly process akin to herding cats. Fortunately, there are ways to reduce the time and effort while ensuring deployment of a flexible, scalable labeling solution to meet evolving customer and regulatory demands. It starts with the Spectrum Validation Accelerator Pack.
Enterprise Labeling, Sustained Success
With Enterprise Labeling, you can safely run through the complex world of regulations in an efficient and agile way. Other companies on the regulatory treadmill have gone major distances with Loftware's Enterprise Labeling Solution, sustaining compliance while driving supply chain efficiency.
See for yourself. View this on-demand webinar during which you will learn how Perrigo, a leading pharmaceutical manufacturer with $4 billion in sales and nearly 10,000 employees, has streamlined its supply chain with Loftware Spectrum.