Becky Lipnick

Working with trustworthy and reliable suppliers is critical for all manufacturers, but it is especially important for medical device, equipment, and supplies manufacturers. Your suppliers’ items must meet regulatory standards, otherwise, you will be held responsible. Don’t get trapped paying the price for your suppliers’ mistakes. In this blog, we will cover how medical manufacturers …

Managing an Approved Supplier List (ASL) for Medical Manufacturing Read More »

When inconsistencies permeate throughout your business, issues slip through the cracks. It is hard to recognize errors because you don’t have a clear vision of how you should be doing things. In contrast, mistakes are blatantly obvious in companies that have ironclad business processes where everything is being done the same way. When you create …

Creating Consistent Business Processes with ERP Read More »

Business processes need to adapt as your company and the marketplace evolves. Many companies are reluctant to change their business processes even when their growth rate has stalled because the status quo feels comfortable and worked in the past. “Just give it more time and things will bounce back,” employees may say. They may also …

Simplify Business Processes with ERP Read More »

Throughout every part of your organization, decisions have to be made constantly. Large and small, these decisions impact the success of your business, but it isn’t always clear what option to choose. Enterprise Resource Planning (ERP) clarifies what direction to take by offering complete data visibility. Here are a few of the biggest decisions you …

How ERP Improves Decision-Making Read More »

Manufacturers have a data problem. Every company has to deal with data, but it can be overwhelming to decipher what the information actually means. In turn, it is impossible to know how to best move your business forward if you are not confident in what your data indicates. Business intelligence (BI) can provide the analysis …

What is Business Intelligence? Read More »

For medical device, equipment, and supplies manufacturers, postmarket surveillance (PMS) is an essential part of product life cycle management. Some manufacturers avoid creating a postmarket surveillance plan until after their products are approved, forcing them to scramble to come up with something before their release dates. Planning at the last minute tends to lead to …

Managing Postmarket Surveillance for Medical Devices with an ERP Read More »

The more myths are repeated in business, the more they can become “established fact.” Trying to separate the truth from lies can seem like a challenge in itself. After all, the most ridiculous ones often sound both legitimate and verifiable. Enterprise Resource Planning (ERP) systems continue to be subject to all kinds of distortions. Despite …

Three More ERP Myths Debunked Read More »

For companies running on legacy Enterprise Resource Planning (ERP) systems, updating is always a potential reality. At one point, an owner must realize that their solution is no longer keeping pace. The realities of business are increasingly shifting, making operations a hassle. In some cases, the selection is archaic and unable to be managed effectively. …

ERP Upgrades and Data Migration Read More »

Manufacturers look to an Enterprise Resource Planning (ERP) solution for multiple reasons. An ERP can lead to faster customer service, solving major challenges like inventory management, or fostering coordinated efforts to streamline workflows throughout the organization. At the core of all of the main reasons to switch to a new ERP is one overriding factor, …

ERP and Simplification Read More »

Technology offers us increasingly greater interconnectivity through mobile devices. Growing manufacturers can take advantage of our heightened capacity to work from anywhere with a flexible Enterprise Resource Planning (ERP) system. With an ERP optimized for mobility, businesses can operate in ways never before possible to become industry leaders. Device Flexibility Over the past few decades, …

How ERP Offers Mobility and Flexibility Read More »

Quality management is essential for medical manufacturers because it impacts every aspect of their organizations. In this highly competitive and critical atmosphere, quality issues easily have the potential to sink medical device, equipment or supplies companies. Instead of making quality management feel like a burden, an ERP can simplify quality management so that your team …

How Medical Manufacturers Gain Quality Management with an ERP Read More »

ERP myths are everywhere in the manufacturing industry. Companies want the boost in sales, cost reduction and data transparency an ERP brings, but these myths can hinder organizations from taking the next step. Don’t let a false narrative hold your business back from reaching the next level with an ERP solution. In this blog, we …

Top ERP Myths: Part II Read More »

In implementing an Enterprise Resource Planning (ERP) solution, many factors come into play. One of the most prominent is the potential customization of your selection. These are additions specifically included in the installation as requested by the client. While some may be surprised, this isn’t uncommon for those purchasing an ERP. Most ERP implementations feature …

ERP Customizations: An Overview Read More »

The CAPA process is one of the biggest points of concern for medical device companies. CAPA (corrective and preventive action) is always evaluated during FDA inspections, so it is unsurprising that so many 483s and FDA warning letters focus on CAPA. No one wants their organization to get in trouble with the FDA because of …

Setting Up CAPA with an ERP: Inquiry and Assessment Read More »