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 »
Measuring time is one of the most critical factors to running any successful business endeavor. The Austrian School of economics favors the concept of low “time-preference,” or a long-term outlook for an enterprise. From the very start, an owner must be geared towards thinking ahead so they are ready to expand when new opportunities come. …
Manufacturers need to be able to complete every step of their business processes smoothly to deliver quality goods and services to their customers. If your software is clunky or unable to support your procedures, then it will hold you back and allow your competition to overtake you in terms of reliability and profit margins. The …
The Benefits of an ERP with End-to-End Processes Read More »
Technology is an interesting element in today’s ever-changing businesses. At one point, it was considered a gimmick, an additional tool that would have a minor impact. Yet, in the modern economy technology is a must-have for companies to fully function. Enterprise Resource Planning (ERP) software solutions have followed a similar path. Many firms were initially …
A cloud ERP is an information resource for your manufacturing data that allows you to make informed decisions about your business. With a cloud ERP, everyone has critical information at their fingertips. Without it, leadership is making decisions blindly, which can lead to losses that sink your organization. However, manufacturers looking to invest in a …
It’s after March 29, 2023. That means that the requirements outlined in section 524B, Ensuring Cybersecurity of Devices (section 3305) of the Consolidated Appropriations Act, 2023 (the “Omnibus” spending bill) start to come into play for medical device, equipment, and supplies manufacturers. Here, we will outline the new cybersecurity requirements from the Omnibus and what medical manufacturers …
FDA Mandates Medical Device Companies Must Prove Cybersecurity in 2023 Read More »
Manufacturing is in a labor shortage crisis. Nearly 76% of manufacturing leaders in the U.S. consider attracting and retaining a quality workforce to be their number one challenge, and Deloitte Insights anticipates that there will be a 2.1 million worker shortage in the U.S. by 2030. For manufacturers to succeed, they need to manage their …
Myths are a common part of the business world, even for the most remote subjects. Every industry has topics or information that delves into the world of bull. Not even outright lies, but general misconceptions about common knowledge. These may result in the spread of false information, poor brand image and even lost revenue. When …
There are a lot of problems that could be impacting your business. Information gatekeeping and departmental silos might be preventing your team from getting on the same page and working together. Without clear data and a 360-degree view of your organization, you may feel uncertain when making important decisions about how to move the company …
Excel, or spreadsheet applications like Google Sheets, are often the first data management tool reached for by manufacturers just starting out. Spreadsheet applications are usually already installed on your computer or are accessible for free, and they seem like an easy way to organize data. These tools may be able to get companies started, but …
Integrations should allow organizations to operate out of one system and offer a single source of truth for information. While integrations simplify business processes and foster collaboration, some manufacturers aren’t sure if they should use a fully managed integration or elect to maintain their system themselves. Here is why a fully managed integration is a …
Integration Maintenance: Fully Managed Vs. Doing It Yourself Read More »
Medical device, equipment and supplies manufacturing has higher production costs than other industries because of strict regulatory standards and the need for extensive product testing. These costs either lead to higher product prices for consumers or eat into profit margins. To gain a competitive advantage in a difficult market sector, medical manufacturers can reduce their …
How Medical Manufacturers Can Reduce Production Costs Read More »
As manufacturing becomes increasingly competitive, particularly for small and midsize businesses, resources like an ERP are essential for increasing efficiency, reducing downtime and unnecessary costs and streamlining business processes. However, it can be a significant challenge to choose the right ERP system. The right ERP will solve your problems, increase your competitive advantage and evolve …
Make-to-Stock (MTS) manufacturing is where producers make their items based solely on expected customer demand. Rather than a pre-planned production cycle, manufacturers predict the amount of orders based on individual products. To better anticipate what customers want requires a strong tool to determine important trends. Similarly, managing the complexities of your workplace requires a system …
Two Areas Where ERP Systems Improve Make-to-Stock Manufacturing Read More »
One of the most important principles for medical device, equipment and supplies manufacturers is risk management. Medical manufacturers are required to keep consumers safe and minimize risk by offering products that are reliable, work as expected and do not cause harm. These expectations are outlined by the FDA and ISO 14971. However, there are many …
