How to Barcode Your Warehouse

7 Tips for User-Friendly Warehouse Barcoding. You want the advantages of a barcoded warehouse if you manufacture or package FDA regulated products. Especially if you have already suffered through the inventory spreadsheets, clipboards and cycle counts, or even the awkward interfaces of a current inventory “tracking” system– printing out [...]

How the FDA Publishes New Regulation (cGMP)

Smart companies use public information for strategic advantage. This article explains how new cGMP regulations are issued for pharmaceutical, medical device, e-liquid, and dietary supplement manufacturing industries. Since the most recent push for new regulation has been in the vaping and e-liquid space, we will use that industry as the primary example. On May 5, [...]

Proper Records Management Essential to FDA Inspection Readiness

Proper Records Management Essential to FDA Inspection Readiness The bio-pharmaceutical market is one of the most highly regulated industries and valued at $190 billion, it is no surprise to see why.  While increased regulation means more reliable quality assurance systems and safer medications for patients, it can be challenging terrain for manufacturers to navigate. Are [...]

7 Signs You Have Outgrown Paper Production Records

Using paper for your batch records has advantages. Paper acts as a bookmark for a process or a physical baton of responsibility. Paper is easy, it’s well accepted, and by sticking with paper batch records you won’t have to deal with any CFR 21 Part 11 electronic signature nuances. Plus, paper is “cheap,” right? Some [...]

Top 10 Reasons to Go Paperless

How many filing cabinets are you buying to keep every batch record organized in order to manufacture your products? Are papers piling up needing review? Are you ever missing any documents? (Am I describing every QA person’s nightmare?) Keeping records on paper is a necessary evil in many people’s minds. Today, there is not only [...]

Excel as a Batch Record

Excel as a manufacturing batch record tool Microsoft Excel®, as a part of Microsoft Office®, is used by 1.2 billion people. That means one out of every seven people in the world uses it. Excel moved beyond being just a finance tool years ago. Everyone from Inventory Management, Sales, and Manufacturing use this medium [...]