Foolproofing Regulatory Document Generation
April 1, 2009
When it comes to managing regulatory documents like product labels, bills of lading and certificates of analysis, virtually all adhesive and sealant manufacturers face the same challenge: getting the right information into the right document format for every shipment. This challenge becomes more complicated when you ship to customers with unique labeling and reporting requirements.
But why is regulatory-document management such a challenge, and how can you take that challenge and make it an opportunity?
You Can't Blame One Person for All Your MistakesThe challenges of regulatory-document management are typically rooted in the type of technology used to run your business. Many adhesive and sealant manufacturers start out using multiple software tools, like spreadsheets and basic accounting systems. As business grows, more systems are added - a new lab management system, an inventory management system, etc. A separate system for regulatory reporting and labeling is often added to the mix as well.
For most companies, that regulatory reporting “system” is nothing more than a series of word processing documents. That means you have to rely on someone within your company - we’ll call her Cindy - to manage this manual process. With your data scattered across multiple systems, Cindy has to search several locations for the formula, batch and quality control (QC) information for each shipment. Then, because different customers may have different document specifications for the same products, she has to cross-reference the data with her customer files. Finally, she has to select the proper document format and accurately enter the information.
Beyond the obvious bottleneck, there is also potential for human error every time Cindy works on a new shipment. She may choose the wrong form, make a formatting mistake or enter incorrect QC/formulation values from time to time, which you will likely pass on to your customers. What’s more, returned shipments will inevitably re-enter your bottleneck, where similar mistakes can happen again. In this scenario, it won’t take long for your customers to start looking to your competitors for a more dependable supplier.
So the question remains: How can you ensure that your regulatory documentation always has the right data in the right formats?
The trick is to integrate all of your business processes - formulation, sales, purchasing, inventory, production, QC/QA, lot tracking, accounting and regulatory reporting - into one software system. Integrated Enterprise Resource Planning (ERP) software provides one location to manage all of your data, meaning there’s no need to re-enter information. In other words, ERP software provides greater control over your processes because it relieves you of your reliance on Cindy.
Building a Better Business ProcessWell-designed ERP software helps you get the right data into the right document formats by allowing you to configure regulatory document templates. The term ‘configure’ means you can adapt the system to your business without altering the basic programming code. Benefits of configurable templates include cost efficiency, quick installation and long-term ease of maintenance.
Modern ERP systems can even use the familiar functions of Microsoft Word to lessen the learning curve of document configuration. Using the data from your ERP system through the Word application, you can insert and arrange data fields, logos and other characters according to your own specifications to configure a document template for each regulatory form you use. This list could include product labels, COAs, MSDSs, packing lists, bills of lading, etc. In addition, depending on the complexity of your regulatory reporting needs, you could also configure product- and customer-specific templates.
The ability to configure regulatory document templates ultimately simplifies matters on your shipping dock. When your employees print the regulatory documentation for a shipment - whether it’s going to Cleveland, Canada or Kathmandu - the system would automatically populate the proper template with the proper data.
Simplifying Cindy's RoleWhile integrated ERP software eliminates redundant data entry, someone still has to enter QC data into the system as you run tests. This is a major problem when using multiple systems because it’s very difficult to apply process controls across several applications. But with one point of data control, you can establish rules that restrict data entry.
For example, QC reporting ranges can be set. If you set the reporting range for the pH of a product at 8.6-9.2, and 88 is entered instead of 8.8, the system would automatically stop the process. The user would be prompted to fix the mistake before moving on. If this data were entered into a side system, the user might not be able to catch the error. Process controls like QC reporting ranges are the only way to ensure accurate data.
A Science, Not a Science ProjectWhether you make one product for one customer or 1,000 products for 1,000 customers, regulatory reporting is an important part of your business. It gets your products where they’re going, keeps you in good standing with regulatory agencies and provides your customers with the data they need to run their operations effectively. By using ERP software that integrates configurable regulatory document templates with all your business processes in one system, you can turn the challenge of regulatory reporting into an opportunity to establish your company as a reliable supplier.
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