Electronic manufacturing systems have been the choice for large manufacturing companies over the last twenty years. Electronic manufacturing systems are the industry standard for large pharmaceutical companies who are required to follow GMPs (Good Manufacturing Practices). While FDA legislation mandates GMP compliance for other industries such dietary supplements and medical devices, they may not have the resources to implement a software system that has the rigid requirements for electronic documentation and electronic signatures described in 21 CFR Part 11.
Small to mid-sized companies who manufacture regulated products, have been hesitant to implement an electronic manufacturing system for several reasons. The obvious reason for resisting change is the typically high initial costs involved from switching a paper-based system to an electronic system. Another reason is that many smaller companies used Excel spreadsheets for batch documentation and they do not want to spend the time converting them to another system.
Excel spreadsheets may be the right approach for many firms for managing their batch records. Excel has been around for many years and almost all computer systems have a Windows version or a Mac version installed. Most of the staff working in small manufacturing firms have at least a secondary education or a college education so they typically already know how to use Excel. The downside is that spreadsheets are kept on the hard drive of local computers or on company servers. This requires the staff to be using the specific computer where the spreadsheet is stored, or to be in the manufacturing facility when the spreadsheet is on a server and is only available through the company’s intranet.
There are numerous electronic batch record systems on the market which could be more efficient than Excel. Their advantage is that the offer both Master Records and Batch Records that are controlled, organized and easy to track. When working in Excel, most firms are generating master manufacturing formulas that are in a spreadsheet that is easy to copy into a batch record. The program, however, does not offer version control which is standard in electronic batch record systems. This means it can be easy for information in spreadsheets to get out of control and disorganized when there are many different products or batches being made in one facility.
In order to make the best choice on software and products to improve manufacturing, a company must truly know what the shortcomings of each option are and what they require from the system they select. A company should decide how much automation a facility needs based on what systems are already in place and functioning correctly. As an example, a company with an Excel solution for master records and batch records may not need to adopt electronic batch records if they make only a few batches a month. On the other hand, the same Excel solution may not be as efficient as electronic batch records if dozens of batches are made each month.
One of the most reasonable priced option for electronic batch records is InstantGMP™ MES. It is a 21 CFR Part 11 compliant data base system that works over the web that makes organizing, tracking and using electronic batch records easy.