With the technological systems development that has been occurring over the last twenty five years or so, the move to electronic manufacturing is currently in full swing, to the extent that it is now the industry standard in large manufacturing companies. Electronic manufacturing systems have been used in GMP (Good Manufacturing Practices) operations. Compliance with GMP requirements is mandated by the FDA for Active Pharmaceutical Ingredients (API), prescription drugs, generic drugs, over the counter drugs, veterinary drugs, medical devices and dietary supplements so the FDA has increased their scrutiny of EBRs.
While the benefits are clear, there is continued resistance to using electronic manufacturing in small to mid-size enterprises and in the contract manufacturing organizations that make regulated products. One issue which is immediately apparent is the cost of making the change from traditional paper based manufacturing.
There are many systems available which offer electronic solutions, however choosing one which will meet a company’s requirements is another matter. The return on investment has to be significantly greater than the cost and has to solve problems that could not be addressed in traditional manufacturing systems. Costs have to be measured in terms of initial price, maintenance fees, staffing requirements for a new systems and the loss of productivity associated with installing a new system and training an organization on how to use it. There can be huge costs in both financial and human terms as staff struggle to adapt to changing from traditional paper based system.
One must consider how much system automation is really needed. There are electronic solutions for batch records, for quality systems, for manufacturing execution and for enterprise resource planning. This wide variety of electronic manufacturing solutions would seem to create complexities that are perhaps as broad as the issues they are supposed to fix. The best electronic solution is one which will provide the maximum functionality to address all existing systems in one suite while causing the minimal disruption.
What are the options?
Electronic Batch Records: these are software products intended to supervise and document batch activities driven by electronic recipes. Examples are Batch Master, InstantGMP, Master Control, Mar-Kov CMS, Recipe Manager and Syncade EBR.
Enterprise Quality Systems: these optimize quality, ensure compliance and manage all quality processes in a centralized database from detection to corrective action to trend analysis. They identify high-risk events, then mitigate or prevent them through integration, automation and collaboration. Some examples are TrackWise, MAN-IT and CATSWeb.
Paperless manufacturing: this software will handle the company’s processes such as registration, documentation and validation electronically rather than with hardcopy/pen and paper. Their aim is to facilitate the movement of information within the organization (different departments) and outside the organization (investors and suppliers). Examples are Kneat Gx and VALDATA.
Manufacturing Execution Systems; these systems were considered the most promising remedy to solve manufacturing problems by directly connecting all of a manufacturing business’s operations to one data base. Examples are Werum, Honywell POMs, aspenONE, HITPHAMS and XFP Suite from Elan)
Enterprise Resource Planning: with these, manufacturing is merged into a information system that directly connects all the departments within the company so that they can easily transfer and share information. It creates synergy within the company since they include software for business development, accounting, production, purchasing and human resources. Examples are SAP, Ross Enterprise and Epicor.
Our experts prepared a series of review articles that describe the various electronic batch record systems and suggest which ones might be appropriate for different size companies based on their requirements and their ability to manage the changes needed to adopt a new way of managing their GMP production operations.
We invite you to leave a comments or reviews of these systems. There is a reply box at the bottom of each page so you can let us know what you think of the electronic batch record system. We appreciate your feedback and we expect it will help other potential users to make a good choice when they decide to use electronic batch records in their manufacturing operation.