Manual systems involve multiple forms and signatures to indicate compliance with the many process steps needed within the manufacturing and process area. This data will typically undergo a ‘first review’ on site and then a quality review when a batch is completed. In Europe, a third review is then undertaken by Qualified Person who specifically searches for exceptions and/or deviations. While much time and money has been spent on trying to improve productivity, the manual system remains inefficient by modern business standards. As usual when a company looks to reduce operational costs, an electronic solution is sought and developed. Electronic batch records (EBR) became a more viable option in 1997 when the FDA brought out its regulations in CFR 21 Part 11 on electronic signatures and electronic documents. That was a green light to software companies to add signature control functionality to their products.
EBR modules are now provided by software manufacturers that include functions such as form authoring tools, revision control, build in logic checks, data masks, task sequencing and work flow functionality which handles exceptions and deviations. It is also possible to obtain modules that include scheduling, time based event recording and automate adding steps to a batch record if required. Out of specification results, out of sequence operations as well as omissions can also be included to prevent an operator from continuing with a faulty batch.
The EBR systems can reduce time and costs compared to manually compiling and reviewing batch records as well as reduce errors, omissions and deviations, reduce lead-times and inventories. Establishing the necessary changes in the workplace though, can be very difficult and unless handled appropriately can and will lead to much dissatisfaction in the workplace. The EBR software by itself does not make the operation more productive. What it does is allow the processes to be re-developed and improved in ways that are not possible with manual systems. Project management and change management specialists should focus on process improvements, ensuring that relevant education and re-engineering of supporting processes are undertaken in a timely and skilful way with the input of those who are likely to be affected.
What to Look for When Choosing an Electronic Batch Record System
- Usability is crucial when selecting an electronic batch record system. Operators and other employees, even those at the management level, are typically less computer-savvy than office workers. Therefore, the system have an intuitive, navigable, and easy-to-learn interface.
- Since manufacturing processes vary greatly depending on the type of product a company produces, it is important to choose a system that is very flexible and configurable, or one that offers functionality for specific GMP operations.
- Make sure the system can make the manufacturing process more efficient and can improve product quality.
- An ideal system for GMP manufacturing will be easy to configure, be Part 11 compliant, will already be validated and have written operating procedures (SOPs) for the processes it controls.
Key Benefits for Your Company
- Facilitates best practices in production and manufacturing.
- Increase the accuracy in logs, inventory, bill of materials etc.
- Optimizes resource utilization and decreases overhead.
- Increases throughput and quality.
- Reduces product variations and defects.
- Increases margins and cash flow.