GxP Lifeline Feature Article
How to Solve the Top Five Batch Record Challenges
By Oliver Wolf
Life science companies' manufacturing processes should be assets?not liabilities. Although it is surely unintentional, too many companies treat their batch records like liabilities by using manual systems that are cumbersome, slow and often archaic.
The following is a list of five of the most common batch record problems manufacturers encounter and some possible practical solutions.
1. Manual batch operations are inherently slow and prone to error. Errors and omissions in batch operations are inevitable, but the constant checking and rechecking required when batch operations are conducted manually wastes money and slows time to market. As regulations get more complicated, batch records become exponentially larger and more complex, taking more time to prepare and review. Manual data entry from form to form creates lag time between departments and hinders general production processes. Some of the common snags that frequently delay manual batch operations include:
Solution: To reduce errors and speed up processes, consider implementing an electronic batch record system ( EBR ). An effective automated system should reduce manual data entry by automatically transferring pertinent data from one form to another. For instance, a streamlined system would automatically pass information from the Control Recipe to a Deviation, when such a process needs to be triggered. Some of the useful features to look for when developing or purchasing an EBR include:
2. Data located in separate repositories. In paper-based or electronic-paper hybrid systems, documentation is located in different, usually disconnected, storage areas. This prolongs and complicates reporting, trending and analysis.
Solution: Consider implementing a centralized, secure EBR system that can be integrated with applications that control other quality processes. If system users are given robust analytics tools, they will be able to leverage all data collected by the system for continuous quality improvement.
3. Risk. Because batch records are imperative to tracking and sustaining product quality, viability, and safety they are considered high risk data. Many companies view hard-copy paper batch records as a safety net for this vital data, the mindset being that minor errors can be corrected manually, even though it may take extra time.
Solution: An effective EBR system eliminates the need for a safety net by guaranteeing centralized access to real-time data. Implementing an EBR system is a long-term solution in that it provides simple yet secure access to consistent documentation throughout the manufacturing process . When evaluating the risks involved in switching to an electronic batch process, take these potential benefits of EBR into account:
4. Routing bottlenecks. Routing logjams are inevitable when using manual batch records processes. It is difficult to readily identify defective batches when one's time is spent physically tracking down logs, test results and other documentation.
Solution: A high quality EBR should be able to reduce bottlenecks by insuring that a continuous, uninterrupted stream of data is provided to users. Electronic forms can automatically track and record all routing information and supply batch coordinators with an overview of the complete process. Thus, it becomes possible to quickly identify bottlenecks and understand the sequence of events during processing.
5. Validation of EBR software seems like it would be costly and time-consuming. Many life science companies currently utilizing manual batch record operations would like to make the switch to an EBR system but have concerns that software validation is too costly and prolonged, which could negatively affect the return on investment.
Solution: If a company chooses an affordable commercial off-the-shelf ( COTS ) solution, the time and money spent on validation can be drastically reduced since most standard functions have already been pre-tested and validated. As Justin C. Iovino, director of business development at CimQuest stated in a Pharmaceutical Technology Europe article titled ? Design and Implementation of Electronic Batch Recording Systems ?: ? (V)alidation impact is reduced by the use of commercial off-the-shelf ( COTS ) products compared with custom-developed solutions because many of the standard functions must be tested by the vendor and are often considered validated or certified.? Validation efforts can be further streamlined if the organization already employs a risk-based approach .
For more information about batch records and the benefits to your organization of implementing an EBR system, visit the MasterControl website .
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