GxP Lifeline Feature Article

How to Solve the Top Five Batch Record Challenges

By Oliver Wolf


Manual Batch Record Systems Waste Resources and Slow Product Time to Market

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:

  • Incorrect data entry.
  • Failure to recognize out of spec entries.
  • Missing signatures.
  • Filling out incorrect forms.
  • Sending the wrong form to the wrong person.
  • Forms left incomplete.

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:

  • The EBR structure should be based on the Instrumentation, Systems and Automation Society 's S88 model ( ISA-S88 ) industry standard. By incorporating an automated batch record system based on ISA-S88, you ensure that the foundation of your working model will be an FDA-compliant framework specifically designed to capture all data relevant to GMP compliance. The S-88 standard offers a structure for integrating and coordinating recipe-related information and makes allowances for flexibility and reuse of equipment. Adopting ISA-88 standards provides a blueprint model and terminology that can span across all departments.
  • The EBR system should be able to track active tasks using an electronic inbox.
  • Automated routing, follow-up and escalation of batch records should be possible.
  • The system should allow links to be maintained so users can review a completed process and readily see the event that triggered a particular process.
  • The EBR program must include robust reporting, including analysis, trending and data-mining capabilities. It should offer pre-configured and customizable forms. Pre-configured forms can simplify data collection and minimize errors.
  • Forms should be able to be signed and approved electronically. A flexible electronic system can convert forms from various common formats, such as Microsoft Word, Excel or Power Point so users will see the same form and reduce the need for training.
  • An advanced EBR system can handle a mix of parallel and sequential processing steps or unit procedures under the same recipe. All critical GMP compliance data in both master and control recipes should be able to be controlled by the EBR system.

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:

  • Improved batch-to-batch quality and consistency
  • Reduced cycle and review times
  • Increased employee productivity
  • Prevention of data transcription mistakes that may otherwise be caused by human error
  • Reduced scrap, diminished costs, and faster release lead time
  • As batches are released faster, the potential to generate more profit increases
  • Automatic creation of batch records results in improved performance of the entire batch record process

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 .

About the Author
Oliver Wolf, a product manager at MasterControl Inc., specializes in information systems and computer validation in the pharmaceutical and software industries.

Read more about electronic batch records and quality management:



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MasterControl Electronic Batch Records

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21 CFR Part 11 Risk of Non-compliance




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