GxP Lifeline
Solve These 4 Common Manufacturing Production Records Challenges
Life sciences manufacturers are having a hard time keeping up with digital trends. Electronic batch records (EBR) can greatly simplify production, but getting them traditionally required investing in an expensive, rigid manufacturing execution system (MES). This is no longer the case as a modern MES can provide the same benefits at a lower cost with easier configuration. With this newer option, you’d think manufacturers would all be implementing these solutions.
Our recent research found this wasn’t the case. While 57% of respondents have an MES, only 9% have it fully implemented at all facilities. This means most manufacturers are still struggling with manual manufacturing production records and processes that make it harder to meet regulatory requirements and get product out the door.
Manual Manufacturing Batch Record Issues
In our research, we asked respondents to indicate which issues they experience because of their manual processes. Oddly enough, there was a four-way tie for the top issue. The biggest problems, which were challenges for 64% of respondents, included:
- Process inefficiencies.
- Siloed production systems.
- Missing or unusable data.
- Compliance issues.
In day-to-day manufacturing operations, these issues culminate in more specific problems that can keep manufacturers from reaching their potential and earning the biggest profit with the highest quality products. The first of these comes from a problem that spans the quality/manufacturing divide: training.
Training Disconnect
Training is high on the list when it comes to the greatest compliance issues found during audits and inspections. Tracking training and enforcing it are difficult when you’re using a spreadsheet on an individual’s computer. That aspect of training is usually handled by the quality department, but without visibility on the manufacturing floor, it’s hard to know if only trained individuals are working on the line. Not only is there a lack of visibility into who’s been trained, there’s no way to prevent an untrained employee from filling out the manufacturing production record if your company literally uses paper.
These problems are solved with a modern MES that integrates with your quality management system (QMS). The connection between the two systems means that quality personnel can easily track who on the manufacturing floor isn’t up to date on their training and help them catch up. It also means that you can program your electronic batch record to not accept entries from a user that hasn’t completed the training. Then you’ll have the reassurance that every batch has been properly prepared and that the manufacturing production record will withstand scrutiny.
Data Integrity in Manufacturing Production Records
Another issue that’s directly tied to compliance is data integrity. According to the common ALCOA acronym, the principles of data integrity are that the data is attributable, legible, contemporaneous, original, and accurate. With paper manufacturing production records, trying to keep things legible is problematic. If you can’t read someone’s initials, attribution can be compromised and handwriting also means the data might be written inaccurately or misread. These problems vanish when using an electronic batch record.
Imagine never having to read a coworker’s handwriting again. Legibility is automatically guaranteed with an electronic system and since everyone has a unique username and electronic signature, attribution is also automatic. The electronic batch record can also be programmed to only allow certain data types and ranges, thereby preventing some human error. This also ensures that data is filled in as the operator completes tasks, making it contemporaneous.
Human Errors
To err might be human, but it needs to be addressed. Human error is one of the prime reasons for batch record review. However, when this is done on paper, it means going through hundreds, if not thousands, of papers, searching for errors. Finding those errors and correcting them takes a long time and keeps the batch from being released. Given the time-sensitive nature of some life sciences products, this is a big issue. And one that is solved with electronic batch records.
Electronic batch records include review-by-exception functionality. Instead of searching through the entire batch record, the system automatically pulls any fields that don’t meet specifications so they can be reviewed by quality. This can knock batch review down to just a few minutes from a days-long process.
Conclusion
Solving these manufacturing batch record problems is one way to give your company a competitive advantage. In fact, according to our research, 63% of manufacturers are moving forward with further digitization because it’s a competitive advantage. Find out more about how to improve manufacturing in your organization and get the numbers on what your life sciences peers are doing by reading the report “State of Digital Maturity in Pharma and Medtech Manufacturing.”
Sarah Beale is a content marketing specialist at MasterControl in Salt Lake City, where she writes white papers, web pages, and is a frequent contributor to the company’s blog, GxP Lifeline. Beale has been writing about the life sciences and health care for over five years. Prior to joining MasterControl she worked for a nutraceutical company in Salt Lake City and before that she worked for a third-party health care administrator in Chicago. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.
