Scientist using digital tablet working in modern medical research laboratory.

How electronic batch records can improve pharma manufacturing

Review by exception creates an efficient review process with exception trends, reduced batch record review time and paper elimination.

In brief
  • Electronic batch record systems contain a unique functionality for quality review called review by exception.
  • This enables a more agile and reliable release process for manufactured pharmaceutical batches.
  • In the future, review by exception should become an automated process requiring less human interaction.

The digital manufacturing transformation has improved shop floor technologies by implementing data availability and predictive analytics through manufacturing execution systems (MES). In pharmaceutical manufacturing, MES most often means using electronic batch records (EBR) — a digital record that provides proof of a product’s batch record with details on process steps, equipment information, materials and supplies. The MES system is centered in manufacturing operations with connections to other foundational business and manufacturing execution systems, such as enterprise resource planning (ERP), process control systems (PCS) and laboratory information systems (LIMS). The EBR provides the guardrails to the drug manufacturing process to enable a safe and reliable execution process. This article explores four parts of MES:

  1. Core components
  2. Features and key benefits
  3. Success factors
  4. Next evolution

1. Core components

The components of an MES system provide functionality for the end user. e core value of MES can be described by the following five functionalities:

Pharmacist using tablet
Digital perscription
Filling a prescription on mobile in pharmacy
Image of pharmaceutical drugs in dish
Paying for prescription digitally

Equipment and resource management
  • Automatically track all equipment, material and personnel related information through EBR
  • Minimize manual transcription and maximize automatic flow of information from outside systems
Review by exception
  • Eliminate manual scrutinization of record
  • Automatic highlights outside of specifications
  • Reduce batch review cycle time from days to hours
Automatic Calculation
  • Reduce errors from manual calculation
  • Information transfer directly integrated from equipment
  • Reduce batch record execution time with automatic calculation
Weigh and dispense
  • Track and verify inventory to work-in-progress inventory
  • Generate material genealogy throughout the manufacturing process
  • Increase efficiency with integrated scales and procedures
System Integration
  • Designed to  be easily integrated to an ERP system or plant automation layer

2. Features and key benefits

The value in batch review by exception (RBE) isn’t just experienced by those in manufacturing; it also allows patients to release a product after cycle times. It enables a more efficient review process by only highlighting areas where an exception or “non-normal” event has occurred. This may not seem significant until one considers the sheer volume of a batch record — hundreds of pages filled with technical data derived from calculations and required quality verification signatures. Through a successful RBE implementation, one could reduce a 150-page batch record review to a three-page exception report with key exceptions highlighted. Table 1 below provides an excerpt of an exception that could be expected.




Risk level





Control limit violation



Out of tolerance

Process A, Unit B, Step C

John Doe 12/14/2022 14:21 EST

Table 1: Example of exception report details

End users of RBE will save time and money using these key features:

Medical imaging
Pharmacists working together
Medications at automated pharmacy system
Pharmacist selecting medications
Pharmacists viewing tablet
Pharmacist selecting medications

Exception generation

Content in the batch record that does not reflect the standard operating procedure (SOP) condition

Out of tolerance

Data entry errors during execution

Customizable exceptions

Review by exception with configurable risk classes to enable QA review for any relevant and/or required exceptions

Real-time review

Exceptions can be raised during in-process excecution of a work order, preventing further propagation of a deviation

Signature requirements

Review by exception is structured with the defined signature process to maintain complaince with batch record release

Exception dashboard

Exceptions are typically organized within a report that can be easily understood and analyzed for continuous improvement

The RBE management process creates a direct focus on the deviations that have occurred during the process, providing the right personnel with the most critical information. The review also has a predefined designated order of signatures to respect any approval workflows that must exist to release the batch record. Once RBE has reached a mature state, some key benefits will be realized:

  • Right-the-first-time records: RBE creates an emphasis on exception trends, providing the information of where to apply corrective actions in the process to eliminate deviations from occurring.
  • Reduction of cognitive load: By eliminating manual calculation and information transcription, quality assurance can significantly reduce batch record review time.
  • Paper elimination: Converting to an electronic system creates value by eliminating paper on the production floor during execution and in the file storage archives.


3. Success factors

The value of MES and RBE is tremendous; however, it is not simply achieved overnight. Going through the evolution of a paper master batch record (MBR) to an EBR can take several iterations of prototyping demonstrations and dry runs. This thorough design and review process enables end users to have a desirable batch record that can be executed without confusion or disruption. The execution of a well-designed EBR is only as successful as the training provided to the end user prior to go-live. Providing adequate and timely training to this audience is highly critical. Higher comfortability with the electronic system will also reduce the likelihood for unnecessary process exceptions to occur, minimizing extra work for quality assurance on the reviewing side. Involving the key end users of an MES system — manufacturing and quality — as early and as often as possible can largely attribute to a successful EBR and RBE deployment.


Lastly, a key consideration to fully taking advantage of RBE functionality will involve trust and taking leaps of faith with the new technology. The more elements of design, such as automatic calculation or electronic signature, that can be incorporated into the EBR design will result in more value generated in the RBE process. Early on, this journey might require some walking before running. The change management process is critical for end users to fully absorb the value of an RBE process in MES.


4. Next evolution

The transformation of batch record review from a full-manual process to RBE with an automated triggered review process has been a breakthrough. Allowing reviewers to see only process deviations provides them the ability to identify where continuous improvement opportunities can be implemented. Through RBE, it should be expected to see more analytics to identify reoccurring process deviations where corrective actions should be applied and the “right-the-first-time approach” can be achieved. With this framework in mind, human involvement in RBE should be reduced, but it will still be a key component.

Article includes contributions from Austin Amery, Manager, Business Consulting, Ernst & Young LLP.


Review by exception creates a more efficient review process by only highlighting areas where an exception has occurred. This allows reviewers to identify where continuous improvement opportunities can be implemented.

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