Industry 4.0 and smart manufacturing are top of mind for manufacturing leaders and analysts alike. Associated with the cloud, big data, machine learning, the Industrial Internet of Things (IIoT) and predictive analytics, this new wave of connected digital technologies offers manufacturers unprecedented levels of data-driven insights, efficiency, optimization, product quality and productivity. The potential ROI is so promising, in fact, that more than half of all industrial companies have already invested in IIoT technologies as part of their digital transformation journey.¹  Yet a visit to almost any manufacturing floor reveals that error-prone and cumbersome paper processes are still alive and well. 

Despite the industry’s intense focus on current tech trends and initiatives, even the most forward-thinking manufacturers struggle to fully digitize, automate and integrate their operations, preventing them from leveraging the advantages afforded by these new technologies. For example, many companies continue to rely on manual, paper-based systems to maintain their batch records for compliance purposes. These inadequate systems expose manufacturers to several pain points, including inefficient processes, poor data tracking, inaccurate or missing information, and other risks. This often results in shipment delays, product quality issues, recalls, warning letters or even consent decrees.

To combat these pains and their associated risks, companies are looking to electronic batch record (EBR) solutions, the latest evolution in batch record management systems, which offer the robust functionality, enterprise connectivity and compliant traceability needed by highly regulated pharma manufacturers to realize their full potential.

Pain Point 1: Inefficient Batch Record Processes

For most life sciences companies, creating batch records is still a manual process. This means that every step of the batch record process — including filling out records, record reviews and batch record audits —  is conducted manually, by humans, and primarily on paper. At every step, these processes are slow, cumbersome and subject to human error. Companies that use manual batch record processes may encounter a number of issues, which can have real consequences on their ability to ship product, remain profitable and sustain audit by regulatory bodies.

Example: Missing Information in Batch Record Documentation
Batch records are complex: The complete record for a single production process may range from hundreds of pages with thousands of required fields, up to thousands of pages with tens of thousands of required fields. Using a manual process, each of these fields must be filled out in pen by an engineer or line worker during the manufacturing process, at the right time within that process, by the correct employee, and within the accepted range of values.

With this approach, errors are inevitable, including:

• Scribal errors: The person filling out the form may enter an illegible value or may physically smudge a number, making it unreadable during validation and review.
• Missing values: A batch record form may indicate that a value is required, but with a manual process, there is no way to enforce this requirement. As such, records may be returned with missing values, necessitating a time-consuming correction process.
• Illegal values: While missing values are a serious nuisance, values that are erroneous or fall outside of an acceptable range are even more tedious to correct with a manual process. The entered value must be crossed out, and a new value written in on the form, which may then have to pass physically between several employees before the batch record review can continue.

These types of errors can initiate a lengthy and costly nonconformance or deviation process, either during manufacturing or the review stage of the completed batch record between manufacturing completion and release. When multiplied across thousands or tens of thousands of data entry fields, the logistical complexity of implementing corrections can quickly become unwieldy.

Solution: Real-Time Batch Record Form Validation
By contrast, EBR solutions introduce flexible, streamlined, software-based batch documentation workflows that can integrate with and advance a company’s manufacturing processes.

Rather than having to wait until the review process to identify field entries that are incorrect, inconsistent or outside of the acceptable range, EBR software can perform real-time validation, which can speed time to market significantly. For instance, EBR systems can be configured to:

• Limit field inputs to a specific range.
• Forbid entering past dates without supervisor override.
• Verify that all required fields are populated before allowing the form to be marked as complete.

Pain Point 2: Insufficient Data Tracking

As manufacturing processes become more complex and new competitors arise in the global manufacturing industry, a company’s ability to intelligently collect, aggregate, filter and surface raw data from its batch records is the key to staying competitive and profitable now and in the future. This includes activities such as collecting real-time information from the factory floor, identifying bottlenecks and production issues, and evaluating test results.