Much like the common cold or influenza weaken and wreak havoc on the human body, foiling our best-laid plans and taking us out of commission, paper-based processes slow and compromise an otherwise healthy and high-functioning pharmaceutical manufacturing operation. You can be ever so diligent at practicing the latest trends and proven remedies to keep your factory floor running on all cylinders and at its maximum performance – from digital transformation and lean initiatives to machine learning and robotic process automation. But if paper exists anywhere in the production process, the entire enterprise will remain susceptible to systemic, underlying infections like inefficient processes, poor data tracking, incompatible systems, and missing or inaccurate information.
The symptoms of this silent killer? Shipment delays, product quality issues, noncompliance and other far-reaching and damaging complications. Unfortunately, the prognosis is bleak for sufferers of paper-based batch records, progressing quickly from product recalls, to warning letters and ultimately leading to the worst-case outcome in weakened and high-risk cases: consent decrees.
To raise awareness of the widespread and debilitating paper epidemic among pharma manufacturers, a MasterControl white paper identifies the most common pains and symptoms indicative of an unhealthy paper-based batch record system, offers tips on how to treat each symptom, and presents the long-awaited cure for paper on the shop floor: electronic batch records (EBR).
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 several issues which can have real consequences for their ability to ship product, remain profitable and sustain audit by regulatory bodies.
Symptom: 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 such as scribal mistakes, missing values and illegal values are inevitable, and 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.
Treatment: 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:
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.
If a batch record process relies on paper forms that must be physically passed between multiple employees, it is simply not possible to efficiently catalog the large amounts of data required to support these analytic and diagnostic activities. As a result, the ability to track manufacturing changes, identify quality events and take corrective actions is limited.
Symptom: Limited Awareness of Quality Events and Delayed Corrective Actions
Batch record data is used for more than just anticipating and implementing deviation plans. It’s also essential for monitoring the output of each step in a manufacturing process and using this data, in turn, to analyze the quality of intermediate products. Batch reports that capture critical production/product data points such as ingredient information and observed values are the most important source for this data.
These capabilities are especially important in drug manufacturing, where seemingly small quality issues can quickly cause serious problems, up to and including a need to discard an entire batch in production. Furthermore, these issues are time sensitive when chemical processes are involved, meaning that QA engineers need immediate access to process data in order to signal quality events and initiate corrective action as soon as possible.
Treatment: Robust Quality Reporting and Corrective Action Potential
Until now, companies have had to make do with the time delays and practical limitations inherent to manual batch record processes, closing the door to significant gains in efficiency, speed and accuracy.
The ability to surface observations needed by engineers and QA teams to make real-time decisions about deviations, quality events and corrective actions can best be achieved with an EBR system. When batch record documents are filed electronically, the data contained in these documents is immediately available to relevant teams and to other parts of the manufacturing toolchain, such as an ERP solution. As a result, QA’s ability to report quality events and initiate corrective action procedures improves dramatically.
There is no one system that can guarantee manufacturing success or control every aspect of a complex, multifaceted manufacturing process. Instead, manufacturers rely on a set of systems that monitor, collect and aggregate data, such as ERP, MES or SCADA systems that surface observations from multiple business areas for use in manufacturing, purchasing and other activities.
The necessity of interfacing with multiple systems poses a potentially serious problem for companies that use paper-based batch reporting processes because these processes cannot connect with electronic systems, are subject to human error and scale poorly.
While a lack of communication between systems is by no means unique to batch record development processes, it is an enduring challenge in the manufacturing field. But because the batch record is at the heart of the manufacturing process as a whole, limitations here can have wide-ranging impacts throughout a company’s operations.
Symptom: Poor Collaboration Among Users and Quality/Manufacturing Departments
Manufacturing is an integrated process that relies on interoperability between multiple business areas. A disconnected, manual batch record system interferes with physical operations, but also with collaboration between team members and employees in different departments, such as that between quality and manufacturing, and between manufacturing and operations.
While these connections are certainly possible using a manual batch record system, the challenges resulting from poor synchronization and time-consuming data entry can seriously limit the throughput between manufacturing and other critical business areas.
Treatment: Create Connections Throughout the Company
If a company uses a manual, paper-based batch record development system, the pain — as well as the financial, time and personnel costs — of having disconnected systems that can’t effectively communicate with one another is evident. To resolve these issues, companies need a system that enables the creation of not only electronic batch records, but also connections between systems, data interfaces, and the people who make up relevant teams.
In an increasingly competitive and interconnected industry, manufacturing firms that don’t leverage all the resources within their business simply cannot remain competitive. A smart, software-supported electronic batch record process is the engine that drives productive connections and insights between manufacturing, QA and other operational units in a company.
Many types of manufacturing records keep data on what are essentially static processes that may be less sensitive to the exact timing or execution of a given step, or are not significantly affected by environmental conditions. By contrast, pharma manufacturing involves a variety of chemical processes that can be significantly — and harmfully — altered by any number of factors, such as temperature, purity and potency, or other environmental conditions like humidity.
Symptom: Difficulty Managing the High Variability and Dynamic Nature of Pharmaceutical Manufacturing
A paper-based solution for creating and maintaining batch records might not be able to handle the high variability and dynamic nature of pharma manufacturing, resulting in unacceptable delays, lack of adaptability and limitations in/limited ability to accommodate/capture conditional methods and responses.
Treatment: Increase Flexibility and Adaptability to Environmental Changes and Process Complexity
Compared to paper-based systems, EBR software solutions are inherently more flexible and can better adapt to environmental changes and all the dynamic complexity of pharma manufacturing processes.
Like the human body, a business is comprised of many critical components whose individual strength impacts the ability of the whole system to function at its full potential (think: “a chain is only as strong as its weakest link”). Batch records and other documentation are one of those components, and although they may not be as prominent as other production processes, batch records are essential to the collective health of your enterprise. They coordinate and inform your workers; establish, enforce and trace your processes; serve as a communication tool and system of record; and maintain order and compliance. Without them, pharma manufacturers cannot function.
Therefore, because it’s at the heart of your manufacturing process, your batch record system is a good baseline indicator of the vitality of the rest of your operations. Using manual, paper-based systems to manage your batch record processes is like hoping your immune system can ward off the cold, flu and other illnesses on its own. It might seem like a simple, inexpensive and sufficient solution, but even the most reliable immune system can be compromised, jeopardizing the body’s overall health and well-being.
The good news is, an over-the-counter “miracle drug” is now available that can cure your batch records pains. If your company’s efficiency, product quality and production output seem to be under the weather even though you’re doing all the right things to keep them strong and healthy, your paper-based or disconnected batch record processes might be the underlying cause. As with any potentially serious illness, prevention is the best medicine, but early detection and proactive treatment is the next best thing. It’s probably time to cure the disease by implementing an EBR software solution.
To learn more about curing batch record pains, read the full white paper.
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