Solution: 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 batch record process is the engine that drives productive connections and insights between manufacturing, QA and other operational units in a company.
Pain Point 4: Brittle Systems
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.
Example: 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: It takes time for paper batch record documents to be filled out, validated and filed. Sometimes, these delays can take long enough to alter a timeline and affect time-sensitive processes downstream in the manufacturing process.
- Lack of adaptability: Even if a production timeline has been adapted for a manual batch record process, this approach can limit the ability to respond in real time to changing conditions, such as equipment failure, variable ingredient quality, and ambient conditions such as humidity or temperature.
- Limited conditional responses: Batch manufacturing processes often include multiple branching paths depending on the source material and ambient conditions discussed above. Paper-based solutions are inherently less suited to this type of complexity because new documents must be prepared and maintained for each possible branch in the procedure.
Solution: Increase Flexibility and Adaptability to Environmental Changes and Process Complexity
Compared to paper-based systems, EBR solutions are inherently more flexible and can better adapt to environmental changes and all the dynamic complexity of pharma manufacturing processes.
Going Paperless: A Manufacturing Imperative
Across the manufacturing industry, more and more companies have recognized the importance of going paperless, many declaring it a corporate directive. Some have even begun filing their intent to go paperless with regulators. It is clear, however, that challenges persist.
As part of the current digital transformation movement, there is a need in pharma manufacturing to move away from the systems and methods of the past, and to embrace more advanced, efficient and compliant approaches to all manufacturing activities, including batch record management. EBR solutions are beginning to emerge that are robust enough to help companies realize tangible and significant operational efficiencies, while practically eliminating their regulatory burden of proof relating to batch records. This should be a welcome development for all pharmaceutical manufacturers, particularly those pursuing manufacturing excellence and the truly paperless factory floor.
1. “Quality 4.0 Impact and Strategy Handbook: Getting Digitally Connected to Transform Quality Management.” 2017. LNS Research.