Modern electronic batch recording technologies are offering advantages over digitizing paper records while conforming to regulations
Technology and regulations often change the food and drug market. Although smart manufacturing is pushing a rapid development of smart machines and equipment and offering many new possibilities, the Food and Drug Administration (FDA) is also stepping up its enforcement of regulations.
Manufacturers are experiencing tough scrutiny across the globe and the spectrum of their industries, especially in quality control activities, safety reporting and manufacturing operations. Organizations have therefore started paying more attention to reduce risks through the implementation of strong management controls.
Electronic batch records (EBR) were once mainly used for helping pharmaceutical companies automate away the mountains of paperwork required for maintaining production batch records.
When part of the FDA specification known as 21 CFR part 11 was issued, production facilities were permitted to use EBRs to document each step in the production, packaging and handling of every batch of their products. Since then, industries started to realize how automating batch records can also help them improve workflows and efficiencies.
A GPS of Operations
By replacing paper-based with computer-based workflows, chances of getting human error are lowered and compliance processes speed up. However, EBR technology can do far more than digitize workflows and recordkeeping.
Some industry professionals describe EBR as a GPS of manufacturing operations because it can guide users to the desired destination, find the shortest trip, provide alerts to dangers, and give real-time feedback.
When integrated into a scalable manufacturing execution system (MES) such as Rockwell Software PharmaSuite® MES, EBRs become more dynamic and can support operations in new ways.
Especially when operations are moving to a Connected Enterprise, EBR can begin to access enterprise-wide information, deliver role-based instructions to workers and provide exception-based reporting.
Time-to-market is critical for pharmaceutical manufacturers who want to meet customer demands and maximize profits before patent and product expiration dates. There are multiple ways to accelerate time-to-market by using a modern and dynamic EBR.
The quality assurance (QA) teams can use its review-by-exception functionality to spot deviations much faster than scanning every record line by line to find them.
Not only can it speed up documentation review times and reduce the time required for releasing a product from the warehouse, but it also can improve batch accuracy and consistency.
Pre-validated recipe building blocks available in advanced EBR systems can be re-used to achieve shorter deployment times. Instead of time-consuming custom programming and validation, recipe authors can use a library of instructions to create new workflows in minutes.
Likewise, real-time information access creates opportunities to speed up processes throughout the production cycle. For example, gauge data can be automatically collected versus requiring a worker to physically walk to each gauge and record their readings.
The ability to collect and review process information helps make the identification and removal of unnecessary tasks such as redundant material checks and weight verifications easier.
Moreover, the time savings only become greater in a Connected Enterprise. The ability to connect an EBR system to mobile devices, for example, can give workers faster and more convenient access to information anywhere on the plant floor.
Uncover New Efficiencies
Lengthy compliance activities drive up the cost of production operations while the product sits waiting to be shipped. Additionally, human errors made during the production or documentation processes can result in wasted product or, worse, contamination and potential recalls.
Now manufacturers can use EBR technology to find new ways to optimize total cost of production.
Adopting an EBR system for compliance purposes immediately removes the time and costs associated with storing physical documents. Dynamic EBRs can expand on those savings — for example, by using automated QA functions to reduce the cost of researching process deviations.
Also, reducing the risk of human error combined with EBR features, such as enforceable workflows, can help prevent production or recording errors and reduce wasted product. Furthermore, preventing these errors can also help minimize the chance of expensive, brand-ravaging product recalls.
A paperless EBR system harnesses the power of automation and greater connectivity to help ease and even improve demonstrated compliance.
The FDA 21 CFR part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted. By integrating EBRs into an MES, manufacturers can automate manual documentation processes to reduce the likelihood of errors, such as miscalculations and false records.
The ability to integrate recipe and order information in a Connected Enterprise can help get the right information to workers as efficiently as possible.
For example, the system enables delivery of individualized, context-specific instructions to production operators, and enforcing processes and procedures, such as required sign-offs for 21 CFR part 11. And most importantly, in this era of Internet of Things (IoT), it can ensure all electronic records to be trustworthy and reliable.
In addition, EBR’s security features, such as role-based access, can help restrict production activities to authorized personnel.
Enhanced to Comply
Original equipment manufacturers (OEM) need to ensure that they and their customers are ready to meet the challenges of compliance as requirements change. Therefore, scalable human machine interface (HMI) software becomes critical to stay competitive while overcoming compliance obstacles and taking full advantage of the cost savings of electronic documentation.
FactoryTalk® View Machine Edition (ME) version 10.00 from Rockwell Automation is developed to address various demands of food and drug manufacturers flexibly and is added with functionality designed for applications that must comply with 21 CFR Part 11.
This latest version of machine-level HMI has a new onboard audit feature that records and stores operator’s actions locally. It also audits all tag writes and system actions, such as a user logging in to acknowledge an alarm.
The system can export the audit history, alarm history, and diagnostic log to a comma-separated values (CSV) file. This information can be used to generate an EBR.
A New Direction
Governments around the world are designing and implementing anti-counterfeiting regulations.
While the regulations each have their unique flavor, they share similar approaches in requiring manufacturers, not only in pharmaceutical but also other consumer packaged goods (CPG) sectors, to use serialization systems for product traceability and authentication.
Complying with these regulations will be critical for global manufacturers operating in multiple countries. With the growing need to reduce errors as well as overhead, along with effective process control and quality management, EBR technologies are developing rapidly and are set to continue seeing steady demand over the coming years.
Advances in EBR systems represent a new future filled with opportunities for manufacturers that are still reliant on paper-based reporting systems – opportunities to be compliant, more productive and more cost-effective.