Brian Curran, SVP manufacturing excellence success, MasterControl, writes about why medical device and diagnostics manufacturers would benefit from eDHRs.
In medical device and diagnostic manufacturing, companies must keep complete and accurate device history records (DHRs). When using a paper-based or partially digitised system, maintaining complete and orderly records per U.S. Food and Drug Administration (FDA) 21 CFR Part 820 requirements can be an inefficient process with several common but unnecessary risks, resulting in product quality issues, recalls, warning letters, even consent decrees.
Today, 80% or more of all medical device manufacturing capacity uses paper-based DHRs, which causes too many problems and forgoes too many benefits available with modern systems.
While many manufacturers think they have an electronic DHR (eDHR) system, often it is only partial, or incomplete, because it isn’t end-to-end. While an incomplete eDHR system can provide some value, it won’t be complete in the context of the electronic record. The result is a lot of unfulfilled eDHR potential.
Common types of incomplete eDHR systems
Below are examples of common types of incomplete eDHR systems in use by manufacturers today.
1: Legacy MES
While you can get a complete eDHR with a legacy manufacturing execution system (MES), it comes at a high cost – time-consuming implementation, rigid process configurations, and difficulty scaling – so it is often deployed on a limited number of product lines. All production capacity that isn’t automated using a legacy MES still has paper-based DHRs.
2: MES apps
Modern MES-like tools support creating smaller, nimbler apps targeted at a specific part of the manufacturing process. Using different app-like MES tools for different parts of production can provide some value for the corresponding processes, but these apps are just part of the overall production and wouldn’t produce a complete eDHR. To create complete DHRs, companies are relegated to print the results from these apps and merge that paper with the paper-based records from the rest of the process.
3: Islands of automation
Vendors make equipment that companies can use to consolidate multiple production steps, and this equipment typically includes embedded software. While these intelligent devices can emit data and records documenting steps that were completed – inputs, processing steps, outputs – the data and records are only part of the overall production. If this “island of automation” is electronic, the remainder of the production process is paper-based. As with MES apps, to create complete DHRs, companies with islands of automation will print the digital portion and merge that paper with the paper-based records from the rest of the process.
What a complete, end-to-end eDHR system requires
A modern manufacturing solution is purpose-built and designed to provide a complete eDHR. Foremost, it creates a “digital thread” that connects every step of the manufacturing process – not only some of the steps (or some of the production lines) – to easily create the entire, beginning-to-end eDHR. Beyond digitising every step of production, the complete eDHR system will include additional elements of the manufacturing process, including the following six.
1: Electronic documentation
A complete system provides a master template and a DHR, with system functionality that supports the need to review, approve, and execute a master template to create the eDHR templates and final documents. For templates (input), that includes approval routing, watermarks and signature manifest, and version and revision control. For the eDHR (output), that includes a legible and auditable report, page numbering, and redaction capabilities.
2: Good documentation practice (GDP) process
A complete system should serve as a GDP guidance system for better data integrity, with integrated, data-driven prompts that: guide operators through work instructions using proper GDP; enforce numeric limits and thresholds; ensure operator training is always current; navigate corrections and signatures using GDP; and inform operators of related open deviations.
3: Quality review
An end-to-end system makes complete review-by-exception possible, with every step and human interaction digitised. Reviews happen in conjunction with production, so you don’t have to manually sift through papers to fix errors after the fact. When production is finished, there are fewer issues needing review and you can simply review exceptions to processes and documentation.
4: Product volume
A complete system not only automates a single record from end to end, but also allows you to easily manage hundreds or thousands of product variations. Manufacturing organisations have spent years and sometimes decades creating products and their associated paper-based product templates. A complete eDHR system should allow manufacturers to easily digitise not only a single record, but also hundreds or thousands of records. A product family tool will let manufacturers easily manage product variations, substitutions, and change control from one master template, ultimately reducing the number of needed templates by as much as 100:1.
5: Software validation
A complete system for medical device manufacturers must be validated. A modern manufacturing solution will employ a risk-based, automated approach to validation that focuses on critical business processes. The process leverages internal validation testing and advanced patented technology that accelerates overall validation time and allows for simpler upgrades and sustainable validation in the cloud.
6: Data visibility
A complete system captures all of the data in one place for a single source of truth. You’ll gain real-time work-in-progress visibility and traceability into production lines, batches, lots, and operator performance. See the status of each production step, which lots are where, and who performs certain steps the fastest or with the fewest mistakes. Take proactive action rather than reactive action by with faster and more comprehensive data analysis.
Conclusion
As medical device and diagnostics manufacturing becomes more data-driven and flexible, paper-based production systems are increasingly unsustainable. A partial DHR system yields partial digitisation, partial data, and partial visibility. Many manufacturing organisations are primarily running from the problems of paper, while the most advanced manufacturers are seeking the digital tools and data that can be used for continuous improvement. With a complete, end-to-end eDHR system, manufacturers can capture and leverage all of the data needed to comply with FDA 21 CFR Part 820 requirements and improve production and quality alike.
