6 Core Capabilities Your Digital DHR Must Have

In medical technology manufacturing, organizations must maintain complete and accurate device history records (DHRs). For those manufacturers regulated by the U.S. Food and Drug Administration (FDA), the agency has made it clear. If the DHR doesn’t include complete information relating to the production and control of each lot or batch, the medtech manufacturer risks product quality issues or worse. Between 2017-2021, DHRs were among the top medical device warning letters issued by the FDA. ¹

When using a paper-based or partially digitized system to record all of the required information – dates of manufacture, quantities manufactured and released for distribution, acceptance records, labels, unique device identifiers (UDIs), and more – maintaining complete and orderly records per FDA 21 CFR Part 820 requirements can be an inefficient process.

Many medtech manufacturers think they have an electronic DHR (eDHR) system, but often it is 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. An incomplete eDHR system offers insufficient visibility, traceability, and data integrity, often resulting in product quality issues, recalls, warning letters, even consent decrees

3 Types of Incomplete eDHR Systems

Even when manufacturers have automated some core operations, critical production processes like the DHR are still paper-based or disconnected. According to one recent study, 62% of manufacturing executives surveyed said their organization uses pen and paper to track vital manufacturing steps, while 50% reported using spreadsheets or a computer on wheels. ³ In another, 83% of frontline manufacturing workers in the U.S. reported still using paper to follow work instructions or track their work. ⁴

In this context, eDHR systems that are incomplete still rely at least in part on paper. Examples of incomplete eDHR systems often in use today by medtech manufacturers include islands of automation, manufacturing execution system (MES) apps, and legacy MES.

1. Incomplete: Islands of Automation

   As time progresses, the equipment used in medical device manufacturing continues to evolve. Vendors make equipment that manufacturing organizations can use to consolidate multiple production steps, and this equipment typically includes embedded software. Although these intelligent devices can emit data and records documenting steps that were completed – inputs, processing steps, and outputs – the data and records are only part of the overall production.

   If the entire DHR must describe the complete process and the island of automation is electronic, then the remainder of the production process is paper- based. How do those get merged? Is there a single document? To create complete DHRs, companies with islands of automation typically print the digital portion and merge that paper with the paper-based records from the rest of the process.

2. Incomplete: MES Apps

   MES-like tools are now available and positioned like apps, supporting the creation of smaller, nimbler apps targeted at a specific part of the manufacturing process. For example, an app could be created to monitor and interact with equipment at the start of production. Similarly, an app could be created to help track and coordinate the packaging step at the end of production.

   If the entire DHR must describe the complete process and the island of automation is electronic, then the remainder of the production process is paperbased. How do those get merged? Is there a single document? To create complete DHRs, companies with islands of automation typically print the digital portion and merge that paper with the paper-based records from the rest of the process.

3. Incomplete: Legacy MES

   There is a longstanding view among manufacturers that a traditional MES is the only path to digitizing and automating the shop floor. Traditional MES software can be a powerful tool for automating production processes, improving traceability, error proofing, and lowering cost – in highly automated production environments and on high-volume or high-margin product lines.

   When a legacy MES is used for a portion of the production process, such as packaging, it is similar to an island of automation or an app: it is incomplete. All production capacity that isn’t automated using a legacy MES still has paper-based DHRs. While you can get a complete eDHR with a legacy MES, it comes at a high cost – time-consuming implementation, rigid process configurations, and difficulty scaling. As a result, it is often deployed on a limited number of product lines.

6 Elements of an End-to-End eDHR System

A complete, end-to-end eDHR solution enables smarter, faster manufacturing processes, so medtech manufacturers can make immediate performance gains at every step

A modern solution like MasterControl Manufacturing Excellence is designed to provide a complete electronic eDHR. The purpose-built solution digitally connects every step of the manufacturing process – not only a selection of the steps or a limited number of the production lines. This allows manufacturers to easily create the entire, beginning-to-end eDHR. And as a modern solution, it is designed with the mobile user and digital technology in mind.

Beyond digitizing every step of production, a system capable of yielding a complete, end-to-end eDHR incorporates six essential elements into the overall manufacturing process, as follows.

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. Crucial functionality for templates includes approval routing, watermarks and signature manifest, and version and revision control.

   Manufacturing Excellence allows manufacturers to templatize master eDHRs that have a familiar look to paper records, as well as easily adjust for different product variations. For the actual eDHR, that means a legible, auditable, and usable report, with page numbering and redaction capabilities. After all, when an FDA inspector asks to see the DHR, you should provide an eDHR that looks like a DHR, not a document that looks like a report produced from an enterprise resource planning (ERP) system.

2. Good Documentation Practice (GDP) Process

   A complete system will serve as a GDP guidance system for better data integrity, with integrated, data-driven prompts to improve outcomes from the beginning of production to the end.

   For instance, Manufacturing Excellence guides operators through work instructions and navigates corrections and signatures, both using proper GDP. It enforces numeric limits, controls, and thresholds with pop-up warnings and notifies operators of all open deviations and corrective/preventive actions (CAPAs). The solution’s training checks won’t allow an operator to perform tasks until they’re current on training, automatically tracking and enforcing training compliance – so quality managers don’t have to worry whether the training records of workers on the factory floor match DHR documentation.

3. Quality Review

   An end-to-end system makes total GMP document review-by-exception possible, with every step and human interaction digitized.

   A solution like Manufacturing Excellence lets reviews happen at the same time as production, eliminating line-by-line reviews at the end of production. A simple, easy-to-read dashboard enables the quick review of quality forms and the status of each. Medical device manufacturers are able to fix data-entry errors in real time and easily identify the issues creating exceptions. When production is finished, there are fewer issues needing review and only exceptions to processes and documentation need to be reviewed. Review-by-exception shortens review times from days or weeks to mere hours — significantly reducing lead time from lot or batch completion to product release.

4. Product Volume

   A complete system not only automates a single record from end to end, but also allows medtech manufacturers to easily manage hundreds or thousands of product variations.

   Manufacturing Excellence is designed around a highly configurable no-code master record builder that includes a global element library for efficient scaling. To fulfill the need for product variation management, it provides an integrated product family tool. Scalable templates enable consistency, mitigate change control, and provide real-time updates. The solution’s product family tool simplifies the management of product variations, substitutions, and change control from one master template. This means manufacturers can easily approve and apply product variations to their production lines directly from the master DHR and automate change control for related DHRs in a product family – 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, and a modern manufacturing solution will simplify software validation without compromising compliance.

   With Manufacturing Excellence, MasterControl employs a patented cloud validation model providing full testing documentation by release. The risk-based, automated approach to validation focuses on critical business processes. A guided wizard creates a customized validation plan for each customer based on unique usage and risk. A customer’s product enhancement review and risk for upgrades is consolidated into a single change control. For change control, MasterControl utilizes advanced patented technology to present the changes needed to be reviewed. Overall validation time is reduced from months to days, if not hours, and cost is reduced proportionately. These strategic efficiencies allow for simpler and ongoing upgrades and sustainable validation in the cloud.

6. Data Visibility

   A complete system digitizes, improves, and puts into context all production data for manufacturing workers. It captures all production data in one place and provides a single source of truth.

   Manufacturing Excellence provides work-in-progress visibility and traceability into production lines, batches, lots, and operator performance in real time, while reducing data entry errors throughout. Manufacturers can see the status of each production step, which lots are where, and who performs certain steps the fastest or with the fewest mistakes. This visibility enables proactive action rather than reactive action through faster and more comprehensive data analysis. By improving data integrity and increasing visibility and access, the complete eDHR system gives manufacturers access to better data to drive better, smarter business decisions.