In medical device and diagnostic manufacturing, companies must keep a complete and accurate record of each product they produce in the form of a device history record (DHR). For those manufacturers using a paper-based or partially electronic system, maintaining complete and orderly DHRs according to U.S. Food and Drug Administration (FDA) 21 CFR Part 820 requirements is an inefficient process with inaccurate or missing information, poor data tracking, and other unnecessary risks.
A new white paper identifies some of the common pains that manufacturers face in their DHR processes, and it explores key ways an electronic DHR system can help to resolve these pains.
Common challenges among medical device manufacturing companies that have not automated their DHR systems include the following.
DHR processes conducted manually are inherently slow, cumbersome, and prone to errors. Yet most manufacturers still manage their DHRs via manual processes, meaning every step of the DHR process is conducted by a person and on paper. Examples of this pain point include:
What can manufacturers do to resolve inefficient DHR processes? Leveraging DHR automation can relieve some of the common problems associated with inefficient DHR processes in multiple ways, including: real-time DHR form validation; faster equipment maintenance processes that reflect best practices; and faster, more accurate product recalls should they be needed.
Manufacturers that rely on manual, paper-based DHR systems limit their ability to track manufacturing changes, identify quality events, and take corrective actions in real time. Insufficient tracking limits the potential value of this data and practically ensures the occurrence of bottlenecks, a critical problem if defective batches need to be identified:
An eDHR system with real-time nonconformance- and deviation-tracking tools can give manufacturers greater access to production data to make more informed decisions about deviations. It will enable manufacturers to improve their ability to report quality events, initiate corrective actions, access production data quickly, and achieve right first time (RFT).
Manufacturers continue to rely on multiple systems to monitor, collect and aggregate data across business operations, from enterprise resource planning (ERP) to learning management systems (LMS). Poor synchronization across the company’s systems can seriously limit the throughput between manufacturing and other critical business areas. If a manufacturer’s relevant systems are unable to communicate with one another, common DHR problems arise:
Robust eDHR tools can enable connections between systems, interfaces and people in some key ways: maintaining compliance in personnel training by verifying training requirements and proactively scheduling training; and facilitating productive connections between people throughout the entire company.
The life cycle of a medical device is long, and a product’s DHR may be needed long after customer use. Postmarket problems can arise, and without detailed production information on hand, both time and money are often wasted looking for a resolution. Details are critical in manufacturing, yet maintaining those details can be a challenge in numerous ways, including:
An eDHR software system can help manufacturers track all entered information accurately and ensure availability to all involved stakeholders throughout the entire product lifecycle. Especially for medical device manufacturers, maintaining accurate and accessible DHRs can be a lifesaver.
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