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A device history record (DHR) serves as a detailed record of a specific medical device unit’s or batch's production history. This record ensures the device was manufactured according to the device master record (DMR) specifications and adheres to regulatory requirements. DHRs typically include details like manufacturing date, quantity produced, equipment used in production, operator identification, component materials, quality control checks, and final approval signatures.
Electronic Device History Records (eDHR) systems have become essential in modern pharmaceutical manufacturing by providing comprehensive digital documentation of the entire production lifecycle. These systems enable real-time data capture, monitoring, and verification at each manufacturing step, ensuring consistent GMP compliance and streamlining regulatory reporting. By replacing paper-based processes, eDHR solutions enhance data integrity, facilitate faster batch release decisions through automated review workflows, and provide complete product genealogy and traceability. Additionally, eDHR systems support continuous process improvement initiatives by generating actionable insights from manufacturing data, ultimately reducing deviations, minimizing production errors, and improving overall quality assurance in pharmaceutical operations.
Electronic Device History Records (eDHR) systems serve as critical technology infrastructure in medical device manufacturing by digitally documenting each unit's complete production history from component sourcing through final testing. eDHR integrated platforms like MasterControl enable manufacturers to enforce strict adherence to predetermined manufacturing protocols, capture critical quality data, and maintain detailed records of all production activities and deviations for every serial-numbered device. In the highly regulated medical device sector, eDHR systems facilitate compliance with FDA 21 CFR Part 820 and ISO 13485 requirements while providing immediate visibility into production metrics and quality trends. The digital infrastructure supports efficient audit readiness, reduces documentation errors, enables prompt corrective actions, and ensures proper device identification and traceability—critical for product recalls and post-market surveillance. By centralizing manufacturing intelligence, eDHR solutions ultimately enhance patient safety while streamlining the device release process through automated verification of quality requirements.
The responsibility of maintaining an accurate and complete device history record typically falls on the manufacturing company, under the supervision of their quality assurance or regulatory compliance personnel.
Yes, electronic device history records are acceptable and increasingly common due to their efficiency and ease of access. However, they must meet specific requirements regarding electronic signatures, data integrity, and accessibility to ensure regulatory compliance.
Common issues include incomplete records, lack of proper documentation of production changes, discrepancies between the DHR and the device master record, and inadequate inspection and testing records.
Device history records provide detailed information about each batch or lot of a product, allowing manufacturers to trace and identify potentially defective products quickly during a recall process, thereby minimizing potential risks to patients and users.
Yes, the absence or incompleteness of device history records can lead to regulatory penalties, including warning letters, fines, and legal actions, as these records are essential for verifying compliance with manufacturing standards and ensuring product safety and efficacy.