Device History Records Clause Samples

Device History Records. PDEX will maintain documentation related to production history in Device History Records (“DHR”). Shipping and use documents will be maintained by MAKO per product serial/lot number.

Device History Records. A Device History Record will be established and maintained by {OEM Supplier} for each {Product}, service spare, and/or component product manufactured at {OEM Supplier}. Since there is typically no DHR for a subsystem, manufacturing records will be established and maintained by {OEM Supplier} for the subsystems and related spare parts. {OEM Supplier} shall provide a certificate of conformance indicating that the subsystem meets all agreed upon specifications and test criteria. Each Device History Record and manufacturing record will include, but is not limited to, the following applicable information/data: Configuration and revision level of manufacture Calibration and Test results Rework instructions if applicable Applicable deviations Service work records and testing All records required by {Company} manufacturing test records Final product labels applied to the instrument and accessories at {OEM Supplier} Review and signoff signature by a QA Representative

Device History Records. Service Provider will maintain documentation related to EPIK IMPLANT production history in Device History Records (“DHR”) per Service Provider internal DHR procedures. Shipping and use documents will be maintained by MAKO Surgical per product serial/lot number.

Device History Records. Device history records, including information relating to the manufacturing, packaging, and quality control testing and analysis for each lot of Finished Product produced hereunder will be prepared as and when Stellar or its Approved Manufacturer performs any such tasks. These records shall include, without limitation, the following: raw material and packaging or container/closure component release, mixing, and filling records, container and component tracing records, equipment usage records, in-process and final laboratory testing results, in-process and final physical inspection results, finished product and labeling reconciliations, labeling and packaging records, records relating to deviations from approved procedures, out-of-specification investigative reports and records. Device history records and all other records relating to production hereunder shall be retained by Stellar or its Approved Manufacturer for the longer of the duration of this Supply Agreement or the period required for meeting all rules and regulations of the FDA and other applicable regulatory agencies. Upon ▇▇▇▇▇▇'▇ written request therefore, Stellar shall furnish to ▇▇▇▇▇▇ for any calendar quarter during the Term of this Supply Agreement, a complete copy of the device history record for each production lot of Product produced during such quarter; provided, however, that Stellar shall not be required to furnish any such information on more than one occasion during each calendar quarter. Additionally, Stellar shall, upon ▇▇▇▇▇▇'▇ written request in connection with any Audit, make available for review by ▇▇▇▇▇▇ during the course of such Audit, updates to the validation package for each Product.

Device History Records. The CM agrees to establish and maintain a Device History Record (DHR) documentation process for each lot in compliance with the requirements of the ISO 9001 standard as it applies to all inspection and manufacturing activities related to Paltop product. Evidence of such compliance must be available to Paltop during the monitoring inspections of the CM. For every manufactured lot, the CM must document a complete DHR. Complete DHRs contain all required information to establish product traceability.