Device History Records Sample Clauses

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
Sample 1
AutoNDA by SimpleDocs
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.
Sample 1
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 Xxxxxx'x written request therefore, Stellar shall furnish to Xxxxxx 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 Xxxxxx'x written request in connection with any Audit, make available for review by Xxxxxx during the course of such Audit, updates to the validation package for each Product.
Sample 1
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.
Sample 1
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.
Sample 1

Related to Device History Records

  • Inventory Records Each Loan Party keeps correct and accurate records itemizing and describing the type, quality, and quantity of its and its Subsidiaries’ Inventory and the book value thereof.

  • Research Records Each Party shall maintain records of each Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Research Program. All laboratory notebooks shall be maintained for no less than the term of any Patent issuing therefrom. All other records shall be maintained by each Party during the relevant Research Term and for [**] thereafter. All such records of a Party shall be considered such Party’s Confidential Information.

  • Maintaining Records The Borrower will record, summarize and report all financial information in accordance with GAAP.

  • Marking Records As of the Closing Date, Seller has caused the Computer File relating to the Contracts sold hereunder and concurrently reconveyed by Trust Depositor to the Trust and pledged by the Trust to the Indenture Trustee to be clearly and unambiguously marked to indicate that such Contracts constitute part of the Trust Corpus, are owned by the Trust and constitute security for the Notes.

  • Maintaining Books and Records Accurate books, records and accounts shall be maintained by the Partnership for each Restaurant and for the Partnership showing their respective assets, liabilities, operations, transactions and financial condition, as well as the names and addresses of the Partners. The Partnership’s and each Restaurant’s books and records may be kept under such permissible method of accounting as the General Partner may determine. The Partnership’s and each Restaurant’s books shall be maintained at the principal office of the Partnership, and each Partner shall have the right upon reasonable notice given to the Partnership to inspect, extract and copy such books during regular business hours of the Partnership.

  • Patient Records Upon termination of this Agreement, the New PC shall retain all patient dental records maintained by the New PC or the MSO in the name of the New PC. During the term of this Agreement, and thereafter, the New PC or its designee shall have reasonable access during normal business hours to the New PC's and the MSO's records, including, but not limited to, records of collections, expenses and disbursements as kept by the MSO in performing the MSO's obligations under this Agreement, and the New PC may copy any or all such records.

  • Business Records Keep, and cause each Subsidiary to keep, adequate records and books of account with respect to its business activities in which proper entries are made in accordance with GAAP reflecting all its financial transactions.

  • Accounts; Records The Servicer shall maintain accounts and records as to the Recovery Property accurately and in accordance with its standard accounting procedures and in sufficient detail (i) to permit reconciliation between payments or recoveries with respect to the Recovery Property and the amounts from time to time remitted to the Collection Account in respect of the Recovery Property and (ii) to permit the FRC Collections held by the Servicer to be accounted for separately from the funds with which they may be commingled, so that the dollar amounts of FRC Collections commingled with the Servicer’s funds may be properly identified and traced.

Time is Money Join Law Insider Premium to draft better contracts faster.