Device History Record (DHR) definition
Examples of Device History Record (DHR) in a sentence
A Device History Record (DHR) is to be maintained by SUPPLIER for assemblies of PRODUCTS.
Flextronics shall implement appropriate controls and processes to ensure that this traceability requirement is met, and associated records retained as part of the Device History Record (DHR) for the finished Product.
SELLER shall maintain a Device History Record (DHR) in accordance with 21 CFR 820.184 and shall provide ALCON with a right to audit and obtain copies of the DHR as may be necessary or reasonably useful to comply with requirements of the FDA or other governmental or regulatory authorities.
A Device History Record ("DHR") is to be maintained by the Supplier for assemblies.
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.
Insulet shall make the Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Insulet's other related quality systems records that are relevant to the Customized Insulet Device accessible to Amgen upon reasonable request and in support of all Regulatory Authority inspections.
Acceptance activities required by Purchaser for any particular finished goods or service via requirements that are contained in purchase specifications from Purchaser: included in or applicable to a purchase order, Statement of Work (SOW or contract) and Product Specifications, the Supplier will: • Include in their Device History Record (DHR) documented inspected, tested, or otherwise product verification as conforming to Purchaser specified requirements.
Additional topics for consideration: • Issuance, distribution, and approval • Product list number, lot number, and expiration date format • Retention of on-line retrieval and traceability capability (e.g. how long is it kept, where is it kept, turn-around time to retrieve data) • What happens to lot number assignment data when it “ages” off the supplier’s management information systems] Device History Record (DHR) [Describe which company has responsibility.