Electronic documents and records. Where electronic systems are used for the control of documents, the system must be validated to ensure that only approved documents are made available at the point-of-use, write protection is provided, and approval forgery is prevented. Where records are stored electronically, the system shall have appropriate controls to ensure that only true copies of records are stored and controls in place to preclude unauthorized changes and loss. G. Safekeeping of paper documents and records. All required documents and records that are maintained in paper form shall be stored and maintained to ensure documents remain legible and identifiable.
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Electronic documents and records. Where electronic systems are used for the control of documents, the system must be validated to ensure that only approved documents are made available at the point-of-use, write protection is provided, and approval forgery is prevented. Where records are stored electronically, the system shall have appropriate controls to ensure that only true copies of records are stored and controls in place to preclude unauthorized changes and loss. G. Safekeeping of paper documents and records. All required documents and records that are maintained in paper form shall be stored and maintained to ensure documents remain legible and identifiable.
Appears in 1 contract
Sources: Manufacturing Agreement (GenMark Diagnostics, Inc.)