Documentation and Records. 9-1
9.1 Categorization of Documents 9-1
9.2 Document Review and Comment Process 9-1
9.2.1 Primary Documents (with Exception of Part B Permit Applications and Closure / Postclosure Plans) 9-1 9.2.2 Part B Permit Applications and Closure/Postclosure Plans (Operations and Postclosure) 9-5 9.2.3 Secondary Documents 9-5 9.3 Document Revisions 9-7 9.4 Administrative Record 9-8 9.5 Distribution of Documents and Correspondence 9-14 9.6 Data Access and Delivery Requirements 9-14 9.6.1 Data Reporting Requirements 9-14 9.6.2 Agreement Data 9-14 9.6.3 Validation 9-14 9.6.4 Non-Electronic Data Reporting. 9-15 9.6.5 Electronic Data Access Requirements 9-15 9.6.6 Data Delivery Schedules 9-15
Documentation and Records. The Employee shall hold in a fiduciary capacity for the benefit of the Company all documentation, disks, programs, data, records, drawings, manuals, reports, sketches, blueprints, letters, notes, notebooks and all other writings, electronic data, graphics and tangible information and materials of a secret, confidential or proprietary information nature relating to the Company or the Company’s business that are in the possession or under the control of the Employee. The Employee agrees that in connection with any research, development or other services performed for the Company, the Employee will maintain careful, adequate and contemporaneous written records of all Inventions, which records shall be the property of the Company.
Documentation and Records. VDOC will document all requests it receives for qualified interpreters and the action taken in response to each request, including denials of services. When an oral request for a qualified interpreter is received by VDOC personnel, the employee receiving the request will provide the inmate with an interpreter request form as soon as practical, but no later than one (1) hour from the time of the request, absent exigent circumstances, and the employee will help the inmate in completing the form where necessary. The documentation will be promptly provided to the United States for review of compliance with this Agreement upon reasonable notice and request by the United States, and included in the compliance reports required in “Monitoring and Compliance” in this Agreement.
Documentation and Records. 5.01 Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. At a minimum, all production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. X
5.02 Have written procedures for the review and approval of all batch documentation. X
5.03 Maintain a document control system for specifications and test methods, including: raw materials, Product labeling, packaging materials and other materials that would likely affect product quality. X
5.04 Review and approval of specifications and test methods, including: Product labeling, packaging materials and other materials that would likely affect product quality. X X
5.05 Provide a complete Certificate of Analysis for the Product, containing “at minimum” the following information: Supplier Product number Supplier lot/batch number. Name of Product Name of the tests Specification limit Expiration or retest date, if applicable Test result (as a numerical value, unless designated Pass/Fail in the specification limit, statistical values can be used if data supports their use except for assays and impurity tests), including retest results if required Quality Assurance approval and date. Manufacturing Site (name and address) Manufacturing Date X
5.06 Provide certification that the Product was manufactured in a cGMP compliant facility and was tested in accordance with and meets specifications X
5.07 Where applicable, electronic signatures used on the certificate of analysis or other controlled documents should be authenticated and secure. X
5.08 Archiving the original documents X
Documentation and Records. Creation and maintenance of documents and records to ensure regulatory compliance and conformity to company requirements along with appropriate confidentiality to protect privacy.
Documentation and Records. The Distributor will retain the documents and records concerning the marketing of the Product for the duration of the shelf life of the Product plus [****] year from the date of preparation (for the procedures, from the date when stopped using that procedure).
Documentation and Records. 7.2.1 The Provider shall keep accurate, current and complete clinical records for each client in accordance with applicable requirements.
7.2.2 The Provider shall provide client and service information to the ADAMH Board in accordance with applicable requirements. Payment for services shall not be made until documentation necessary to support the billing has been provided in accordance with applicable requirements.
7.2.3 The Provider shall adopt a record retention policy in accordance with applicable requirements.
Documentation and Records. The Supplier will promptly supply to KiwiRail appropriate documentation and other information for installation, operation and maintenance to enable KiwiRail to properly operate the goods or services and related systems, and freely provide updates to KiwiRail as and when they are produced.
Documentation and Records. 10.1 The Supplier shall maintain a documented quality system in accordance with the standards referred to in Annex 3.
10.2 The Supplier shall prepare and retain complete and accurate original batch documentation from the manufacture and quality control of each batch of the Material for GEHC.
10.3 Supplier shall keep a complete and up-to-date archive of manufacturing formulas, processing, sampling and packaging instructions/documentation, testing procedures, specifications, standard operating procedures, change control records and other procedures related to the manufacture and quality control of Material (which together with the records referred to in Clause 10.2 shall be known as the "Records").
10.4 The Supplier shall implement and follow efficient procedures for version control of the Records.
10.5 The Supplier shall store the Records in a safe and secure manner such that they are easily retrievable and reasonably protected from loss and damage.
10.6 Copies of the Records shall be made available to GEHC upon reasonable request.
10.7 Supplier shall keep all Records for a period of at least seven (7) years from the date of manufacture of the Material to which they relate.
Documentation and Records. 3.1 Certificate of Analysis will be supplied with each batch. X
3.2 Certificate of Analysis (including electronically generated certificates) will be prepared according to the Supplier’s procedures. X
3.3 Agree upon special Certificate of Analysis requirements as applicable. X X
3.4 If applicable, electronic signatures may be used according to documented procedures if they provide a degree of control equivalent to that given by a handwritten signature. X
3.5 Records required by the agreed upon quality system will be maintained for a period of 6 years from the date of supply. X
