CONTROL AND ASSURANCE Sample Clauses
The CONTROL AND ASSURANCE clause establishes the rights and procedures for one party to monitor, review, or verify the other party’s compliance with contractual obligations. Typically, this clause allows for audits, inspections, or the provision of documentation to demonstrate adherence to agreed standards or requirements, such as data security or quality controls. Its core function is to provide transparency and accountability, ensuring that both parties can trust that obligations are being met and risks are managed appropriately.
CONTROL AND ASSURANCE. CARE data are entered into the CARE eCRF, which can be accessed via the internet, allowing for remote data entry. The name of the eCRF system is secuTrial, a FDA/GCP compliant software containing an audit trial. The CARE eCRF is protected by a secure login. The data abstracted from the patient record may be adjusted/changed over time (in case these changes are decided and approved by the International Steering Committee of CARE). Responsible for the eCRF system (programming, hosting, login administration, data storage, data preparation for analyses) is the UNEV gGmbH ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ The CARE database was developed and is maintained by the UNEV gGmbH Data entries as well as changes made to data will be tracked by the audit trail of the eCRF system. Patient confidentiality will be protected. No personalized data, such as name, initials, date of birth, address are recorded in the registry. All data relevant to the registry are pseudonymized. For more details see also section 6.
CONTROL AND ASSURANCE. The Contractor shall produce and submit a method statement, project plan and quality control plan (QCP) to the Employer one week before work commences; and The QCP must indicate relevant hold, surveillance and witness points to be agreed upon by the EDWL System Engineer.
CONTROL AND ASSURANCE. (a) Lilly, or a third party under subcontract with Lilly (subject to receipt of any required FDA approvals), shall manufacture the Products in full compliance with the approved NDAs and in accordance with all Applicable Laws. Lilly shall perform quality control and quality assurance testing on Products to be delivered to Dura hereunder in accordance with the Specifications and the Requirements Document.
(b) Personnel from Dura shall, upon reasonable advance notice to Lilly, have access during normal business hours to Lilly's premises where the Products are being manufactured, tested, inspected, packaged and/or stored to observe and inspect the manufacturing, quality control and testing processes for, and the records of all production and quality assurance data related to, the Products. Personnel from Lilly shall have the same rights provided to personnel from Dura under this Section 3.2(b) if, prior to Lilly's transfer of the Licensed Assets to Dura pursuant to Section 2.4 of the Licensing Agreement, Dura (or a third party sublicensee of Dura) is manufacturing either or both of the Products.
CONTROL AND ASSURANCE. Unless otherwise specified, procedures, data collection and evaluation will be conducted as per the standard operating procedures of the CRO. The investigator will assume the responsibility of ensuring the completeness and accuracy of the clinical data. All data will be verified for quality control and will also be patient to audits from Tonix or designee to ensure quality.
CONTROL AND ASSURANCE. The CONTRACTOR shall furnish the ENGINEER with a copy of all mill orders, certified mill test reports and a certificate of compliance for all fabricated structural steel to be used in the work. Welder qualifications shall also be provided.
CONTROL AND ASSURANCE. The Contractor shall produce and submit a method statement, project plan (on MS Project) and contract quality plan to the Employer one week before work commences. The Quality Control plan must indicate relevant hold and witness points to be agreed upon by the EDWL System Engineer.
CONTROL AND ASSURANCE. (a) Hydro Med shall manufacture the Products in accordance with all Applicable Laws (including, without limitation, current Good Manufacturing Practices (cGMP)), its customary standards and practices at the Plant and in accordance with the Specifications for the Product.
(b) Personnel from ▇▇▇▇▇▇▇ shall, upon reasonable advance written notice to Hydro Med, have access to the Plant no more than once a month (except in the event that any Force Majeure Condition has occurred at the Plant, in which case ▇▇▇▇▇▇▇ and its representatives shall be entitled to have access to the Plant upon reasonable advance notice to Hydro Med) during normal business hours in order to observe and inspect the manufacturing, quality control and testing processes for, and the records of all production and quality assurance data related to, the Products.