Quality GxP Audits by Sponsor Sample Clauses

Quality GxP Audits by Sponsor. ​ (a) During the term of each Work Order, Worldwide will permit representatives of the Sponsor to audit any Services provided by Worldwide, to determine that the Services were conducted in accordance with this Agreement and the applicable Work Order; provided that the audit will take place at a reasonable time during normal business hours and reasonable advance written notice is given (i.e. no less than ten (10) business days prior to commencing an audit for/ or without cause, and subject to availability of relevant Worldwide staff and any prior Worldwide inspection or audit commitments). No-cause Sponsor audits are conducted at the Sponsor’s sole cost and expense. Any Sponsor audit may include review of: (i) the facilities where the Services are being, will be or ​ have been conducted; (ii) related Study documentation; and (iii) any other relevant information necessary for Sponsor to confirm that the Services are being or will be or have been conducted in conformance with applicable standard operating procedures, the specific Work Orders, this Agreement, and in compliance with applicable laws and regulations. Worldwide will provide copies of any materials reasonably requested by Sponsor during such Sponsor audit. The Sponsor representative conducting the audit of Worldwide under this section shall not be a Competitor of Worldwide. For purposes of this Section a “Competitor” of Worldwide means a service provider that performs services substantially similar to the services Worldwide performs for its customers and that is identified to Sponsor in writing prior to Sponsor’s notice of an audit – notwithstanding any CRO i.e. PPD, Syneos, IQVIA, Parexel, ICON, etc. shall be considered a ‘Competitor’ of Worldwide. ​ (b) Sponsor QA or its representative may conduct audits of a Site to enable Sponsor to assess whether the Services are being provided in accordance with this Agreement and shall work directly with such Sites and Worldwide’s project team in connection with such audit. Worldwide will in good faith and as requested by Sponsor in writing, assist Sponsor in obtaining the information requested, or required in the conduct of the audit. Sponsor shall not disclose to any third party any Confidential Information of Worldwide disclosed to Sponsor in the course of an audit except in accordance with the confidentiality obligations under this Agreement and in no event shall Sponsor disclose Worldwide Confidential Information to a Competitor of Worldwide. If request...
Sample 1
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Quality GxP Audits by Sponsor a) Supplier agrees that Client may conduct audits of Supplier’s premises to verify compliance with this Agreement. Any audits conducted by Client will be undertaken at a reasonable time during normal business hours with reasonable prior notice to Supplier (i.e. no less than [REDACTED: Time Period] prior to commencing the audit, and subject to availability of relevant Supplier staff and any prior Supplier inspection or audit commitments) These Client audits are conducted at the Client’s sole cost and expense and may include review of: (i) the facilities where the Services are being, will be or have been conducted; (ii) related Study documentation; and (iii) any other relevant information necessary for Client to confirm that the Services are being or will be or have been conducted in conformance with applicable standard operating procedures, the specific Statements of Work, this Agreement, and in compliance with applicable laws and regulations. Supplier will provide copies of any materials reasonably requested by Client during such Client audit. The Client representative conducting the audit of Supplier under this section shall not be a Competitor of Supplier. For purposes of this Section a “Competitor” of Supplier means a service provider that performs services substantially similar to the Services Supplier performs for its customers.
Sample 1

Related to Quality GxP Audits by Sponsor

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Quality Management Grantee will: 1. comply with quality management requirements as directed by the System Agency. 2. develop and implement a Quality Management Plan (QMP) that conforms with 25 TAC § 448.504 and make the QMP available to System Agency upon request. The QMP must be developed no later than the end of the first quarter of the Contract term. 3. update and revise the QMP each biennium or sooner, if necessary. Xxxxxxx’s governing body will review and approve the initial QMP, within the first quarter of the Contract term, and each updated and revised QMP thereafter. The QMP must describe Xxxxxxx’s methods to measure, assess, and improve - i. Implementation of evidence-based practices, programs and research-based approaches to service delivery; ii. Client/participant satisfaction with the services provided by Xxxxxxx; iii. Service capacity and access to services; iv. Client/participant continuum of care; and v. Accuracy of data reported to the state. 4. participate in continuous quality improvement (CQI) activities as defined and scheduled by the state including, but not limited to data verification, performing self-reviews; submitting self-review results and supporting documentation for the state’s desk reviews; and participating in the state’s onsite or desk reviews. 5. submit plan of improvement or corrective action plan and supporting documentation as requested by System Agency. 6. participate in and actively pursue CQI activities that support performance and outcomes improvement. 7. respond to consultation recommendations by System Agency, which may include, but are not limited to the following: i. Staff training; ii. Self-monitoring activities guided by System Agency, including use of quality management tools to self-identify compliance issues; and iii. Monitoring of performance reports in the System Agency electronic clinical management system.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Medical Procedures 21.01 The Board shall distribute a copy of its Operating Procedures for administration of prescribed medication to pupils in schools and Procedures for health support services to each Teacher. 21.02 In accordance with Operating Procedure Special Education Services 8, a Teacher may refuse without prejudice a request to administer medications except in life-threatening situations.

  • Technical Objections to Grievances It is the intent of both Parties of this Agreement that no grievance shall be defeated merely because of a technical error, other than time limitations in processing the grievance through the grievance procedure. To this end, an arbitration board shall have the power to allow all necessary amendments to the grievance and the power to waive formal procedural irregularities in the processing of a grievance, in order to determine the real matter in dispute and to render a decision according to equitable principles and the justice of the case.

  • Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Laboratory Services Covered Services include prescribed diagnostic clinical and anatomic pathological laboratory services and materials when authorized by a Member's PCP and HPN’s Managed Care Program.

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