Quality Assurance Audit. Inspection To ensure compliance with GCP and all applicable regulatory requirements, Galderma Laboratories, L.P. may conduct a quality assurance audit of the site records, and the regulatory agencies may conduct a regulatory inspection at any time during or after completion of the study. The Investigator must agree to grant the auditor(s) and inspector(s) direct access to all relevant documents and to allocate their time and the time of their staff to discuss any findings/relevant issues.
Quality Assurance Audit. Heska agrees that upon a minimum fifteen (15) days notice from i-STAT, representatives of i-STAT, during normal business hours, shall be permitted to visit all locations where Heska maintains inventory of Products to conduct a quality assurance audit of such facilities and/or an on-site surveillance of the inventory storage tracking. i-STAT shall have the right during reasonable business hours, to inspect the books and records of Heska relating to Product complaint documentation. In the event that an audit reveals items that i-STAT determines should be corrected by Heska, i-STAT shall provide, in writing, within thirty (30) days of such audit, a list of such items and any proposed corrective action to be taken by Heska. Heska shall respond within fifteen (15) days of receiving i-STAT’s notification of the corrective action to be taken and an estimated completion date. If the parties disagree as to whether corrective action is necessary, the matter shall be resolved in accordance with the alternative dispute resolution procedures set forth in Section 11.9.
Quality Assurance Audit. Nuvelo will have the right to conduct reasonable quality assurance audits with respect to all facilities, operations and laboratories (and any records related thereto) operated by Bayer or its Third Party subcontractors, where Development activities are conducted, as is reasonably necessary solely for the purpose of verifying Bayer’s conformance with applicable GMP, GLP, GCP and other regulatory requirements in each country in the Bayer Territory. All audits initiated by Nuvelo will be conducted at Nuvelo’s sole expense, upon reasonable prior notice to Bayer, and during regular business hours. Bayer will have the right to conduct reasonable quality assurance audits with respect to all facilities, operations and laboratories (and any records related thereto) operated by Nuvelo or its Third Party contractors where Development or manufacturing activities for Licensed Product are conducted, including the right to audit activities that formed the basis of CMC documentation, only to the extent reasonably necessary for Bayer to carry out its Development and Commercialization obligations hereunder and as is reasonably necessary solely for the purpose of verifying Nuvelo’s conformance with applicable GMP, GLP, GCP and other regulatory requirements in the Nuvelo Territory. All audits initiated by Bayer will be conducted at Bayer’s sole expense, upon reasonable prior notice to Nuvelo, and during regular business hours.
Quality Assurance Audit. 1.1 AVL agrees that a Quality Assurance (“QA”) auditor to be selected by Adherex will be granted reasonable access to AVL’s facilities to conduct a QA audit at Adherex’s sole expense to evaluate the suitability of the Published Data for submission to the U.S. Food and Drug Administration or other equivalent regulatory agencies worldwide (the “QA Audit”).
Quality Assurance Audit. Lilly, at its own expense, shall have the right to conduct quality assurance audits with respect to all facilities, operations, and laboratories where work under this Agreement is conducted by Antares, or on its behalf by subcontractors, (including, without limitation, work conducted by Antares related to the Device Development Plan) and to verify Antares’ conformance with applicable cGMP, cGLP, cGCP, cQSRs and other regulatory requirements including, without limitation, verifying appropriate inventory control and material accountability systems with respect to the Device. Such audits shall only be conducted upon reasonable notice during business hours. Antares shall make necessary changes as required by such audit based on an action plan agreed to by the Parties. ***-Denotes portions omitted pursuant to a request for confidentiality under Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with the omitted information intact has been filed separately with the Securities and Exchange Commission.
Quality Assurance Audit. (a) ZGEN will have the right to conduct reasonable quality assurance audits with respect to all facilities, clinical sites, operations and laboratories (and any records related thereto) operated by Bayer or its Third Party subcontractors where Development or manufacturing activities for Licensed Product are conducted, including the right to audit activities that formed the basis of CMC documentation; provided, however, that such audits shall be conducted not more than once in any [ * ] ([ * ]) month period, other than “for cause” audits conducted in follow-up to findings of material deficiencies or critical observations made during previous audits, and such audits shall be limited to those portions of such facilities, clinical sites, operations, laboratories and records as are actually used for or related to Development or manufacturing activities for Licensed Product. All audits initiated by ZGEN will be conducted at ZGEN’s sole expense, upon reasonable prior notice to Bayer during regular business hours, and shall be subject to the confidentiality obligations of Article 14.
Quality Assurance Audit. Seller shall adhere to standard commercial practices in providing Goods. However, if there are any unique requirements, such as FFA or U.S. Government specifications required, the parties must mutually agree on such and specify on the face of an Order. With respect to quality, engineering, and manufacturing purposes only, Seller shall provide Buyer, Buyer’s customer, and U.S. Government or other regulatory agencies the right, upon reasonable written notice, to access and perform any inspection, test, audit, or investigation at Seller’s premises to verify compliance with the requirements of an Order. Notwithstanding the foregoing, Seller not be required to provide any of the foregoing parties with any business or financial related data, records, or other information.
Quality Assurance Audit. Lumara, at its own expense, shall have the right to conduct quality assurance audits with respect to all facilities, operations, and laboratories where work under this Agreement is conducted by Antares, or on its behalf by subcontractors, (including, without limitation, work conducted by Antares related to the Device Development Plan) and to verify Antares' conformance with applicable cGMP, cGLP, cGCP, cQSRs and other regulatory requirements including, without limitation, verifying appropriate inventory control and material accountability systems with respect to the Device, Prefilled Syringes and Products. Such audits shall only be conducted upon reasonable notice during business hours. [***]. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Quality Assurance Audit. Evidence showing that the Pharmacy staff have appropriate skills, knowledge and that they are up to date must be provided to Solutions4Health. Entries on PharmOutcomes must be accurate and reflect the nature of the consultation held. Number of safeguarding referrals will be retained in the Pharmacy for monitoring purposes. If there are any quality issues regarding the service delivered, Herefordshire ISHS will work with the pharmacy to improve outcomes and performance. The Pharmacy will be able to refer to the specialist service for further management of sexual health needs, which will include pathways for young and vulnerable people. All pharmacies must record all EHC consultations and prescriptions, using PharmOutcomes, including: Date of Consultation Client’s Date of Birth Client’s Postcode Completed EHC Consultation Form Exclusion form where appropriate and onward referral Solutions 4 Health will agree a timetable for regular monitoring meetings with each pharmacy, in order to review the performance of the contract. In keeping with the audit requirements set out in the PGD, an audit will be carried out within the first year, with subsequent re-audits to be agreed. The audit should include at least 20 sets of patient notes or 50% (whichever is smaller). A summary of the audit should be sent to the appropriate person as per Solutions4Health/PGD policy.
