Audit Activities Sample Clauses

Audit Activities. Each Party and any designated third party, who is acceptable to the other Party, shall have the right to audit the other Party. The Parties need the right to audit all device- related vigilance activities, data processing and transmission in the Drug Safety Dept. of the other Party in order to monitor the compliance with the agreed procedures. This activity is to be done in accordance with the relevant provisions of the Agreement.

Audit Activities. In order to gather evidence of compliance with the legality requirements laid down in the legality grids in Annex II, the agency carries out checks at several levels: a) First-level documentary verification: checking the presence and conformity of all the documents listed in the verification manual. This includes: (i) verification of the presence of all legality documents in the data management system. Should any documents be missing, the agency asks the operator and, where appropriate, the authority concerned to provide them; (ii) verification of the conformity of the documents, including the conformity of stamps, signatures, dates and other formal elements, and the validity of the information contained in the documents; and (iii) verification of the operator’s internal traceability system using the functions of the data management system. b) Second-level documentary verification: on the basis of a risk analysis, the audit includes a thorough verification of the authenticity, conformity and validity of the documents. This thorough documentary verification includes: (i) verification of the authenticity of the documents with the authorities and bodies having issued them; (ii) verification of compliance with the procedure for issuing documents, including the procedure for issuing logging, processing and marketing licences; (iii) thorough verification of the data included in the verifiers, including cross-checks with other documents; and (iv) thorough verification of the operator’s internal traceability system. c) On-the-spot verification: on the basis of a risk analysis, each audit involves one or more on-the-spot inspections to verify whether the presence and compliance of the verifiers actually reflect compliance on the ground with the legality requirements laid down in the definition of legally produced timber given in Annex II. The risk analyses referred to in points (b) and (c) are performed by the agencies. They take into account the findings of previous verifications (of the same and previous audits), information provided or published as part of independent monitoring, complaints received in the complaint management system, any private certificates and other elements the authorities, the NFGC, the JIC deem relevant for this purpose. This means that the verification activities and timetable agreed upon by the operator and the agency at the kick-off meeting may be supplemented by additional activities and missions based on any elements discovered or com...

Audit Activities. 11.1 The activities implemented by the Grantee under this Agreement may be subject to audits by SPC, which may include audits of financial transactions and internal controls in relation to the activities carried out by the Grantee. 11.2 The Grantee shall instruct its personnel, including but not limited to its lawyers, accountants, auditors or other advisors, as well as its contractors and subcontractors, to cooperate within reasonable limits with any audits that may be carried out by SPC.

Audit Activities. If HMO has reason to believe that Vendor has failed to carry out any or all of the Services specified this Agreement, in accordance with the terms set forth herein or meet HMO’s reasonable performance expectations, HMO may take such steps, as it deems necessary, including, but not limited to, the following: 5.2.1 Audit Vendor’s performance of Services upon reasonable notice and during regular business hours or as otherwise provided herein. Vendor shall fully and promptly comply with HMO’s reasonable audit requests; 5.2.2 Require Vendor to submit, within a specified time frame, a corrective action plan to address any compliance or other problems identified by HMO. Vendor shall implement such corrective actions at its expense as reasonably directed by HMO as necessary to bring the Services into compliance with this Agreement, including, but not limited to, any applicable CMS requirements.