Surveillance Audits Sample Clauses

Surveillance Audits. 3.9.1. The purpose of this audit is to perform a detailed review in order to determine whether the management systems and infrastructure conditions provided by the company for the product or service continue to conform to the requirements of (EU) 2017/745 Regulation as well as the effectiveness of post market surveillance, clinical follow-up and vigilance systems created by the company for the continuation of the product and service safety and performance and availability of parallel implementations as declared by the company. 3.9.2. Some of the sections may be left outside the scope during surveillance audits but SZUTEST Konformitätsbewertungsstelle GmbH must have assessed all the relevant points that are required to be assessed in a certification cycle which is 5 years. 3.9.3. The first surveillance audit shall be performed in maximum 12 months after the certification date. Other following routine surveillance audits shall be performed in maximum 12 months after the previous surveillance audit however SZUTEST Konformitätsbewertungsstelle GmbH may choose to perform early surveillance audits. 3.9.4. Surveillance audits may cover testing where necessary. Samples may be taken from the company or market and tests may be performed either by using company’s existing capabilities or by using 3rd Party test laboratories.
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Surveillance Audits. On-site Surveillance Audit is conducted at least once in a calendar year. Surveillance audits in the first and second years following the certification decision. The date of first surveillance audit following initial certification is not more than 12 months from the Certification Decision Date. The time frame for 2nd surveillance audit can be extended up to 60 days for some justified reasons (for example plant is shut down due to up-gradation or major breakdown in plant/machinery) to assess the clients continued compliance to the requirements of standard. If this time frame will be extended, client’s certificate will lead to suspension. Internal audits and management review; Review of actions taken on nonconformities identified during the previous audit; Complaints handling; Effectiveness of the management system with regard to achieving the certified client’s objectives and the intended results of the respective management system (s); Progress of planned activities aimed at continual improvement; Continuing operational control; Review of any changes; Use of marks and/or any other reference to certification Additional requirements as per Applicable Standard for selected certification Audit plan & annual update (Onecert International) can also ask for necessary details to be reviewed, if required) is sent to client before 120 days of expiration of certification. A 2nd reminder is sent after 15 days of 1st reminder & thus next reminder after next 15 days of 2nd reminder if still any response is not received then a notice of proposed suspension is send if still client does not respond than certification is suspended.) Recertification audit is conducted in the same manner as of initial certification audit within every 3 years but before the expiry of certification, and if there is any significant changes in the client’s certification management, stage 1 audit is required. To re-assess the certified client’s management system continual fulfilment of all of the requirements of the relevant management system standard or other normative document. The Recertification Audit Should Include: To confirm the continued conformity and effectiveness of the management system as a whole, and its continued relevance and applicability for the scope of certification. The review of previous surveillance audit reports and consider the performance of the management system over the most recent certification cycle To check the effectiveness of the management system in its entirety i...
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Surveillance Audits. UL Solutions Contracting Party’s surveillance audit service, and any audits conducted by UL Solutions Contracting Party, are designed to serve only as a verification of continued compliance of the organization’s management system with the Service Agreement and the applicable Program Requirements.
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Surveillance Audits. 3.3.1 It is a condition of this Order/contract that where appropriate, the Buyer, the Buyers Customer and regulatory authority reserves the right to conduct Surveillance Assessments/Audits of the Seller and to inspect any airworthiness approvals / certificates / log cards and Buyers work in progress. This will be applied by agreement in the following instances, but not limited to, the following:
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Surveillance Audits. Having issued the certification licence, BOBS shall conduct surveillance audits of the Client’s management system in order to verify continued compliance with the standard. BOBS shall carry out scheduled bi-annual surveillance audits. The first surveillance audit shall be conducted six (6) months from the date of the Stage 2 audit. Where at least six months has elapsed prior to issuance of certification, following the Stage 2 audit, the first surveillance audit shall be conducted within the first month of issuance of certification.
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Surveillance Audits. After the issue of a certificate, in order to maintain registration, scheduled surveillance visits will be carried out at the client's premises at least once per year. If serious conformity or performance issues are identified, more visits may be required at the discretion ISOQAR. The client must agree to meet the additional costs relating to such increased surveillance. In exceptional circumstances, after complaints etc then some visits maybe unannounced on site audits.
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Surveillance Audits. 3.9.1. The purpose of this audit is to perform a detailed review in order to determine whether the management systems and infrastructure conditions provided by the company for the product or service continue to conform to the requirements of (EU) 2017/745 Regulation as well as the effectiveness of post market surveillance, clinical follow-up and vigilance systems created by the company for the continuation of the product and service safety and performance and availability of parallel implementations as declared by the company. 3.9.2. Some of the sections may be left outside the scope during surveillance audits but SZUTEST Konformitätsbewertungsstelle GmbH must have assessed all the relevant points that are required to be assessed in a certification cycle which is 3 years. 3.9.3. Surveillance audits must be performed minimum once a year however first surveillance audit must be completed within 12 months as from the certification starting date. Surveillance audits may be performed at a time earlier than 12-month periods if necessary. Surveillance may be postponed in case of acts of God, epidemics, organizational problems and similar conditions not attributable to the company. In those cases, the approval for postponement shall be given by the Certification section.
Sample 1
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Surveillance Audits. Periodic surveillances shall be carried out and shall cover aspects of the management system, documentation, manufacturing and distributing processes and products, depending on the type of certification services provided, at the discretion of the nominated auditor. Usually these will be 6 monthly intervals for large organizations or high-risk processes or at some other frequency as agreed with the company provided that the visits shall be conducted at no less than once calendar year, which will usually be applied to smaller companies and low risk processes. In particular, the first surveillance audit must take place within the first 12 months after the conclusion of the Stage 2 audit completion date. The Client shall give access to all sites or products for surveillance purposes whenever deemed necessary and the Certification Body shall reserve the right to make unannounced visits as required. The Client shall maintain a register recording all customer complaints and safety-related incidents reported by an enforcing authority or users relating to those covered by the Certificate and make this available to the Certification Body on request. The Client shall be informed of the results of each surveillance visit. The Company shall also conduct off site reviews in between surveillance visits by any one of the following: requesting information from the Client or checking of their web sites or visits to the Clients customers.
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Surveillance Audits. After a Certificate has been issued, TÜV conducts periodic Surveillance Audits to verify the ongoing effectiveness of the Applicant’s management system. At a minimum, these Surveillance Audits shall be carried out on six monthly or in few cases an annual basis. The first surveillance audit shall be conducted within 6 months from certificate issue date. As per the requirements of accreditation and/ or certification body, the surveillance audit could be un-announced. Applicant shall participate and provide adequate access during un-announced audits.
Sample 1

Related to Surveillance Audits

  • Surveillance The COR will receive and document all complaints from Government personnel regarding the services provided. If appropriate, the COR will send the complaints to the Contractor for corrective action.

  • Video Surveillance All video surveillance will be directed by the YSU police department.

  • Reviews (a) During the term of this Agreement and for 7 years after the term of this Agreement, the HSP agrees that the Funder or its authorized representatives may conduct a Review of the HSP to confirm the HSP’s fulfillment of its obligations under this Agreement. For these purposes the Funder or its authorized representatives may, upon 24 hours’ Notice to the HSP and during normal business hours enter the HSP’s premises to: inspect and copy any financial records, invoices and other finance- related documents, other than personal health information as defined in the Enabling Legislation, in the possession or under the control of the HSP which relate to the Funding or otherwise to the Services; and inspect and copy non-financial records, other than personal health information as defined in the Enabling Legislation, in the possession or under the control of the HSP which relate to the Funding, the Services or otherwise to the performance of the HSP under this Agreement. (b) The cost of any Review will be borne by the HSP if the Review: (1) was made necessary because the HSP did not comply with a requirement under the Enabling Legislation or this Agreement; or (2) indicates that the HSP has not fulfilled its obligations under this Agreement, including its obligations under Applicable Law and Applicable Policy. (c) To assist in respect of the rights set out in (a) above, the HSP shall disclose any information requested by the Funder or its authorized representatives and shall do so in a form requested by the Funder or its authorized representatives. (d) The HSP may not commence a proceeding for damages or otherwise against any person with respect to any act done or omitted to be done, any conclusion reached or report submitted that is done in good faith in respect of a Review.

  • Regulatory Affairs From the point in time at which Novartis gives GW notice in writing that it wishes to take on responsibility for Regulatory Filings and Regulatory Approvals in the Territory, Novartis shall be responsible for all interactions with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory. (a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such scheduling. (b) Subject to Section 6.1(g), Novartis (or its applicable Affiliate or Sublicensee) will file and hold all Regulatory Approvals for the Products in countries in the Territory in its own name and on its own behalf. Unless otherwise agreed by the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid by GW to Regulatory Authorities in such countries with respect to the submission of such Regulatory Filings. On request by Novartis, GW will deliver notices of such assignment to the applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing. (c) Subject to Sections 4.2 and 6.1(e), Novartis (or its applicable Affiliate or Sublicensee) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretion; provided, however, that Novartis agrees to submit Regulatory Filings for Marketing Approvals for a Product in each of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar Quarter. (d) Novartis will: (A) determine the regulatory plans and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings with respect to the Products in the Territory; and (C) will be responsible for obtaining and maintaining Regulatory Approvals with respect to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly: (i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory; (ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority; (iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term. (e) GW shall, without additional consideration, fully cooperate with and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: (i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; (iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product; (v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoice. (h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. (i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.

  • Monitoring In each case in which the Foreign Custody Manager maintains Foreign Assets with an Eligible Foreign Custodian selected by the Foreign Custody Manager, the Foreign Custody Manager shall establish a system to monitor (i) the appropriateness of maintaining the Foreign Assets with such Eligible Foreign Custodian and (ii) the contract governing the custody arrangements established by the Foreign Custody Manager with the Eligible Foreign Custodian. In the event the Foreign Custody Manager determines that the custody arrangements with an Eligible Foreign Custodian it has selected are no longer appropriate, the Foreign Custody Manager shall notify the Board in accordance with Section 3.2.5 hereunder.

  • Compliance Audits D. 4.1 Compliance Audit(s). Without limiting the generality of section A.7.4 (Records Review), if requested by the Province from time to time, which request shall be at the Province’s sole discretion, the Recipient, at its own expense, will forthwith retain an independent third party auditor to conduct one or more compliance audits of the Recipient or any Project. The audit will be conducted in accordance with Canadian Generally Accepted Auditing Standards, as adopted by the Canadian Institute of Chartered Accountants, applicable as of the date on which a record is kept or required to be kept under such standards. In addition, the audit will assess the Recipient’s compliance with the terms of the Agreement and will address, with respect to each Project, without limitation, the following: (a) whether the Funds were spent in accordance with the Agreement and with due regard to economy, efficiency, and effectiveness; (b) the Project’s progress or state of completion; (c) whether the financial information the Recipient provided is complete, accurate, and timely, and in accordance with the Agreement; (d) whether the Recipient’s information and monitoring processes and systems are adequate to identify, capture, validate, and monitor the achievement of intended benefits of the Project; (e) the overall management and administration of the Project; (f) recommendations for improvement or redress; and (g) whether prompt and timely corrective action is taken on prior audit findings.

  • Regulatory Examinations The Sub-Advisor will cooperate promptly and fully with the Advisor and/or the Trust in responding to any regulatory or compliance examinations or inspections (including information requests) relating to the Trust, the Fund or the Advisor brought by any governmental or regulatory authorities having appropriate jurisdiction (including, but not limited to, the SEC).

  • Audits No more than once a year, or following unauthorized access, upon receipt of a written request from the LEA with at least ten (10) business days’ notice and upon the execution of an appropriate confidentiality agreement, the Provider will allow the LEA to audit the security and privacy measures that are in place to ensure protection of Student Data or any portion thereof as it pertains to the delivery of services to the LEA . The Provider will cooperate reasonably with the LEA and any local, state, or federal agency with oversight authority or jurisdiction in connection with any audit or investigation of the Provider and/or delivery of Services to students and/or LEA, and shall provide reasonable access to the Provider’s facilities, staff, agents and XXX’s Student Data and all records pertaining to the Provider, LEA and delivery of Services to the LEA. Failure to reasonably cooperate shall be deemed a material breach of the DPA.

  • Contract Audits Eligible Purchaser represents and warrants that it shall cooperate with Enterprise Services, the Office of the State Auditor, federal officials, and/or any third party authorized by law or contract, in any audit conducted by such party pertaining to any Contracts that Eligible Purchaser has made purchases from pursuant to this Agreement, including providing records related to any purchases from such Contracts.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

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