Production Controls Sample Clauses

Production Controls. 13.1. Flextronics shall have in place and maintain a quality system that meets the applicable requirements of ISO 13485:2003, FDA Quality System Regulations (21 CFR 820)for the production of the Product.
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Production Controls. 6.1. SRC must have in place and maintain a Quality System that meets the appropriate requirements of ISO 9001/2, EN46001/2, and EU MDD for the production of Broncus product.
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Production Controls. A process control plan (or similar document) shall be established and maintained that outlines the various production operations and the process controls necessary to manufacture acceptable product for GENMARK, if not already detailed and included in the process plan. The following is a list of items that must be considered for inclusion in the process control plan, dependent upon, and where appropriate for, the complexity of the process(es) used to manufacture product for GENMARK.
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Production Controls. 4.5.1 Test Methods and Specifications [**] [**]
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Production Controls. 13.1 It is the responsibility of GERRESHEIMER to adopt the necessary techniques and/or controls during all phases of manufacturing / packaging to control the quality of the Product. GERRESHEIMER shall maintain records of test performance sufficient to meet regulatory requirements. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Supplier Agreement Supplier Quality Agreement
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Production Controls. A process control plan (or similar document) shall be established and maintained that outlines the various production operations and the process controls necessary to manufacture acceptable product for Siemens, if not already detailed and included in the process plan. The following is a list of items that must be considered for inclusion in the process control plan, dependent upon, and where appropriate for, the complexity of the process(es) used to manufacture product for Siemens. 1. The controls to assure only accepted process inputs are used. Inputs are the materials and parts needed to make the product. 2. Clear identification (labeling) and separation of the materials and parts throughout all stages of the process in order to prevent mix ups and their unintended use. 3. Controls to prevent the use of materials that have exceeded or are nearing their expiration date. 4. The process to ensure the production line has been cleared of inputs from previous production runs for a different product (i.e., a “line clearance”). 5. The assignment of a unique lot or batch number, or date code, to the production run for future reference and record keeping. 6. The manufacturing steps required (i.e., the use of a route tag). 7. The criteria for workmanship, including representative samples. 8. The process characteristics (parameters) to be controlled during production. 9. The means, such as SPC, for the continuous monitoring and control of critical-control-points in the production processes. 10. The in-process product attributes that are critical to quality are monitored during production. 11. The defined acceptance and rejection criteria of the process output to ensure that they are correctly inspected/tested by qualified individuals. 12. Controls for the handling and reworking of in process nonconformances. 13. The final inspection and test methods to be used for product release. 14. Handling procedures to assure that personnel handling and moving both in-process and final product do not inadvertently cause nonconformances. 15. The procedure for adequately packaging the product for shipment to Siemens so that it is reasonable to expect that product quality will not be affected during transportation. 16. The method for recording process data and inspection/test results either electronically or on paper forms. D. Automated test systems. Software controlled and/or automated test systems used to determine the acceptance or rejection of incoming product, in-process prod...
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Production Controls. 6.1. SRC must have in place and maintain a Quality System that meets the appropriate requirements of ISO 13485 and the EU’s MDD for the production of Asthmatx product.
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Production Controls 
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Related to Production Controls

  • Access Controls a. Authorized Access - DST shall have controls that are designed to maintain the logical separation such that access to systems hosting Fund Data and/or being used to provide services to Fund will uniquely identify each individual requiring access, grant access only to authorized personnel based on the principle of least privileges, and prevent unauthorized access to Fund Data.

  • Technical Security Controls 35 a. Workstation/Laptop encryption. All workstations and laptops that store PHI COUNTY 36 discloses to CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of 37 COUNTY either directly or temporarily must be encrypted using a FIPS 140-2 certified algorithm which 1 is 128bit or higher, such as AES. The encryption solution must be full disk unless approved by the 2 COUNTY.

  • Agreement Controls In the event that any term of any of the Loan Documents other than this Agreement conflicts with any express term of this Agreement, the terms and provisions of this Agreement shall control to the extent of such conflict.

  • Plan Controls The terms contained in the Plan are incorporated into and made a part of this Agreement and this Agreement shall be governed by and construed in accordance with the Plan. In the event of any actual or alleged conflict between the provisions of the Plan and the provisions of this Agreement, the provisions of the Plan shall be controlling and determinative.

  • Audit Controls P. Contractor agrees to an annual system security review by the County to assure that systems processing and/or storing Medi-Cal PII are secure. This includes audits and keeping records for a period of at least three (3) years. A routine procedure for system review to catch unauthorized access to Medi-Cal PII shall be established by the Contractor.

  • TIA Controls If any provision of this Indenture limits, qualifies, or conflicts with another provision which is required to be included in this Indenture by the TIA, the required provision shall control.

  • Personal Controls a. Employee Training. All workforce members who assist in the performance of functions or activities on behalf of COUNTY in connection with Agreement, or access or disclose PHI COUNTY discloses to CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY, must complete information privacy and security training, at least annually, at CONTRACTOR’s expense. Each workforce member who receives information privacy and security training must sign a certification, indicating the member’s name and the date on which the training was completed. These certifications must be retained for a period of six (6) years following the termination of Agreement.

  • Accounting Controls The Company and its Subsidiaries maintain systems of “internal control over financial reporting” (as defined under Rules 13a-15 and 15d-15 under the Exchange Act Regulations) that comply with the requirements of the Exchange Act and have been designed by, or under the supervision of, their respective principal executive and principal financial officers, or persons performing similar functions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including, but not limited to, internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any material weaknesses in its internal controls. The Company’s auditors and the Audit Committee of the Board of Directors of the Company have been advised of: (i) all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are known to the Company’s management and that have adversely affected or are reasonably likely to adversely affect the Company’ ability to record, process, summarize and report financial information; and (ii) any fraud known to the Company’s management, whether or not material, that involves management or other employees who have a significant role in the Company’s internal controls over financial reporting.

  • Security Controls Annually, upon Fund’s reasonable request, Transfer Agent shall provide Fund’s Chief Information Security Officer or his or her designee with a copy of its corporate information security controls that form the basis for Transfer Agent’s Security Policy and an opportunity to discuss Transfer Agent’s information security measures, and a high level summary of any vulnerability testing conducted by Transfer Agent on its information security controls, with a qualified member of Transfer Agent’s information technology management team. Transfer Agent shall review its Security Policy annually.

  • Internal Controls The Company shall maintain a system of internal accounting controls sufficient to provide reasonable assurances that: (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary in order to permit preparation of financial statements in accordance with GAAP and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

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