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. 13.2. Flextronics shall have in place and maintain environmental controls meeting the applicable process control requirements of ISO 13485:2003 and FDA Quality System Regulation (21CFR820.70(c)), and applicable sections of 00 XXX 000, and subpart C, Buildings and Facilities, for the production of the Product. 13.3. Flextronics shall inform Alimera a minimum of [****] in advance unless otherwise agreed, of any change that impacts Product specifications. This includes changes to approved suppliers for Materials that are part of any Product Specifications. Flextronics shall obtain written approval from Alimera for any changes prior to implementation of changes.
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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. 6.1.1. If the SRC Quality System is certified, SRC must provide Broncus with copy of certificates. 6.1.2. If the SRC Quality System is hot certified or registered, Broncus must evaluate the SRC Quality System per Broncus Assessment procedures. 6.2. SRC must grant access for inspection/audit of its facilities, its Quality System, and its production/inspection/test processes used for the production of Broncus product to Broncus, to Broncus’ Notified Body, and to other Regulatory Authorities/Organizations. Where appropriate and upon Broncus request, SRC must ensure that access for inspection/audit of its Sub-Contractors involved in the production of Broncus product is also granted. 6.3. Broncus may review SRC production methods and inspection/test procedures for Broncus product and specify for which, if any, Broncus approval is required. 6.4. SRC must inform Broncus in advance of any substantial changes to product specifications, product indications for use, product safety, product sterilization, materials, production processes, inspection procedures, and product labeling. SRC must obtain written approval from Broncus for such changes.
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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. 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 stored on the production floor 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.
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Production Controls. 4.5.1 Test Methods and Specifications [**] [**]
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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”).
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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. 6.1.1. If the SRC Quality System is certified, SRC must provide Asthmatx with copy of certificates. 6.1.2. If the SRC Quality System is not certified or registered, Asthmatx must evaluate the SRC Quality System per Asthmatx Assessment procedures. 6.2. SRC must grant access for inspection/audit of its facilities, its Quality System, and its production/inspection/test processes used for the production of Asthmatx product to Asthmatx, to Asthmatx’s Notified Body, and to other Regulatory Authorities/Organizations. Where appropriate and upon Asthmatx request, SRC must use its best efforts to secure access for inspection/audit of its Sub-Contractors involved in the production of Asthmatx product. 6.3. Asthmatx may review SRC production methods and inspection/test procedures for Asthmatx product and specify for which, if any, Asthmatx approval is required. 6.4. SRC must inform Asthmatx in advance of any substantial changes to product specifications, product indications for use, product safety, product sterilization, materials, production processes, inspection procedures, and product labeling. SRC must obtain written approval from Asthmatx for such changes.
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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. 13.2 As defined by the validated process, the Product will be evaluated throughout production to ensure Specifications are met. 13.3 GERRESHEIMER will reconcile all Product components and all finished Product labels in accordance with its standard operating procedures. 13.4 All Defective Product must be quarantined and the deviation investigated appropriately per GERRESHEIMER standard procedures.
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Production Controls 
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Related to Production Controls

  • Access Controls The system providing access to PHI COUNTY discloses to 20 CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY 21 must use role based access controls for all user authentications, enforcing the principle of least privilege.

  • 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 a. System Security Review. CONTRACTOR must ensure audit control mechanisms that record and examine system activity are in place. All systems processing and/or storing PHI COUNTY discloses to CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY must have at least an annual system risk assessment/security review which provides assurance that administrative, physical, and technical controls are functioning effectively and providing adequate levels of protection. Reviews should include vulnerability scanning tools.

  • 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, DST shall provide Fund’s Chief Information Security Officer or his or her designee with a summary of its corporate information security policy and an opportunity to discuss DST’s information security measures, and a high level and non-confidential summary of any penetration testing related to the provision of in-scope services . DST 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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