PROCESS CONTROLS Sample Clauses

PROCESS CONTROLS. 3.1 Both parties shall be responsible for all process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control, contamination control, complaint handling and trending and process validations, as required by Title 21 of United States Code of Federal Regulations, and other applicable regulations, and governmental laws.
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PROCESS CONTROLS. 2.1 Distributor shall be responsible for supplier appropriate process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control and facility contamination control.
PROCESS CONTROLS. 3.0.1 Will have the primary responsibility to FORMULATE and PACKAGE the PRODUCT in accordance with cGMPs, the master production records, PRODUCT SPECIFICATIONS, CMC DATA, and the NDA. X
PROCESS CONTROLS. The supplier shall maintain the following QMS controls:
PROCESS CONTROLS. Process monitoring and control operations will be performed by a computer based Control System. The Control System will coordinate CCC, boiler, pollution control, WTS, RRS and turbine generator and some auxiliary systems, all which be identified, defined and designed during the engineering phase. The Control System will be installed in either an administrative office or in the control room. Its major components will include necessary Input/Output Devices and an Operator Workstation. The Input/Output devices interface with required field input and output signals to provide data acquisition and stand along integrated control of the plant process. The Operator Workstation will provide an interface to the Control System for monitoring and controlling process operations. The operator Workstation will include a printer/logger and one operator console high resolution monitor, active graphic display, mouse and keyboard. The Control System will employ redundant processors and standby power supply to provide reliability and to minimize the effect of any single failure of the process control on process monitoring operations. These redundant devices shall be an integral part of the Control System. Upon detection of a failure in the primary device, the redundant device automatically will take over the required operation. If required, a separate centralized control panel will be provided for special instrumentation requirements and for specialized instrumentation whose function cannot be implemented in the computer based Control System. Fire/Explosion Suppression System Hose stations and automatic sprinklers will be installed for fire control and suppression. Additional hose stations will be located in the process equipment area, as required. Additionally, portable fire extinguishers will be located adjacent to each hose rack and in other areas as directed by local fire codes and safety practices and insurance requirements. Safety Safety procedures will be established by the plant manager and the chief engineer in accordance with industry standards. Together with design engineers, safety discussions and directives will provide the necessary guidelines for operating and maintenance personnel for specific equipment. Guidelines for plant safety standards and procedures will be based on labor and industry standards and the Federal Occupational Safety and Health Act (OSHA). Period safety meetings will be established and conducted by the plant manager and on-site engineering ...
PROCESS CONTROLS. 7.1 RTI shall maintain appropriate documented procedures.
PROCESS CONTROLS. Describe in general terms how the project development process will be controlled to achieve the objectives of the project. Identify controls used to ensure all work, services, and products meet project standards and requirements. Identify state-of-the-art equipment to be utilized. Project specific controls will be identified in the project specific quality control plan.
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PROCESS CONTROLS. 3.1 Both parties shall be responsible for all process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control, contamination control, [*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION. complaint handling and trending and process validations, as required by Title 21 of United States Code of Federal Regulations, and other applicable regulations, and governmental laws.

Related to PROCESS 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.

  • Loop Testing/Trouble Reporting 2.1.6.1 TeleConex will be responsible for testing and isolating troubles on the Loops. TeleConex must test and isolate trouble to the BellSouth portion of a designed/non-designed unbundled Loop (e.g., UVL-SL2, UCL-D, UVL-SL1, UCL-ND, etc.) before reporting repair to the UNE Customer Wholesale Interconnection Network Services (CWINS) Center. Upon request from BellSouth at the time of the trouble report, TeleConex will be required to provide the results of the TeleConex test which indicate a problem on the BellSouth provided Loop.

  • 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.

  • Access Control Supplier will maintain an appropriate access control policy that is designed to restrict access to Accenture Data and Supplier assets to authorized Personnel. Supplier will require that all accounts have complex passwords that contain letters, numbers, and special characters, be changed at least every 90 days, and have a minimum length of 8 characters.

  • 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.

  • System Access Control Data processing systems used to provide the Cloud Service must be prevented from being used without authorization. Measures: • Multiple authorization levels are used when granting access to sensitive systems, including those storing and processing Personal Data. Authorizations are managed via defined processes according to the SAP Security Policy • All personnel access SAP’s systems with a unique identifier (user ID). • SAP has procedures in place so that requested authorization changes are implemented only in accordance with the SAP Security Policy (for example, no rights are granted without authorization). In case personnel leaves the company, their access rights are revoked. • SAP has established a password policy that prohibits the sharing of passwords, governs responses to password disclosure, and requires passwords to be changed on a regular basis and default passwords to be altered. Personalized user IDs are assigned for authentication. All passwords must fulfill defined minimum requirements and are stored in encrypted form. In the case of domain passwords, the system forces a password change every six months in compliance with the requirements for complex passwords. Each computer has a password-protected screensaver. • The company network is protected from the public network by firewalls. • SAP uses up–to-date antivirus software at access points to the company network (for e-mail accounts), as well as on all file servers and all workstations. • Security patch management is implemented to provide regular and periodic deployment of relevant security updates. Full remote access to SAP’s corporate network and critical infrastructure is protected by strong authentication.

  • Disclosure Controls The Company and its subsidiaries maintain an effective system of “disclosure controls and procedures” (as defined in Rule 13a-15(e) of the Exchange Act) that complies with the requirements of the Exchange Act and that has been designed to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms, including controls and procedures designed to ensure that such information is accumulated and communicated to the Company’s management as appropriate to allow timely decisions regarding required disclosure. The Company and its subsidiaries have carried out evaluations of the effectiveness of their disclosure controls and procedures as required by Rule 13a-15 of the Exchange Act.

  • Xxxxxxxx-Xxxxx; Disclosure Controls The Company is in compliance in all material respects with all of the provisions of the Xxxxxxxx-Xxxxx Act of 2002 which are applicable to it. The Company maintains disclosure controls and procedures (as such term is defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act), and such disclosure controls and procedures are effective.

  • Disclosure Controls and Procedures; Deficiencies in or Changes to Internal Control Over Financial Reporting The Company has established and maintains disclosure controls and procedures (as defined in Rules 13a-15 and 15d-15 under the Exchange Act), which (i) are designed to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to the Company’s principal executive officer and its principal financial officer by others within those entities, particularly during the periods in which the periodic reports required under the Exchange Act are being prepared; (ii) have been evaluated by management of the Company for effectiveness as of the end of the Company’s most recent fiscal quarter; and (iii) are effective in all material respects to perform the functions for which they were established. Since the end of the Company’s most recent audited fiscal year, there have been no significant deficiencies or material weakness in the Company’s internal control over financial reporting (whether or not remediated) and no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company is not aware of any change in its internal control over financial reporting that has occurred during its most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

  • Internal Controls and Procedures The Company has established and maintains disclosure controls and procedures and internal control over financial reporting (as such terms are defined in paragraphs (e) and (f), respectively, of Rule 13a-15 under the Exchange Act) as required by Rule 13a-15 under the Exchange Act. The Company’s disclosure controls and procedures are reasonably designed to ensure that all material information required to be disclosed by the Company in the reports that it files or furnishes under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that all such material information is accumulated and communicated to the Company’s management as appropriate to allow timely decisions regarding required disclosure and to make the certifications required pursuant to Sections 302 and 906 of the Xxxxxxxx-Xxxxx Act of 2002 (the “Xxxxxxxx-Xxxxx Act”). The Company’s management has completed an assessment of the effectiveness of the Company’s internal controls over financial reporting in compliance with the requirements of Section 404 of the Xxxxxxxx-Xxxxx Act for the year ended December 31, 2010 and such assessment concluded that such controls were effective. Based on its most recent evaluation of internal controls over financial reporting prior to the date hereof, management of the Company has disclosed to the Company’s auditors and the audit committee of the Company Board (i) any significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting that are reasonably likely to adversely affect in any material respect the Company’s ability to report financial information and (ii) any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting, and each such deficiency, weakness and fraud so disclosed to auditors, if any, has been disclosed to Parent prior to the date hereof.

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