Product Validation Clause Samples
The Product Validation clause establishes the requirement for verifying that a product meets specified standards or criteria before it is accepted or delivered. Typically, this involves testing, inspection, or review processes to ensure the product functions as intended and complies with contractual or regulatory requirements. By mandating such validation, the clause helps prevent the delivery of defective or non-conforming products, thereby reducing the risk of disputes and ensuring quality assurance for both parties.
Product Validation. Please provide a clear description of the quality assurance programmes in place for the manufacture of each of the proposed articles, and in particular, the steps taken to ensure that the assay cut-off values remain within the required tolerance. Quality assurance reports for the past 3 years should be provided. Suppliers are to produce evidence in support of assurance claimed for each testing product.
Product Validation. Upon receipt and installation of the new system, Customers should perform a basic test of all main functional areas within the confines of their specific environment that includes the facility’s trained personnel, specific hardware, and specific procedures. Validation experts contend that the extent to which a user tests application software should be based on the degree of risk associated with each function. To assist our customers in validating the software application, IDM has developed a document referred to as the Validation Tool. The Validation Tool includes a list of the risk-related functional areas designed within the software, and a series of suggested steps to test each of these defined areas. In addition, a series of workflow scenarios are provided to test the integration of the major functional areas found in the system. IDM support is available to assist with validation questions and concerns. These suggested test steps are not intended to be all-inclusive. Users are responsible for validating the software in accordance with their own Standard Operating Procedures (SOPs), in order to ensure that the software is operating as intended within their own environment. During this phase, IDM will work with customer personnel to determine a final, global configuration for full deployment.
Product Validation. RxElite shall pay in addition to the above, by wire transfer, all necessary costs for process validation batches necessary for the approval in each respective country , and this product will be sold under the profit share terms of this agreement, once approval has been finalized in each country. Additional development fees for further country filings shall be agreed upon by both parties and paid to Core Tech from RxElite as due for each country filing.
Product Validation. Bidders will be required to provide evidence in support of the levels of assurance claimed for each testing product. The best evidence comprises independent papers published in the scientific literature, related to specific testing products. Results should be given both for spiked oral fluid samples and for clinical samples. Bidders should also describe fully the quality assurance procedures in place for the manufacture of each of the proposed articles and in particular the steps taken to ensure that the assay cut-off values remain within the required tolerance. Quality assurance reports for the past three years manufacture of proposed articles should be submitted.
Product Validation. It is understood and agreed by the parties hereto that all processes affecting the purported identity, strength, or quality of the Product being manufactured, assembled and/or packaged shall be qualified and maintained in a validated state. ALCON shall be notified in advance of such validations and the protocols describing these validations shall be reviewed by ALCON’s Quality Assurance Department prior to the commencement of any validation and in accordance with Article I, Section 1.04. ALCON shall assess any intended product validation protocols based on the potential risk and will not unreasonably withhold or delay consent. Copies of validation reports and data will be made available to ALCON by the SELLER in the event such documentation is needed to support Product applications or dossiers.
Product Validation. Bidders will be required to provide evidence in support of the levels of assurance claimed for each testing product. The best evidence comprises independent papers published in the scientific literature, related to specific testing products. Results should be given both for spiked urine samples and for clinical samples. Bidders should also describe fully the quality assurance procedures in place for the manufacture of each of the proposed articles and in particular the steps taken to ensure that the assay cut-off values remain within the required tolerance. Quality assurance reports for the past three years manufacture of proposed articles should be submitted. NOMS RSG will conduct on-going independent quality assurance on a regular basis. The quality assurance process may identify aspects of product performance or procedures that would benefit from improvement. Where such improvements serve to bring procedures up to the level set out in this specification the provider will be required to make those improvements without additional cost to the Prison or NOMS. Product Origin For all testing products proposed there will be a clear and full statement of product composition, origin and manufacturer. This will include a statement for all the component parts (of the testing product) including the antibodies and will include the final assembly of the testing product. A clear statement must be given on copyright ownership of each component part and of final testing product. A clear statement should be given of any potential challenges to copyright or challenges to copyright pending.