Technical Validation Clause Samples

Technical Validation. An approval issued by the VA following a review of technical documents which is more in depth than a review for a streamlined validation. - This applies to all design approvals not eligible for Acceptance or Streamlined Validation.

Technical Validation. The overall architecture is validated trough the validation of the workflows and the integration of its components. Each technical aspect is carefully checked and validated on a binary scale (a technical criteria is fulfilled or not). Below is the list of technical criteria to be checked, together with their respective information regarding their validation. Some of the criteria have been partially extracted from the document [WP8, D8-1](User Requirements)/2.3/2.4.

Technical Validation. Before using the novel measurement in pauents, a robust assessment of the usability, reli- ability and reproducibility of the technology and flow of data should be performed. Minimal technological standards The reliability and consistency of devices should be assessed in the form of inter- and intra-device variability. The flow of data should be automated, requiring as liчle manual input as possible in order to reduce data (entry) errors. The flow should be consistent and allow for the subjects’ privacy by design, for example via encrypted transmission of data23. Furthermore, the data flow must be part of the validauon and comply with the necessary Fda regulauons regarding audit trails and the storage and processing of source data11. In the case of technological gold standards that can be used as a reference, a head-to-head comparison should be conducted in a standardized seчing to determine the bias and limits of agreement, specificity and sensiuvity, depending on the type of measurement. Furthermore, an analysis should be conducted with non-pauent test subjects to ensure that a novel measurement truly captures the behavior, symptom, or acuvity it aчempts to quanufy in various real-life situauons. For example, a smartphone accelerometer is capable of counung steps taken per day, but some may leave their phones on a desk or in a locker, bag or jacket when going for a walk, which leads to low accelerometer counts with liчle informauon of the underlying reason. While it is not possible to simulate all situa- uons that might occur in daily life, a supervised test of limited durauon may result in the detecuon of easily addressable confounders. In this case, the exact clinical relevance will not yet be determined, and the test subject merely funcuons as a free-living data gener- ator in a closely observed seчing. In this phase of validauon, it is also advised to consider the amount of training and instrucuon that will be necessary to ensure measurements are conducted correctly by pauents. Not all these steps are feasible in all cases. For example, when there is no obvious tech- nical gold standard or when the measurement is a completely new concept, a head-to- head comparison is impossible. In this case, technical validauon is necessarily more limited and clinical validauon gains a larger role. Handling of discordance Technological validauon of novel measurements is vital for the validauon process, and if there is a near perfect agreement with an unchallenged t...

Technical Validation. For projects classified as Non-Basic, a Technical Validation may be performed by the VA to support issuance of the VA design approval. 3.5.7.1 The objective of the Technical Validation process is to provide the VA with sufficient information for it to identify the applicable Non-Basic criteria, and within the scope defined by those applicable criteria, establish its certification basis and acceptable means of compliance. 3.5.7.2 The VA may choose to limit the Technical Validation process to a review of the application, proceeding from there directly to request the CA Statement of Compliance, as noted in paragraph 3.5.9.1(f). Intermediate steps such as a work plan are not required in such cases. 3.5.7.3 Technical Validation can be performed as a sequential or as a concurrent validation. (a) In a sequential validation, the CA has completed its certification, or is well advanced in the certification process, before the applicant requests validation by the VA. In this case, the CA certification basis and acceptable methods of compliance (MoCs) have been established and may or may not have received final approval by the CA. Type design changes, revised operating limitations, or new or revised certification testing or analysis may be required in a sequential program to meet the requirements of the VA, since these requirements may not have been considered during the original CA certification. (b) In a concurrent validation, the applicant requests validation of the product by the VA at the same time as certification by the CA, with the objective to get the CA and the VA approval at the same, or nearly the same time. (1) This approach allows unique VA requirements to be addressed during the design development and initial compliance demonstration. (2) A concurrent validation provides an opportunity for collaborative development of both CA and VA use of exceptions to the latest airworthiness standards, Special Conditions, Exemptions, Deviations, Equivalent Level of Safety Findings and acceptable MoCs. Additionally, it provides for early identification of areas where jointly agreed solutions are not readily available. (3) A concurrent validation may use any or all of the following optional provisions: (i) Work Sharing A work sharing program may be used in areas where the VA may make compliance determinations on behalf of both the VA and CA. Work sharing may be advantageous when certification activity is occurring within the geographical area of the VA, or when limited...