Results documentation verification

Software verification consists of tasks performed to evaluate if the software is performing desired tasks and providing desirable results. Software verification is part of software validation. Software testing is one of the many verification activities intended to confirm that software development output meets its input requirements. Other verification activities include various static and dynamic analyses, code and document inspections, walkthroughs, and other techniques [14]. 

The results of verification, evaluation, and tests are recorded and documented to provide evidence of conformance of the actual design to the planned design. This allows for comparison of the design input against the design output. 

Should you not use measuring devices in your organization, these requirements will not apply. If your means of verification are limited to visual inspection or professional judgement, as is the case with organizations that deal only with documentation, you will have no devices to control. However, you may use tools or computer software to assist you to determine conformance and these will need to be proven capable of producing a reliable result. 

Assessment results reflect the method selected. Any assessment you conduct will involve sampling of documentation and interviews with the people involved in program development and implementation. The scope and depth of your fact-finding and verification efforts will determine how detailed an Implementation plan can be developed. 

Any validation and verification work performed must always be documented in such a way that the results can be checked and the scope of a method is clear. International standards, e.g., ISO 17025, contain separate sections regarding documentation, which should be observed. The NMKL procedure on method validation states that It is of particular importance that the report includes all raw data from the experimental work, or references to where such data can be found . In some circumstances this complete documentation is impractical. Even where it is practical, it is usually impossible to publish these results together with the methods. 

Tests or verification documents—specifications of correct behavior, concrete initialization and test data, expected results, and actual results. 

They provide verification that all action items resulting from recommendations have been resolved to completion, are documented, and are effective. 

The GLP standards state that all raw data, documentation, records, protocols, specimens, and final reports generated as a result of a study shall be retained. Specimens do not need to be retained after QA verification. Storage conditions must allow for expedient retrieval with an indexing system. Access to the archived records must be limited to authorized personnel. 

Alert levels. Every time an alert level is reached, the Manufacturing and Quality Assurance managers are notified. Verification of the satisfactory operation of all components of the environmental control system, including but not limited to HVAC systems, equipment operation procedures, and material handling procedures is performed. The results of the investigation and any actions taken are documented. 

OQ tests are very commonly used in the ongoing performance verification or calibration of the system. Test templates should be used for OQ. An example is shown in Figure 17.2. Most important is that acceptance criteria should be defined before the test, and both acceptance criteria and test results should be documented in the test sheet. 

The standardization of this type of measurement in ISO TC 45 came to a grinding halt as a result of problems with ASTM copyright, possible patent issues, lack of verification of the applicability of the standard test conditions and the need to make the document applicable to instruments from different manufacturers. It looks like a prime case of where a standard should be written in the form of a guide because the procedure and test conditions will vary according to the particular production situation and problems. 

To control the manufacturing procedure adequately and to confirm the specifications of the in-process product or the final product, the manufacturing machines and measurement equipment shall be maintained to work accurately and consistently. Since accurate inspection ensures the results of test items measured by the intended equipment, the method for inspection shall always be carried out in the same manner. To ensure consistent inspection, the documented procedure shall be maintained, both with accurate inspection records and verification of the records. (See Table 4.)... 

During qualification testing there may be instances in which the acceptance criteria for a particular qualification verification or test is not met. This must be identified (usually as a deviation) and the corrective action recorded, complete with plans for any retesting that may be required. The implementation of any resulting corrective action must be formally documented and test reruns approved and allocated a new test run number. 

Operational verification of packaging components. A simulated production run is used to observe, assess, and document the performance of the equipment with packaging components. The behavior of the components on the equipment should be in accordance with the SOPs. Any discrepancies between the intended/planned and actual operation are corrected. After the corrections have been made, a simulated production run and the tests procedures are repeated and the results are documented. 

For computer workstations, the workstation configuration must be verified using the technical design specification. The result of the verification must be documented using the data collection forms located in the approved protocol. 

Once the hardware installation qualification protocol has been completed, the test results, data and documentation are formally evaluated. The written evaluation should be presented clearly and in a manner that can be readily understood. The structure of the report can parallel the structure of the associated protocol. The report should also address any nonconformances encountered during the hardware installation qualification, and their resolution. The hardware installation qualification report summarizes the results of the verification and testing of all hardware technologies that are part of the system. 

Upon successful installation of the software, a printout of the resulting directory listings may be obtained for verification and documentation purposes. This printout may be enclosed as part of the executed software IQ protocol. 

All installation qualification activities and resulting data must be verified by a second (independent) person. Evidence of verification activities may be confirmed by signing of the corresponding data collection form verification activities must include the date on which the activity was performed. The reviewer s signature indicates that the test was completed as expected, that the acceptance criteria were met, and that the appropriate documentation/ evidence (if applicable) was collected. 

The laboratory should verify and document the proper functioning of the software immediately after any new data acquisition or management systems have been installed. The baseline verification consists of manual calculations to confirm the correctness of all computer calculations. Ongoing verification takes place during laboratory data review process whenever a reviewer replicates one of the results generated by the computer or a manual calculation from a bench sheet. All information used in the calculations (raw data, calibration data, laboratory QC checks, and blank results) is kept on file for the reconstruction of the final result at a later date, should it become necessary. Bench sheets that document sample preparation are also kept on file for the same purpose. 

Pre-established, systematic written procedures for organization and conduct of trials, data collection, documentation and statistical verification of trial results. Approval by relevant ethics committees and by relevant health authorities. 

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