Testing audit report

Audit Report. A report of an independent audit of the computer validation process by an internal auditor (i.e. Quality Assurance) should be included with the summary report to management. The audit should compare the SOP and the initial parts of the protocol (what the system should do) with the test plan results (what the system actually does) and the summary report conclusions. 

Implementation Unit Test Documentation Report Code and Code Review Documentation In-process Vendor/System Developer Audit Report Integration Test Procedures ... 

Vendor documentation Vendor audit reports Engineering peer reviews Module testing Protocols Protocol reports... 

Howard Garston-Smith, formerly of Pfizer, has published a book on software quality assurance. It provides a postal audit checklist reproduced in Appendix 7C. If the supplier has already prepared an internal ISO 9000 mapping or an internal audit report on how it aligns to industry standards such as the GAMP Guide, this can be offered as an alternative to the auditor s postal checklist. A reduced postal checklist may be agreed upon, at the very least. Wherever possible, photocopies of actual example documents and test records should be inspected for documentary evidence of validation. Remember that the pharmaceutical and healthcare companies are themselves being inspected for documentary evidence of validation. 

Standard operating procedures represent evidence of management control. Inventories, test results, raw material assays, shipping codes, and internal audit reports all represent evidence of planning, follow through, and compliance. 

QC sample analysis program and results, instrument testing and maintenance records, results of performance demonstration projects, results of data assessment, audit reports, and record retention policies. 

The attribute assessment determines whether the container materials meet the specifications. A risk assessment should be performed to determine what level of quality assessment needs to be undertaken. This risk assessment should take into consideration the level of quality assessment performed by the manufacturer or supplier. For example, if the manufacturer has a limited quality assessment system, then the purchaser may be required to carry out an extensive number of checks. An audit of the manufacturer is the best way to determine what level of assessment needs to be undertaken by the purchaser. An audit may be part of certification or accreditation of the manufactiuer or the supplier. Audit findings can provide a list of so-called reliable suppliers (see also Sect. 21.5.1). The level of quality control imdertaken by a container manufactiuer can be obtained from one of these audit reports. When using an established approved supplier, a purchaser could reduce the amount of testing that needs to be undertaken. For example the level of testing could be reduced to an identity test and assessment of the supplier s certificate of conformity. A limited identity test could include dimensions, colour and text. Additional tests for parenteral product containers could include ... 

McCormick, T. and Keller, R.W. (February 5, 1992). Raw Material Test Audit Program forNBR Polymers (R D Test Report 979). Lebanon, TN Wynn s-Precision, Inc. 

Output documents data (Element 4.16) Reports, records, results of operations, tests, reviews, audits, etc. 

The records required for field residue study authentication are the same records that would be required to reconstruct the study. Although this total volume of information is a necessary part of the GLP study record, the field summary report is a small fraction of that record. The field summary report is simply the information the EPA reviewers wish to see as they consider the data and determine how well they represent the crop situation for which the pesticide tolerance is being requested. At the current time, the field summary report should contain the information requested on pp. 48 and 49 of OPPTS 860.1500. The summary report for each test site in a study will typically form an appendix in the final study report. This information must be accurately extracted from the raw data notebook or field record and must be audited by... 

QA SQPs should specify the amount of data to be audited and how the data points are chosen for audit. An auditor may choose to perform more thorough and more frequent audits on a recently validated system. The validation report can be used to assist in determining what and how much to audit. For example, if data summary printouts from the chromatographic computer system are used in the report, the validation report should be reviewed to verify that this summary function was tested during validation. If this portion of the computer software was successfully validated, verifying a few values from each table in the report may be sufficient. 

Vertical audits on random samples (i.e. checks made on a sample, examining all procedures associated with its testing from receipt through to the issue of a report) have not identified any problems. 

The gravitational field affects olfaction as it does vision, audition, or vestibular function. It could impair detection of dangerous fumes or burning electrical equipment in airplanes or space vehicles. Astronauts also report altered perception of food flavors under weightless conditions. Men and women tested with four scratch-and-sniff odor samples of the University of Pennsylvania Smell Identification Test identified odors more poorly when in an upside-down position (Mester eta/., 1988). 

It also comprises reporting and internal market (= mutual acceptance of data) requirements. The directive requires that the OECD Revised Guides for Comphance Monitoring Procedures for GLP and the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits must be followed during laboratory inspections and study audits. 

The FDA requires the name and address of the testing facihty to appear in the report so that when the report is submitted in support of a research or marketing permit the laboratory can be added to FDA s inventory of laboratories that are scheduled for GLP inspection. The name and address may also be used by FDA to estabhsh the site for any directed audit of the report. 

Could regulators conduct their own audits, not depending upon validation by laboratories In theory that strategy could be successful, but two problems stand in the way. First, resources, including time and expertise, permit only a very cursory spot check on compliance. Those limited resources are much better spent in reviewing comprehensive validation reports than in conducting very limited tests of system performance and compliance. 

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