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Nordtest Software Validation
Methods of System Validation (based on the Nordtest Software Validation)
The Nordtest method is the result of a Nordtest project performed by the Danish Institute of Fundamental Metrology where I was project manager. The two Nordic accreditation bodies, Norsk Akkreditering and SWEDAC and the two companies, Arepa Test & Kalibrering A/S in Denmark and Gambro Lundia AB in Sweden participated as partners in the project. The method originates from the Danish accreditation body DANAK's guideline RL10 "Use of computer systems in accredited laboratories" and is a tool to assist in the task of validating software. The method can be used by accredited laboratories and companies which need to validate software as well.
The method is approved by the Nordtest Expert Group as NT Techn Report 535 and may be downloaded free of charge from the Nordtest website http://www.nordicinnovation.net/article.cfm?id=1-834-741. The method contains a description part (PDF file), a report template (DOC file) and 4 examples (PDF files). All the Nordtest files can be downloaded from this site.
The template "Method of System Validation" is a variant of the "Method of Software Validation" and focuses on all parts of a computer system and not just on a software program. A number of validation options have been added and the term software product has been replaced with computer system.
The templates are second edition, 2. edition, February 2004 due to changes applied to the built-in macro in order to avoid run-time errors if an InlineShape object with invalid OLEFormat is inserted into the document by the user.
Note, due to the many ActiveX components in the document, it may take Word rather long time to open the report.
This tool contains two Word documents, System Validation Report Xp.DOC and System Validation Help.DOC, which are based on the template "Method of System Validation". All lines that contain an option (CheckBox marked with the symbol ¨ or þ), and all text-fields in the tables are provided with an unambiguous Word bookmark. This bookmark is used to identify option-lines and help-text in the on-line help document. Word must be able to use macros for this tool to work (select the medium security level as described below).
Change of the check-symbol and access to the on-line help document is provided via the ABC Toolbar, which automatically opens with the report.
On-line help will only work if Word can find the on-line help document and therefore it has to be saved either in the same folder as the validation report itself or in the folders used by Word to save documents and templates.
Since all ActiveX CheckBox components (except for one) are substituted by exchangeable symbols, Word will work considerably faster on this report. The ActiveX CheckBox component, which in the original System Validation Report could lock all other CheckBoxes, is improved and will now in addition provide write-protection of the entire document.
PDF Adobe Portable Document Format file Requires Adobe® Acrobat Reader - download from www.adobe.com DOC Word 2000 Document (used as template) Requires Microsoft® Office 2000 or XP ZIP Compressed file May require a WinZip® unpacking program (depends on the operative system)
The Word template documents contain ActiveX components and hereby also macros. The templates contain in addition a macro-module with a CheckBox function, which can lock (and unlock) all other CheckBoxes in the document and thus protect the final report against inadvertent changes.
In order to use the macro functions in Word they must be enabled. The default security level in Word is high implying that macros in the default settings cannot be used, and therefore the user has to lower the security level by himself. It is recommended to choose the medium security level because you on this level are asked if macros should be enabled. Never use macros in documents that originate from an unknown source or which is not expected to contain macros.