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Accidental input of an inappropriate data type should be prevented or result in an error message.The Working Group of Information Technology (AGIT, Arbeitsgruppe Informationstechnologie) consists of representatives of the GLP Compliance Monitoring Units and of invited experts from the industry. Also in pharmaceutical companies, Excel Spreadsheets are used in different departments.The easy to use calculations allow making calculations in a very convenient way. In a pharmaceutical environment, computerized systems need to be validated.
However, controls are quite often inadequate and this may result in a compliance risk.Spreadsheet validation is an often neglected task and one that attracts the attention of all regulators, simply because they are pretty certain that they will find problems in the use, or design, or in the actual spreadsheet validation and or qualification.Erroneous calculations due to data remaining from previous calculations must be avoided.The templates should also be suitably checked for accuracy and reliability (annex 11 p7.1) and should be stored in a manner which ensures appropriate version control (chapter 4 p4.1).When it comes to spreadsheets, what should be validated?
A Q&A issued by EMA provides the following answer: "Validation according to paragraph 4 of annex 11 is required at least for spreadsheets that contain custom code (e.g. Formulas or other types of algorithm should be verified for correctness." Therefore, appropriate controls for templates of spreadsheets must be in place.