Validating spreadsheets

Easy-to-create, surprisingly powerful and flexible, spreadsheets are so common they can almost seem invisible.

You can use spreadsheets in GMP, GCP, and GLP environments, but as with any computer system, the FDA expects measures to be in place to ensure system data are controlled and protected.

This includes password protection to ensure only authorized people can access your data, audit trails to track changes to system data, and user-level security to ensure that system users only perform actions they are authorized to do.

The report indicated that the results of a survey of twenty three professionals in this multi billion pound industry revealed some extraordinary and at times worrisome problems.The GAMP software category defines the of activities required to validate your spreadsheet. A good road map and some tips and tricks can help you on your way through the rough landscape of spreadsheet validation. However, we do have to make a remark: an Excel spreadsheet template is built upon the spreadsheet application Microsoft Excel.Which is principally not designed for regulated environments.Spreadsheets also need to comply with a number of requirements.However, controls are quite often inadequate and this may result in a compliance risk.Spreadsheet examples for Gx P related matters range from a simple template for calculations of impurity in a sample to a highly complex spreadsheet for statistical analysis of clinical studies including Visual Basic for Application macros.

You must have an account to comment. Please register or login here!