The integration of spreadsheet programs is frequently used by many FDA regulated industries, whether to speed up routine analytical analysis or to store data. It is difficult to control and manage spreadsheets, and more importantly, to ensure that they are fully validated per 21 CFR Part 11. PSC Biotech’s validation process will ensure that your spreadsheets comply with regulatory requirements.
Part 11 requirements should be considered and spreadsheets should be examined in order to determine which sections are applicable. If original input data is recorded in a laboratory notebook or worksheet, then the spreadsheet is used only to process calculations. Electronic records regulation is not mandatory if the spreadsheet is not saved electronically and all calculations are validated. However, spreadsheets that contain laboratory raw data files from instruments or used as part of a quality system must be regulated – saved and maintained to comply with 21 CFR Part 11, Electronic Records and Electronic Signatures. Risk analysis should be performed to establish the level of testing needed to ensure the integrity of the spreadsheets.
In partnership Ofni Systems, PSC provides a full range of services for spreadsheet validation and control to manage data access and ensure data integrity, reducing the risks of error and fraud.