Overview

The FDA and other regulatory bodies require spreadsheets to be validated and compliant with 21 CFR 11. Ofni Systems incorporates the latest validation techniques from GAMP 5 to thoroughly and comprehensively validate your spreadsheets. This brief tutorial will explain how we approach Excel spreadsheet validation, from preparing a spreadsheet through validation and testing.

Spreadsheet Preparation

The first step in the validation process is to identify key system requirements for your program. This includes identifying and assessing critical workflows. Spreadsheets are analyzed and VBA macros are evaluated. The relative risk of each requirement is reviewed and a proportionate quantity of testing is determined. These requirements will be used to develop user requirements specification (URS), functional requirements specifications (FRS or FS) or software design specifications (SDS or DS) depending on your company requirements.

	Note: For information about using automation to analyze and document spreadsheets for validation projects, click here.

Excel compliance with 21 CFR 11

A key system requirement is compliance with 21 CFR Part 11. If your Excel spreadsheet does not already have the technological tools to be compliant with 21 CFR Part 11, we recommend ExcelSafe, which provides MS Excel with audit trails, limited system access, password controls and other technological tools.

Testing and Qualification Protocols


Once requirements have been outlined and documented, the software is tested. Our validation professionals will document test plans and testing protocols, designed to demonstrate that your system meets all of your business requirements and regulatory requirements outlined by 21 CFR Part 11. As appropriate, this includes testing plans, installation qualifications (IQ), operational qualifications (OQ) and performance qualifications (PQ). Deviations, if they exist, will be reported and resolved.

Benefits of validating your MS Excel Spreadsheet


Validating your Excel spreadsheet means all data can be used to make quality and GxP decisions or submitted to regulatory organizations like the FDA. Unlike some spreadsheet validations which require reliance on paper records, Ofni Systems' methods validates the Excel file, which allows you to query your data and create excellent data tracking and trending tools. You also have increased control over the data and who has access to information stored on your spreadsheets.

Benefits of Using Ofni Systems


Ofni Systems will quickly and efficiently assist you with all of your validation needs. Our validation professionals have the experience in helping large corporations and small companies meet their compliance requirements. Our validation professionals use FastVal to produce higher quality documentation identical to existing company documentation more rapidly than with a word processor alone. Let Ofni Systems' experience with validating MS Excel spreadsheets make validation simple for you.

Key Benefits of Using Ofni Systems Validation