Excel Spreadsheet Validation for 21 CFR Part 11 Compliance

Choosing an approach that allows efficient validation.

This is the big question.

Everyone will have their own view on how to validate spreadsheets, and there are a variety of ways that can be successful. Some of the key points to remember are as follows.

First and foremost: You validate DaCS™ (or any other software tool) only once; but you have to validate each and every spreadsheet, and there may be 20 - 200 of them. Clearly the big savings to be made are in efficiency of validating the spreadsheets, not of the software tools.

In this diagram (PDF - 82KB), you follow the blue path once, and the red path as many times has you have spreadsheets

Use a proven process that works. If you don't, you risk doing all of the work, only to find it doesn't meet the validation standards you require, or that the process takes much longer than you first imagined.

Keep each spreadsheet as simple as possible to meet the user requirements. The more you add the more validation you need to do.

If possible avoid macros. Macros are custom code and as such have to be thoroughly validated. Only use macros to perform tasks that can not be done in other ways, e.g. don't use a macro to print or save when it's just as simple to select print or save from the File Menu.

Avoid software tools that add macros to each and every spreadsheet you have. No matter what the vendor argues, you are adding custom macros to every single spreadsheet, you would have to validate that macro every time, and verify that it doesn't interfere with your spreadsheets operation.

See how DaCS™ assists in this matter.

Have a generic documentation set, so that completing protocols for new spreadsheets is simply a case of "filling in the blanks" for much of the specification and protocol.

Use a team of experienced people: your goal is efficiency, so make the most of repeat learning.

To find out more: see, or download to view later, the Approach presentation from here.

Conclusion

Select a proven approach and keep spreadsheets as simple as possible. Avoid customisation. Use a generic document set and make the most of project experience. The ABB approach provides a complete and cost effective approach. Read the justification (PDF - 199KB) .




		Spreadsheet Validation Services

	Choosing an approach that allows efficient validation. This is the big question. Everyone will have their own view on how to validate spreadsheets, and there are a variety of ways that can be successful. Some of the key points to remember are as follows. First and foremost: You validate DaCS™ (or any other software tool) only once; but you have to validate each and every spreadsheet, and there may be 20 - 200 of them. Clearly the big savings to be made are in efficiency of validating the spreadsheets, not of the software tools. In this diagram (PDF - 82KB), you follow the blue path once, and the red path as many times has you have spreadsheets Use a proven process that works. If you don't, you risk doing all of the work, only to find it doesn't meet the validation standards you require, or that the process takes much longer than you first imagined. Keep each spreadsheet as simple as possible to meet the user requirements. The more you add the more validation you need to do. If possible avoid macros. Macros are custom code and as such have to be thoroughly validated. Only use macros to perform tasks that can not be done in other ways, e.g. don't use a macro to print or save when it's just as simple to select print or save from the File Menu. Avoid software tools that add macros to each and every spreadsheet you have. No matter what the vendor argues, you are adding custom macros to every single spreadsheet, you would have to validate that macro every time, and verify that it doesn't interfere with your spreadsheets operation. See how DaCS™ assists in this matter. Have a generic documentation set, so that completing protocols for new spreadsheets is simply a case of "filling in the blanks" for much of the specification and protocol. Use a team of experienced people: your goal is efficiency, so make the most of repeat learning. To find out more: see, or download to view later, the Approach presentation from here. Conclusion Select a proven approach and keep spreadsheets as simple as possible. Avoid customisation. Use a generic document set and make the most of project experience. The ABB approach provides a complete and cost effective approach. Read the justification (PDF - 199KB) .