Ask About Validation

Are you working in the Pharmaceutical, Biotechnology or Medical Devise Industry? Do you use Excel in your organisation to handle data that has a direct or indirect impact on your Quality System.

Whats a great solution! Askaboutvalidation.com made it so easy for us to bring our spreadsheets into a state of compliance before our FDA audit! Andy – Aspen Pharma

Spreadsheet Validation is a must!

Just because you have been using the spreadsheet for years does not mean that you are exempt from validating it, in fact an auditor might clamp even harder if no effort has been made to even bring the spreadsheet to a state of compliance. If you do work with spreadsheets, ask yourself the following two questions:

• Is your spreadsheet fully validated?
• Does the spreadsheet comply with 21 CFR Part 11?

Widely used

Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. They are considered software and should be validated when used in a regulated environment. Excel Complete offers:

• Simple and effective remediation of Excel Spreadsheets for 21 CFR Part 11
• Compliance
• Easy installation can be performed by end-users without IT assistance
• Document Applications on the Servers
• Reduced validation effort using available validation package

What is Excel Complete?

Excel Complete consists of ExcelSafe and ExcelVal

What is ExcelSafe?

ExcelSafe provides all of the following to your Excel spreadsheets:

Compliance with 21 CFR Part 11

ExcelSafe works with existing MS Excel spreadsheets. It does not change calculations, macros or VBA code. ExcelSafe provides the technological tools to comply with 21 CFR 11, including:

• Limiting System Access (21 CFR 11.10d)
• Program Time-Outs (21 CFR 11.10d)
• Audit Trails (21 CFR 11.10e)
• Authority Checks (21 CFR 11.10g)
• Electronic Signatures (21 CFR 11, Subpart B)

Spreadsheet Security

• Determine which users can view or edit spreadsheets
• Prevent unauthorized access to spreadsheets
• Prevent unauthorized changes to spreadsheet data
• Customize security level settings for individual spreadsheets

What is ExcelVal?

ExcelVal is the master validation protocol we supply with ExcelSafe which allows you to fully document how each spreadsheet you use in your organization is validated. ExcelVal works in tandem with ExcelSafe.

Theres no point in having the technology in place unless you can prove to an auditor that the spreadsheet is actually validated and if there is a change to the spreadsheet, then you have a mechanism to track each change, thus keeping your spreadsheet in a state of full compliance

Questions & Answers:

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Cost:

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