Spreadsheet Validation
Spreadsheets offer a simple and convenient means of recording data and can also do some simple, or complex, calculations to save time and allow the user to determine whether results collected are acceptable. They are often used to record GxP data and then automatically execute calculations which may have a bearing on product release.
If you use spreadsheets in this manner then you must be able to show that the spreadsheet is functionally correct, and that the data held within the spreadsheet is protected. Spreadsheets fall into the FDA regulation 21 CFR Part 11 electronic records' category.
To comply with the FDA requirements you need to qualify the spreadsheet, and then put an audit trail around the spreadsheet to ensure that data is input correctly and not changed without appropriate authorisation(s).
ITS can help with this by validating the spreadsheet on your behalf. Once verified the spreadsheet can be protected by using ezGXP™, a 21 CFR Part 11 compliant software solution, designed to protect Microsoft™ Excel® against unauthorised access and security violations.
ITS provides a complete spreadsheet verification package covering the following:
- 1. Ensuring that spreadsheet functionality is adequately defined
- 2. Providing verification that the spreadsheet functions as defined with relevant data verification and protection
- 3. Following completion of the verification exercise, ITS also offers ezGXP™, a 21 CFR Part 11 compliant software solution, designed to protect Microsoft™ Excel® against unauthorised access and security violations. The program runs invisibly in the background without the need for additional resources. ezGXP™ provides compliance with electronic records, electronic signatures, audit trails, and record integrity requirements.
- The system has the following operational capabilities:
- Secure password management system
- Reliable and indestructible audit trail
- Secure and reliable software program administration process
- Electronic signatures capable of authenticating the review and approval of electronic records
- Prevents electronic records from being erased, changed, or illegally modified
- The software offers total compliance at minimal cost, minimal training and with rapid integration.
ITS is running a series of Free ezGXP Product Demonstration Webinars on the following dates:
Friday, 30th January 2009 at 10.30
Friday, 27th February 2009 at 10.30
Friday, 27th March 2009 at 10.30
Friday, 24th April 2009 at 10.30
Friday, 22nd May 2009 at 10.30
If you are interested in attending please book online.
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