Excel Spreadsheet Validation for Calculating Data coming from our Instruments (LIMS)

As an analytical lab offering a wide range of services for pharmaceutical, environmental etc. We use Excel spreadsheets for calculating data coming from our instruments (LIMS) and going into final reports. Can anyone point me in the right direction on information on how to validate these spread sheets (possibly a training session)? We already have a procedure to verify them for use but that is not sufficient for our auditors. We have many spreadsheets and our customers are requiring validation for both GMP work and non-GMP work.

Re: Excel Spreadsheet Validation for Calculating Data coming from our Instruments (LI

You asked for some directions, so here are some:
You are validating a software application and not EXCEL for FDA, GMP.
validating LIMS overview presentation @
http://www.gittel.info/Pubs/EuroLIMS2005.pdf
LIMS Validation packages @
http://www.arbourgroup.com/module.aspx?p1d=22
Validation points typical requirements specify the following:

• All inputs the system will receive such as sample collection data
• All outputs the system will produce such as reports
• All functions the system will perform such as calculations and trend analysis
• All performance requirements that the system will meet (data throughput, reliability, timing, etc.)
• The definition of all internal, external and user interfaces (instruments, other
  software)
• What constitutes errors and how errors should be handled
  The internal operating environment for the software (hardware platform, operating
  system, etc.)
• All ranges, limits, defaults and specific values the software will accept

Referenced @
http://www.atlab.com/index.php/Required-Steps-for-the-Validation-of-a-Laboratory-Information-Management-System.html
LIMS annual re-certification validation @
http://www.labhq.co.uk/rental-lims/labhq-lims-validation-support-package/

I hope this gets you closer to an answer

Re: Excel Spreadsheet Validation for Calculating Data coming from our Instruments (LI

Thanks George. That's a start, but what ablut Excel spreadsheets. We still use these for data calculations after we get the data from the instument, outside of the LIMS system. Is there a way to validate an excel spreadsheet, or several spreadsheets, as we have several that are used to perform secondary calculations.

Thanks for any help.

Re: Excel Spreadsheet Validation for Calculating Data coming from our Instruments (LI

EXCEL is a small application, (a pile of Marcos), and has INPUTS and OUTPUTS.
SRS, (software requirements specifications), @
http://www.cs.toronto.edu/~sme/CSC2106S/slides/08-Spec-and-Valid.pdf
The EXCEL spreadsheet is software, and you could develop a spreadsheet SRS spec.(being what it does: inputs/outputs etc.), and validate the specific spreadsheet.
Viewpoint resolution to the validation process @
http://www-di.inf.puc-rio.br/~julio/Slct-pub/ieee-tse.pdf
I would gather that the requirements might be somewhere described at the FDA or other.
General principles of validation @
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf
I have not gathered the specific requirement, but they are listed here within.
Microsoft has support @
http://support.microsoft.com/kb/211485
with a summer example:

Data validation is a feature available in Microsoft Excel. It allows you to do the following:

• Make a list of the entries that restricts the values allowed in a cell.
• Create a prompt message explaining the kind of data allowed in a cell.
• Create messages that appear when incorrect data has been entered.
• Check for incorrect entries by using the Auditing toolbar.
• Set a range of numeric values that can be entered in a cell.
• Determine if an entry is valid based on calculation in another cell.

Microsoft again @
http://office.microsoft.com/en-us/excel-help/apply-data-validation-to-cells-HP010072600.aspx
for another source, EXCEL data validation @
http://www.contextures.com/xldataval01.html
It all leads to doing the foot work or paying for shortcuts.