PA/PH/OMCL (08) 87 R6 – Annex 1 of the OMCL Network Guideline “Validation of Computerised Systems”
Validation of Excel Spreadsheets
p.2/10
ANNEX 1 OF THE OMCL NETWORK GUIDELINE
“VALIDATION OF COMPUTERISED SYSTEMS”
VALIDATION OF EXCEL SPREADSHEETS
Note: Mandatory requirements in this guideline and its annexes are defined using the terms
«shall» or «must». The use of «should» indicates a recommendation. For these parts of the text
other appropriately justified approaches are acceptable. The term «can» indicates a possibility or
an example with non-binding character.
1. INTRODUCTION
This is the 1
st
Annex of the core document “Validation of Computerised Systems”, and it should be
used in combination with the latter when planning, performing and documenting the validation
process of Excel
®
spreadsheets used for the processing of laboratory data.
This Annex presents an example of Excel spreadsheet validation, which should be used in
combination with the general requirements and recommendations given in the core document.
2. INSTALLATION AND SECURITY
To guarantee that only the latest validated version of the spreadsheet is being used and to maintain
the validated state of the spreadsheet, all validated Excel spreadsheets should be stored with read-
only access rights for the end users (e.g., on a protected network share). Only responsible persons
should have write access to the network share.
End users should have no right to modify a validated spreadsheet, add a non-validated spreadsheet
to the share, or save data on the share. End users should only have the right to fill in the (permitted)
cells and to print the data or save a copy to a data repository if needed.
Installation shall be documented, e.g. in the validation file, in a system log book or on a QA form.
The name of the spreadsheet, unique identification, localisation, and the person responsible for the
spreadsheet shall be documented. The records shall also include verification, regular verification
and other issues such as updates or any problem encountered. Verification is completed after
installation and recorded.
3. GOOD PRACTICES
When setting up a new spreadsheet, following the good practices below will reduce the risk of
accidental modifications of the template and erroneous data input:
- All calculating cells shall be locked (Format Cells > Protection > Locked) in order to protect
cells containing calculations against unintended modification, except those used for data
input.