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- Lack of Compliance
Features
- Security:
Files are stored on local hard drives or network
servers, and may be easily accessible to
unauthorized
individuals.
- Audit
Trail:
There are no audit trail of changes made to the
file,
even when made by authorized personnel.
-
eSignatures:
There is no provision of electronic signatures.
- Version Control: There is no provision
to create a controlled version
for each modification made to the file.
- FDA Inspections,
483's and Warning Letters
GxP (GLP, GMP, GCP) records
generated by spreadsheet calculations are
electronic records and should comply with
FDAs 21 CFR Parts 11/58. For critical
records 21 CFR Part 11 controls should be implemented. Most
critical are data integrity, data accuracy,
audit trails and electronic signatures.
Currently there are no specific FDA guidelines
on using spreadsheets in regulated environments.
On the other hand spreadsheet applications have
been audited as part of FDA inspections and many
warning letters have been issued.. While the original
inspection resulted in several observations and
a warning letter, the findings from the follow
up have been accepted and can be considered as
good practices for using spreadsheets in FDA
regulated environments.
- Damaged reputation
Using spreadsheet applications that are not
completely validated, in a non-compliant mode can damage your
company's reputation and even delay FDA's
approval process.
- Productivity
Loss
Legal costs and fines, damaged reputation issues all
negatively affect your efficiency and the
efficiency of your employees.
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