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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.
- Damaged reputation
Using document creation 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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