How will the blank form or spreadsheet be controlled?
The blank form or spreadsheet template must be maintained in a version-controlled environment to prevent unauthorized usage or modification. Additional securities may be required within the file structure to prevent editing or modification of key functions or formulas. Q: How will the completed form or spreadsheet data be used? A: Data integrity is a key risk for completed records. The records must be maintained according to a retention and document control policy, which prevents modifications to the documents that could obscure or destroy data. Audit history trails and version control methods can assist in achieving these issues. Additionally, companies need support systems to ensure that proper data backup and restoration functions can be conducted to ensure recovery of critical business data and quality records in the case of equipment malfunction or loss. Q: How will the form or spreadsheet data be distributed? A: The FDA requires that firms ensure that all electronic records are r
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