April 12, 2024

What are potential consequences of getting documentation practices wrong?

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Inadequate and poor documentation practices may result citations in the form of FDA’s 483 observation(s) and/or warning letters. Consequences of both may be time consuming and costly including time spent in responding to the observations and potentially making some operational changes.


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All missing entries must be explained. A line shall be drawn on all blank spaces to ensure that inappropriate entries are not made at a later date. If the blank space is left because an entry is not applicable, N/A must be entered. Backdating (entering a date on a day after the entry was made or the task was performed) is not permitted. Postdating (entering a date in the future) is not permitted. When a document requires an entry upon completion of an activity and the activity was performed but not documented, an explanation (by the performer of the activity) of why there was an omission must be included, signed, and dated.

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Inadequate and poor documentation practices may result citations in the form of FDA’s 483 observation(s) and/or warning letters. Consequences of both may be time consuming and costly including time spent in responding to the observations and potentially making some operational changes.

Imagine you have to retrieve legal documents from last year and are missing one key item. You search your office and computer and eventually find a copy in an old email account. Not only have you delayed your process, you’ve put your organization’s security at risk. Failing to protect your documents from the wrong hands violates compliance regulations and could put your board of directors and your organization in legal trouble. While poor document security is an evergreen problem, advances in software and new management practices can help you avoid critical failures.

Good Documentation Practices - ppt download

Compliance Issues

Compliance regulations outlined in the Sarbanes-Oxley Act and HIPAA (if you are in the health industry), require that sensitive information and documentation is secure and accessible. Even if you don’t suffer from a security breach, fail to follow proper regulations and track your information carefully may put you in a tricky situation.

Final Takeaway

It’s important that you have backups for all key documents. While multiple backups are an explicit feature of cloud storage systems, you will also want to have a backup method that you directly control. This could be a printed copy, a saved copy on a special hard drive, or a copy that you file in the form of an email. But remember that none of these methods are sufficient for the kind of accessibility and security that you need in a rapidly changing digital age. Putting in the initial effort of switching to a cloud-based system will protect you and transform your workflow.

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What are potential consequences of getting documentation practices wrong?
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What are potential consequences of getting documentation practices wrong?
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Inadequate and poor documentation practices may result citations in the form of FDA’s 483 observation(s) and/or warning letters. Consequences of both may be time consuming and costly including time spent in responding to the observations and potentially making some operational changes.
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