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.
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.
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.