So how are health authorities reacting and responding to data integrity issues?

Breaches of That All-Important Trust

Health authorities regard data integrity problems as breaches of that all-important trust that we discussed earlier.

When health authorities no longer trust the company where these issues exist, it is often difficult for a company to overcome these types of observations and citations.

It’s important to remember there are numerous undesirable outcomes that might occur due to data integrity issues.

Catastrophic to a Company’s Reputation

As previously discussed, these consequences can be catastrophic to a company’s reputation and commercial success.

In addition to company impacts, intentionally falsifying data could be grounds for immediate dismissal of the colleague(s) involved from the company.

Product Recall

Product recalls and/or market withdrawals can create shortages and reduce patient access, as well as have a serious financial impact on the company.

It is common for health authorities to execute enforcement actions such as

• FDA 483s
• Notices of Concern
• Statements of non-compliance with GMPs
• Warning letters
• Import alerts
• Injunctions
• Seizures and denial of applications/holds on approvals

All of these outcomes have a negative impact on the customer or patients, the company, and possibly the individual employee.