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.