Quick Tip

We lost a record. Should we recreate it?

It’s not unusual for an audit or a routine record search to turn up an old record that has gone missing. In today’s era of electronic documentation it’s rarer than it used to be, but it still happens.

Employees need to know that if they discover a missing document, honesty is essential. The FDA recognizes that records go missing. Too many missing records, or missing records discovered during an inspection, will pose a problem. But finding out that a company has lost a record is not necessarily a GMP violation that will warrant any enforcement.

Employees should report the missing document to their supervisors and your company should have in place a process for handling this glitch. Your process should involve creating a letter describing what has gone missing and when it was discovered, your efforts to locate it (which should be thorough), the steps you took to repair any damage the missing record might cause and the review you conducted to assess why it happened. The letter should be placed in the file where the record belongs, along with any additional information you have about what the record contained.

Regulators don’t expect perfect companies, but they do expect companies to be honest and proactive about addressing mistakes. For more training on good documentation, check out our Good Documentation Practices e-learning program.