Expert Lists Data Integrity Red Flags for Drug Sponsors

Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at the RAPS’ 2017 Regulatory Convergence meeting.

Does the firm have a relatively current records retention schedule and policy? An outdated RRS and protocols will not function as they are intended to. “If you don’t know what you need to keep and for how long, you can’t control it,” he said.

Can senior management explain the relationship between good data integrity and product safety, efficacy and quality? Drugmakers cannot ensure quality data integrity without commitment from the top level of the company. “If you can’t explain it, you can’t lead it,” Avallanet said.

How often does the quality unit audit the data backups and long-term archives? Too many firms assume that conversion to PDF is the final step and no further action needs to be taken to assure data are not lost or otherwise degraded. “If you don’t ensure controls work throughout the data’s lifespan, you cannot have trustworthy data,” he said.