CDER’s “tag along” inspections — announced in May — puts 21 CFR Part 11 enforcement back in the news. They could also put you in the news if your electronic systems fail to comply.
Sure, it’s hard to decipher what Part 11 actually requires. But misunderstandings don’t excuse you from enforcement. And now GMP, GLP and GCP inspection gives field officials a new opportunity to spot violations.
It’s time to nail down what the CDER expects.