How Electronic Batch Records Reduce QA Review Time from Hours to Minutes
6 hours to review a batch record. 5 hours and 45 minutes spent confirming nothing went wrong. For many cell and gene therapy (CGT) organizations, this is still the reality. Quality Assurance (QA) teams in GMP environments often spend 4-8+ hours reviewing a single paper batch record. Not because the process failed. But because the process requires manual verification of every signature, every calculation, every sequence, and every deviation. In FDA-regulated manufacturing, this level of diligence is essential. Patient safety, compliance, and product release timelines depend on it. The challenge is not the intent. It is the format. The Hidden …

