Pharmaceutical companies are constantly under pressure to get products to market faster – but not at the expense of quality or compliance. Traditional Quality Control workflows, with their heavy manual components (reviewing labels, packaging, proofreading, inspections), often create bottlenecks. In this post, we’ll explore how automating QC transforms workflows, drives speed, reduces errors, and helps pharma teams stay regulatory-safe (without slowing down launch timelines).
1. The Challenge of Manual Quality Control
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Time delays: Manual reviews, repeated proofreading, and human QC checks can take days or even weeks, especially when revisions or corrections are needed.
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Inconsistency & error risk: Human fatigue, misinterpretation of guidelines, or simple oversight can cause mistakes such as label misprints, incorrect braille, or packaging misalignments.
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Scalability issues: As pharma product portfolios grow, or new regulations/language/localization needs arise, manual QC effort multiplies without proportional resources.
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Regulatory risk: Errors caught late may lead to non-compliance notices, recalls, reprinting costs, or delayed approvals.
2. What Is Quality Control Automation?
Quality Control Automation refers to the use of software and digital tools – such as AI OCR, XML input, automated proofreading, barcode and braille checks, and compliance verification – to replace or streamline manual QC tasks.
In pharma, this includes:
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Automated proofreading of text content.
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Packaging layout validation.
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Barcode & braille verification.
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Version control and automatic comparison of text changes.
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Automated audit trails for regulatory compliance.
Unlike generic automation tools, pharma-tailored solutions meet stricter requirements for traceability, multiple languages, and integration into validated GMP workflows.
3. Benefits of Quality Control Automation in Pharma
Faster time to market:
Automation significantly accelerates workflows. For example, digitized and automated QC labs have reduced lead times by up to 60–70%.
Reduced deviations & errors:
Automation and digitization can lead to a 65% reduction in overall deviations and 90% faster deviation closure times, according to McKinsey.
Increased productivity:
In more mature labs, digitization and automation have enabled 30–40% productivity increases even before full automation.
Better compliance & traceability:
Automated QC provides reliable audit trails, reduces manual transcription errors, and enhances data integrity – critical for FDA, EMA, and GMP compliance.
Cost savings & resource optimization:
Automation reduces costly reprints and recalls, while freeing skilled staff from repetitive tasks so they can focus on higher-value work.
4. Smarter Quality Control with InformaIT’s Automated Proofreading
Here’s how InformaIT’s solutions help pharma QC workflows speed up while improving quality:
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Automated Proofreading & Text Comparison: Catch errors in labels, disclaimers, fonts, braille, and barcodes instantly.
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AI OCR + XML Input: Accurately extract and validate text from complex or scanned inputs, with structured data built for regulatory needs.
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Compliance-Focused Checks: Built-in rules for pharma labeling and packaging ensure FDA/EMA alignment.
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Version Control & Audit Trails: Track every change – who made it, when, and why.
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Scalable Review Cycles: Faster iterations mean fewer delays in packaging sign-off and regulatory submission.
Scenario example: A pharma team using automated proofreading can cut days off their review cycles and reduce labeling errors, ultimately getting products to market faster.
Manual QC processes are increasingly a liability in today’s fast-paced pharma environment. Automation isn’t just about “doing QC faster” – it’s about doing it more accurately, more reliably, and with full regulatory confidence.
