Why Digital QA and QC Are Worth It: A Technical Perspective

Perspective Quality departments in the pharmaceutical and biotech sectors face increasing pressure: stricter regulations, tighter timelines, and complex system landscapes. But how can digital tools in QA and QC actually deliver measurable value? This article provides a clear, data-driven view into the technical and operational challenges in quality assurance and control—and outlines how digitalization can significantly reduce documentation efforts, accelerate batch release, and increase overall efficiency.

Paul Planje

Chief Commercial Officer (CCO)

Quality Assurance (QA) and Quality Control (QC) are central processes in pharmaceutical manufacturing. Yet these areas often face persistent challenges: inefficient workflows, fragmented IT landscapes, and growing regulatory complexity.

1. Challenges in QA/QC

Labor-intensive documentation: Up to 30% of working time is spent on manual documentation—in less automated environments, this percentage can be even higher.
Fragmented system landscape: Lab data is often distributed across various systems (LIMS, ERP, Excel), making transparency and coordination more difficult.
Delays in batch release: Every additional day in the release process can lead to millions in losses and delay patient access to therapies.
Regulatory pressure: Current GxP guidelines demand precise documentation and traceability. New therapeutics such as biologics further increase the requirements.

2. What Modern Digital Solutions Deliver

Digital platforms designed for QA/QC offer:

Real-time dashboards that visualize task status and bottlenecks
Automated planning including resource allocation and batch simulation
System integration to avoid data fragmentation
AI-driven recommendations to improve efficiency and decision-making

These tools create a centralized workspace where QA/QC roles are clearly defined and progress is measurable—from QC managers to lab analysts.

3. Quantifiable Benefits

Up to 15% reduction in documentation time
Comparable productivity gains in operational execution
Faster batch release: on average, two days faster, accelerating time-to-market
Financial impact: For 3,000 batches per year, potential savings exceed €800,000 through more efficient use of personnel
ROI realization: Often within 3–6 months

4. Implementation Barriers

Resistance to change, especially in long-established paper-based processes
Technical and organizational challenges when integrating with existing ERP/MES systems
Need for clear benefit justification to secure investment approval

5. Key Success Factors for Implementation

User-friendly design to ensure adoption
Flexible APIs and interfaces for smooth integration with LIMS, ERP, and MES
Pharmaceutical industry focus to ensure process-specific functionality
Fast implementation with visible improvements in a short time

6. From Creative Chaos to Data-Driven Quality

The key paradigm shift is moving from reactive, paper-based processes to proactive, data-driven quality management.
Digital QA/QC solutions enable well-informed decisions, optimized planning, and faster market entry—all while maintaining full compliance.

Conclusion

A digital QA/QC system is more than a tool—it’s strategic infrastructure. It reduces documentation workload, increases transparency, accelerates batch release, and generates measurable cost savings.

The three critical success factors:

Clear goal-setting and pain-point analysis
Clean technical integration and high usability
Transparent ROI models with balanced cost-benefit analysis

From a technical and operational perspective, the business case is clear: Digitally supported quality management enhances compliance, efficiency, and long-term competitiveness.

‍

Download the Business Case here: