The pharmaceutical industry operates under some of the world’s most rigorous regulatory frameworks, including Good Manufacturing Practice (GMP) and GxP. Manual compliance processes are not only time-consuming but also incredibly prone to human errors that can lead to costly fines, product recalls, and jeopardised patient safety.
Automated compliance solutions leverage technology to monitor, track, report, and enforce regulatory requirements continuously. Here are the top five ways this shift is revolutionising the pharma landscape:
Automation Improves Data Integrity and Accuracy
Automated systems virtually eliminate the risk of human error associated with manual tasks, such as data entry, transcription, and cross-checking across different systems. In an industry where data integrity is paramount, from clinical trials to batch records, compliance automation ensures accurate, consistent, and tamper-proof data collection in real-time. This continuous, error-free data stream is fundamental to ensuring product quality and safety.
Automated Compliance Genuinely Saves Pharmaceutical Companies Money
While the initial investment exists, automated compliance leads to significant long-term cost reduction. This is achieved in several ways:
Reduced labour costs: Automation handles repetitive, administrative compliance tasks, freeing up highly skilled staff for high-value activities.
Minimised fines and penalties: By ensuring continuous adherence to regulations, companies drastically reduce the risk of costly non-compliance incidents, fines, and legal action.
Lower costs associated with errors: Fewer errors mean less waste, fewer product recalls, and less time spent on investigation and remediation.
Automation Helps Companies Stay “Audit-Ready” 24/7
Automated systems simplify and streamline the entire audit process. They automatically generate and maintain detailed, centralised audit trails and pharma compliance documentation for every process, piece of equipment, and data point. When a regulatory body like the FDA or EMA arrives, the required evidence is organised, instantly accessible, and verifiable. This enhanced transparency and documentation significantly reduce audit preparation time and stress, turning reactive audits into proactive demonstrations of compliance.
Does Compliance Automation Platform Slow Down Operations, or Does it Improve Efficiency?
It dramatically improves efficiency and speed. Manual compliance workflows, like documentation review, approval sign-offs, and quality checks, often create operational bottlenecks. Automation digitises these workflows, speeding up processes like:
- Deviation and Corrective Action/Preventive Action (CAPA) tracking.
- Training record management.
- Automated reporting for regulatory submissions.
By accelerating these essential but time-consuming tasks, companies can bring life-saving drugs to market faster and maintain higher overall productivity.
Automated Compliance Systems Adapt to Constant Regulatory Change
A key advantage of modern compliance automation is its agility. Global regulations are constantly evolving, making manual tracking a nightmare for multinational pharma companies. Automated compliance platforms can be designed to track, integrate, and enforce updated regulatory requirements in real-time. They provide continuous monitoring and can automatically flag potential issues based on the latest standards, ensuring the business can pivot and adapt quickly without lengthy, manual policy updates across multiple sites and systems.
Canarys helps Maintain Global Compliance at Scale
Canarys helps multinational pharma companies to function normally by ensuring a smooth compliance automation system. This actually ensures facilitation of a sound business ecosystem and robust growth in revenue. We define the business of the future.