Driving Compliance Excellence with Automation: Introducing Global Regulatory Control Framework (GRCF)

In today’s dynamic business landscape, compliance isn’t just a regulatory requirement—it’s a strategic pillar. Organizations rely on standards, regulations, and industry best practices to mitigate risks tied to governance, quality, and information security.

But here’s the reality: while working with clients, we observed a recurring challenge—control design often happens in silos. Quality and information security teams work independently, leading to interpretation bias. The result?

  • Overlapping controls (overdoing) or process gaps (underdoing)
  • Enormous time spent manually designing processes and controls
  • Error-prone variations and inconsistent adherence
  • Compliance gaps impacting quality, security, and regulatory obligations

As organizations expand into new products, markets, or geographies, they face newer regulations and standards. This demands diverse expertise and a risk-based approach to perform thorough gap assessments and achieve effective control harmonization.

The Challenges

Defining effective controls is easier said than done. Common hurdles include:

  • Limited visibility into evolving standards and regulations
  • Gaps in understanding risk-based approaches
  • A compliance-first mindset focused on avoiding penalties rather than prioritizing patient safety and benefit

These challenges highlight a critical truth: manual compliance processes are outdated and insufficient.

Why Choose GRCF?

To overcome these hurdles, automation is the game-changer. Infosys’s Global Regulatory Control Framework (GRCF) is designed to simplify governance, strengthen risk management, and harmonize compliance across diverse regulatory landscapes.

Here’s what makes GRCF transformative:

  • Assess AS-IS Maturity with Precision: Rapid gap identification in existing control registers, minimizing manual effort and accelerating remediation planning
  • Integration of Guiding Principles: Built on industry best practices and aligned with organizational risk appetite
  • Comprehensive Requirements: Consolidates regulations, standards, and business policies into a single framework
  • Broad Coverage: Spans 15 globally recognized standards and 22 critical control domains with ~300 process controls—ensuring no blind spots
  • Continuous Improvement: Identifies control gaps during assessments and provides actionable insights for enhancement
  • Reduced Effort in Gap Analysis: Quickly pinpoint gaps for faster remediation
  • Enhanced Accuracy: Improve precision in defining and implementing controls
Benefits at a Glance
  • Control Framework Harmonization: Achieve consistency across all compliance layers
  • Industry Best Practice Alignment: Stay aligned with global standards and regulations
  • Efficiency & Speed: Reduce manual effort and accelerate gap analysis
  • Confidence in Compliance: Empower IT and business teams to make informed decisions with clarity
Conclusion

Compliance is no longer a one-time activity—it’s an ongoing journey. With GRCF’s automated solution, organizations can confidently navigate this journey, ensuring robust governance, reduced risk, and sustained trust.

Looking for a unified compliance framework tailored to your organization? [Contact Us]

Author Details

Inder Neel Dua

Inder is Partner at Infosys Consulting and leads the Life Sciences unit. With over 18 years of consulting expertise, he specializes in Listening, Communication and Solutioning business objectives with practical implementation. Inder likes to simplify complex information, develop effective frameworks, and streamline delivery through change management and operational effectiveness.

Nandini Diwakar

Dr. Nandini Diwakar brings over 18+ years of Consulting expertise, establishing herself as a recognized as Governance, Risk and Compliance advisor for global Pharma clients. She is responsible for ideating, conceptualizing, and setting up large scale Compliance solution across the globe, with focus on IT Governance & GxP Compliance, Enterprise Risk Management, Regulatory Advisory & Readiness, and cutting-edge technologies (Gen AI, AI, ML, Blockchain, Cloud).

Revathy Nachimuthu

Revathy Nachimuthu serves as a Principal Consultant at Infosys Consulting, bringing over 19 years of experience across IT and Life Sciences. She is a recognized expert in Quality and Compliance services, with deep proficiency in ERP validation and a strong track record of delivering large-scale ERP transformation programs.

Leave a Comment

Your email address will not be published. Required fields are marked *