What Is Gap Assessment & Remediation?

Gap Assessment identifies compliance deficiencies in your quality management systems, processes, documentation, or organizational practice compared to regulatory standards like FDA, EMA, ICH, GMP, or ISO  
Remediation involves implementing tailored corrective actions—such as updated SOPs, training programs, validation activities, and CAPA systems—to close those gaps and maintain compliance . 

Why Should Clients Leverage This Service? 

• Regulatory & Operational Safeguards: Proactively discover and fix compliance issues to avoid inspection risks, recalls, or penalties. 

• Efficiency & Cost Reduction: Streamlining documentation and processes avoids costly rework while improving effectiveness  

• Quality Excellence: Integrating risk management, root cause analysis, and CAPA enhances product quality and safety  

• Continuous Improvement Culture: Ongoing assessment and monitoring ensure your system stays compliant as regulations evolve. 

How BioBoston Consulting Delivers Value 

As your One Stop Solution for Life Sciences, we manage the full lifecycle of gap assessment and remediation: 

• Comprehensive Assessments – Examine your processes, documentation, systems, and practices thoroughly  

• Strategic Remediation Planning – Create action-oriented, risk-based remediation plans customized for your organization  

• Implementation Support – Assist with carrying out remediation: updating SOPs, conducting training, performing validations, and deploying CAPA systems  

• Regulatory Documentation Review – Verify that updated documents align with regulations and audit expectations  

• Training & Education – Empower your team with training on revised procedures, risk, GMP, and quality controls. 

• Ongoing Monitoring & Support – Continuously track remediation success using KPIs, perform follow-up reviews, and refresh your approach as needed  

Who’s Responsible for This Service? 

This initiative is led by a Quality Assurance/Quality Systems Lead (often called QMS Lead) or a designated Gap Assessment Manager, who partners closely with Regulatory Affairs, R&D, Manufacturing, and Senior Management. They take charge of assessments, action plans, CAPA execution, training, and monitoring. 

Client Benefits Snapshot 

Benefit	Outcome
Regulatory Resilience	Audit-ready with fewer compliance incidents
Operational Efficiency	Smoother processes and reduced rework
Quality & Safety	Builtin checks via risk based remediation and CAPA
Sustainable Compliance	Continual evolution with regulatory changes
Holistic Improvement	Aligns QMS, SOPs, training, and audits across departments

 

Ready to Close the Gaps in Your Compliance Program? 

Contact BioBoston Consulting today to initiate your Gap Assessment & Remediation project. As your One Stop Solution for Life Sciences, we are your partner in achieving regulatory readiness, operational excellence, and sustainable quality management.