Gap Assessment & Remediation

Overview

Gap assessments help organizations understand where their current systems, processes, documentation, facilities, and controls differ from applicable regulatory or quality expectations.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent gap-assessment and remediation support for pharmaceutical, biopharmaceutical, API, medical-device, clinical, laboratory, pharmacovigilance, and other regulated organizations.

Our approach goes beyond identifying deficiencies. We help clients understand the significance of each gap, prioritize actions based on risk, develop practical remediation plans, strengthen documentation and systems, and verify implementation effectiveness.

Our Gap Assessment & Remediation Services

Regulatory Compliance Gap Assessments

Evaluation of existing systems and practices against applicable national and international regulatory requirements and guidance.

GMP & GxP Gap Assessments

Assessment of manufacturing, quality, laboratory, engineering, validation, computerized-system, clinical, distribution, and pharmacovigilance activities.

Quality System Gap Assessments

Review of QMS elements such as deviations, CAPA, change control, investigations, training, document control, quality risk management, and management oversight.

Facility & Engineering Gap Assessments

Assessment of facility design, HVAC, utilities, equipment, segregation, material and personnel flow, contamination control, and engineering documentation.

Validation Gap Assessments

Review of qualification and validation programs, validation master plans, protocols, reports, lifecycle controls, and requalification practices.

Data Integrity Gap Assessments

Evaluation of paper and electronic data practices, audit trails, access controls, documentation practices, review mechanisms, record retention, and governance.

Computerized System Gap Assessments

Review of computerized-system validation status, system controls, electronic records, security, vendor oversight, and lifecycle documentation.

Inspection Readiness Gap Assessments

Focused assessment of systems, documents, facilities, and personnel preparedness before regulatory inspections or customer audits.

Post-Inspection Remediation

Support for addressing regulatory observations, audit findings, warning letters, inspection deficiencies, or recurring compliance issues.

Key Areas We Assess

Depending on the scope, MGS may evaluate:

• Quality Management System
• SOPs and controlled documents
• Deviations and investigations
• CAPA
• Change control
• Quality risk management
• Training and competency
• Manufacturing operations
• Laboratory systems
• Data integrity
• Computerized systems
• Facilities and utilities
• HVAC and cleanrooms
• Equipment lifecycle
• Qualification and validation
• Cleaning validation
• Supplier oversight
• Warehousing and distribution
• Pharmacovigilance systems
• Regulatory documentation
• Contamination control
• Management oversight
• Quality metrics
• Inspection readiness

Our Remediation Approach

• Assess

Review current systems, processes, documentation, facilities, and practices against applicable requirements.

• Identify Gaps

Document deficiencies, inconsistencies, missing controls, and areas requiring improvement.

• Prioritize

Classify gaps based on potential impact on patient safety, product quality, data integrity, compliance, and business continuity.

• Develop the Remediation Plan

Define corrective actions, responsibilities, priorities, timelines, and required documentation.

• Support Implementation

Assist with SOP revision, system strengthening, documentation development, training, validation, CAPA, and other remediation activities.

• Verify Effectiveness

Review implementation status and confirm whether corrective actions have adequately addressed the identified gaps.

Deliverables

Depending on the agreed scope, MGS can provide:

• Gap-assessment plan
• Detailed gap-assessment report
• Risk-based gap classification
• Compliance-risk summary
• Remediation roadmap
• CAPA recommendations
• SOP and documentation improvement support
• Implementation tracker
• Inspection-readiness action plan
• Effectiveness review
• Follow-up assessment

Why Choose MGS for Gap Assessment & Remediation

Multidisciplinary Expertise

MGS can combine quality, regulatory, engineering, validation, laboratory, computerized-system, pharmacovigilance, and EHS expertise within a single assessment.

Risk-Based Prioritization

Findings are prioritized so clients can focus resources on the issues with the greatest potential impact.

Practical Remediation

Recommendations are designed to be realistic, implementable, and aligned with the client’s operating environment.

Implementation Support

MGS can support clients from initial assessment through remediation, documentation improvement, training, CAPA, validation, and follow-up review.

Independent Perspective

An objective external review can help identify systemic weaknesses that may be overlooked during routine internal operations.

Inspection Readiness Focus

Our remediation approach is designed to strengthen systems for sustainable compliance, not simply to close individual findings.

Who We Support

MGS can provide gap assessment and remediation support for:

• Pharmaceutical manufacturers
• API manufacturers
• Finished dosage form facilities
• Biopharmaceutical organizations
• Medical-device companies
• Clinical research organizations
• Laboratories
• Contract manufacturers
• CROs and service providers
• Pharmacovigilance functions
• Warehouses and distribution operations
• New, expanding, or remediating facilities