GxP Audit – Quality, Compliance, GxP Excellence

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MEDIATURE GxP

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Professional GxP, regulatory and quality management solutions for pharmaceutical and healthcare organizations.

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OUR EXPERTISE

GxP & Other Compliance Solutions

Comprehensive quality, regulatory and compliance solutions for regulated pharmaceutical organizations.

01 Commissioning, Qualification & Validation Lifecycle-based commissioning, qualification, and validation support for facilities, utilities, equipment, systems, and processes across regulated operations.

02 CSV & Digitalization Risk-based computerized-system validation, data-integrity, and digital compliance support across the GxP system lifecycle.

03 EHS, Energy & Sustainability Integrated environment, health, safety, energy, and sustainability solutions to support safer operations, regulatory compliance, resource efficiency, and long-term performance.

04 GxP Audits & Assessments Independent, risk-based audits and compliance assessments to strengthen quality systems, identify regulatory gaps, and support inspection readiness.

05 Pharmaceutical Engineering & Facility Solutions GMP-focused engineering and facility solutions from concept development through design, implementation, qualification, and operational readiness.

06 Pharmacovigilance Services End-to-end pharmacovigilance and drug-safety support across the product lifecycle to help organizations manage safety information, regulatory obligations, and patient-risk monitoring.

07 Product Development & Technology Transfer Technical support for product and process development, scale-up, optimization, and structured technology transfer across pharmaceutical operations.

08 Quality & Compliance Practical quality-system and compliance support to strengthen control, improve consistency, and maintain inspection readiness.

09 Regulatory Strategy & Intelligence Strategic and operational regulatory support across product development, submissions, approvals, and lifecycle management.

10 Training & Capability Development Practical, role-based training programs designed to strengthen GxP knowledge, compliance culture, technical capability, and workforce performance.

01 · COMMISSIONING, QUALIFICATION & VALIDATION

Lifecycle-based commissioning, qualification, and validation support for facilities, utilities, equipment, systems, and processes across regulated operations.

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Commissioning & Qualification Structured commissioning and qualification support to verify that facilities, utilities, equipment, and... Facility Qualification Structured qualification support to verify that pharmaceutical and life-sciences facilities are designed,... Utility Qualification Risk-based qualification support to demonstrate that critical utility systems are properly installed,... Equipment Qualification Structured qualification support to verify that equipment is properly installed, operates as... HVAC and Cleanroom Qualification Structured qualification support to verify that HVAC systems and cleanrooms consistently maintain... Process Validation Lifecycle-based process validation support to demonstrate that manufacturing processes consistently deliver products... Cleaning Validation Risk-based cleaning validation support to demonstrate effective removal of product residues, cleaning... Validation Master Plan Structured validation planning to define scope, responsibilities, priorities, documentation, and lifecycle control... Qualification Protocols & Reports Clear, traceable, and risk-based qualification documentation to support compliant execution, evidence review,... Periodic Review & Requalification Risk-based periodic review and requalification support to confirm that facilities, utilities, equipment,... Validation Lifecycle Support End-to-end validation lifecycle support to help maintain facilities, utilities, equipment, systems, and...

02 · CSV & DIGITALIZATION

Risk-based computerized-system validation, data-integrity, and digital compliance support across the GxP system lifecycle.

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Computer System Validation Lifecycle-based validation support to demonstrate that GxP computerized systems are fit for... Data Integrity Assessment Structured assessment of data governance, systems, processes, and controls to help ensure... 21 CFR Part 11 Compliance Compliance support for electronic records and electronic signatures used in FDA-regulated GxP... Digital QMS Compliance-focused support for implementing, validating, optimizing, and maintaining electronic Quality Management Systems... Computer Software Assurance Risk-based software assurance focused on critical functions, intended use, patient safety, product... GAMP 5 Compliance Risk-based GxP computerized-system lifecycle support aligned with GAMP 5 principles for reliable,... EU Annex 11 Compliance Lifecycle-based compliance support for computerized systems used in GMP-regulated environments, with focus... Electronic Document Management Systems Compliance-focused support for implementing, validating, and maintaining controlled electronic document-management systems across... Data Migration Validation Risk-based validation support to help ensure that GxP data transferred between systems... Interface & API Validation Risk-based validation support for system-to-system interfaces and APIs to help ensure complete,... Cloud System Assessment Risk-based assessment and compliance support for cloud-hosted GxP applications, infrastructure, data, suppliers,... Vendor & System Qualification Risk-based qualification of software vendors, service providers, and GxP computerized systems to... Digital Transformation Support Compliance-focused digital transformation support to help regulated organizations modernize processes, systems, workflows,...

03 · EHS, ENERGY & SUSTAINABILITY

Integrated environment, health, safety, energy, and sustainability solutions to support safer operations, regulatory compliance, resource efficiency, and long-term performance.

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Energy Practical energy-management solutions to help organizations reduce energy consumption, improve utility efficiency,... EHS Practical EHS solutions to help organizations manage workplace risks, strengthen compliance, improve... Sustainability Practical sustainability solutions to help organizations improve resource efficiency, reduce waste, strengthen...

04 · GXP AUDITS & ASSESSMENTS

Independent, risk-based audits and compliance assessments to strengthen quality systems, identify regulatory gaps, and support inspection readiness.

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Computerized System / CSV Audits Independent audits to assess computerized-system compliance, strengthen data governance, and protect the... GVP / Pharmacovigilance Audits Independent pharmacovigilance audits to assess system compliance, strengthen safety processes, and support... GMP Audits Independent GMP audits to identify compliance gaps, strengthen quality systems, and support... GDP Audits Independent GDP audits to strengthen storage, transportation, traceability, and distribution controls across... Vendor and Supplier Audits Independent supplier and vendor audits to strengthen qualification, oversight, and compliance across... GLP Audits Independent GLP audits to strengthen laboratory quality systems, protect data integrity, and... GCP Audits Independent GCP audits to protect participant rights, strengthen clinical quality systems, and... Quality System Audits Independent quality-system audits to identify compliance gaps, strengthen QMS effectiveness, and support... Engineering Compliance Audits Independent audits to assess facility design, engineering systems, utilities, maintenance, qualification status,... Factory Acceptance Testing (FAT) Audits / Witnessing Independent FAT audit and witnessing support to verify equipment compliance, functionality, documentation,... Due Diligence / Gap Assessments Independent assessments to identify compliance risks, evaluate operational readiness, and support informed...

05 · PHARMACEUTICAL ENGINEERING & FACILITY SOLUTIONS

GMP-focused engineering and facility solutions from concept development through design, implementation, qualification, and operational readiness.

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Equipment Selection & Technical Evaluation Structured equipment selection and technical evaluation support to improve process fit, GMP... HVAC & Cleanroom Qualification Specialized HVAC and cleanroom engineering support to maintain environmental control, contamination control,... Conceptual, Basic and Detailed Engineering Integrated engineering support from early concept through detailed design to help deliver... New Facility Planning & Design Integrated facility planning and design support to build compliant, efficient, scalable, and... GMP Engineering Compliance Engineering compliance support to align facilities, utilities, equipment, and technical systems with... Utility Systems Design & Assessment Engineering support for reliable, compliant, and efficient utility systems serving pharmaceutical and... Engineering Project Management Structured project-management support to coordinate engineering, quality, vendors, timelines, risks, and execution... Procurement Support Technical procurement support to improve vendor selection, specification control, commercial clarity, and... Construction & Installation Support On-site and technical execution support to help ensure that pharmaceutical facilities, utilities,... High-Potency & Containment Facility Design Specialized facility and engineering support for high-potency, hazardous, and containment-sensitive manufacturing environments. Turnkey Engineering Support Integrated engineering support from concept and design through execution, coordination, qualification interface,... Green Building & Sustainable Facility Design Sustainable facility planning and engineering support to improve energy efficiency, resource utilization,... Facility Layout Review Independent GMP-focused layout review to improve flow, segregation, contamination control, operational efficiency,...

06 · PHARMACOVIGILANCE SERVICES

End-to-end pharmacovigilance and drug-safety support across the product lifecycle to help organizations manage safety information, regulatory obligations, and patient-risk monitoring.

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ICSR Case Management End-to-end Individual Case Safety Report processing support to help ensure complete, accurate,... Safety Database Management Reliable safety database support to help ensure accurate case capture, controlled workflows,... Signal Management Structured signal detection, assessment, prioritization, and tracking support to help identify and... Literature Monitoring Structured literature surveillance to identify reportable safety information, emerging risks, and relevant... Aggregate Reporting Structured aggregate safety reporting support to help organizations evaluate cumulative safety data,... Risk Management Structured pharmacovigilance risk-management support to identify, characterize, monitor, minimize, and communicate important... PV SOP Development Practical, role-based pharmacovigilance SOP development to help organizations standardize safety activities, define... PV Training Practical, role-based pharmacovigilance training designed to strengthen safety knowledge, operational consistency, regulatory... SDEA/PVA Management Structured safety agreement support to clearly define pharmacovigilance responsibilities, safety-data exchange requirements,... PSMF Support Structured Pharmacovigilance System Master File support to help organizations document, maintain, and... PV Quality & Compliance Quality-system and compliance support to help organizations maintain controlled, consistent, traceable, and...

07 · PRODUCT DEVELOPMENT & TECHNOLOGY TRANSFER

Technical support for product and process development, scale-up, optimization, and structured technology transfer across pharmaceutical operations.

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Product Development Support Structured technical support to help pharmaceutical and life-sciences organizations plan, develop, evaluate,... Process Development Technical process-development support to help establish robust, reproducible, scalable, and manufacturable processes... Analytical Development Support Technical support for analytical method planning, development coordination, method transfer, validation readiness,... Technology Transfer Structured technology-transfer support to help ensure that product, process, analytical, and manufacturing... Scale-Up Support Structured technical support to help transition pharmaceutical products and processes from development... Process Optimization Technical process-optimization support to improve robustness, reproducibility, efficiency, yield, and overall manufacturing... Technical Troubleshooting Structured technical troubleshooting support to identify root causes, resolve recurring manufacturing or... Formulation Development Support Technical support for formulation planning, evaluation, optimization, and documentation to help develop...

08 · QUALITY & COMPLIANCE

Practical quality-system and compliance support to strengthen control, improve consistency, and maintain inspection readiness.

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Change Control Structured change-control support to assess impact, manage risk, and maintain the validated... Quality Management System Development Structured QMS development and improvement support to strengthen governance, compliance, consistency, and... CAPA Management Structured CAPA support to address root causes, prevent recurrence, and strengthen quality-system... Deviation & OOS/OOT Management Structured investigation and quality-event management support to identify root causes, reduce recurrence,... Data Integrity & Good Documentation Practices Practical data-integrity and documentation support to strengthen record reliability, traceability, accountability, and... Quality Risk Management (QRM) Structured, science-based risk management support to identify, evaluate, control, communicate, and review... Gap Assessment & Remediation Structured compliance gap assessments and practical remediation support to strengthen systems, reduce... SOP Development & Review Practical SOP development and lifecycle support to standardize processes, strengthen compliance, and... Contamination Control Strategy Structured contamination-control support to identify contamination risks, strengthen preventive controls, and maintain... Inspection Readiness Structured inspection-readiness support to strengthen systems, prepare teams, and reduce regulatory risk... Quality Metrics & Management Review Structured quality-performance monitoring and management-review support to strengthen oversight, identify trends, and...

09 · REGULATORY STRATEGY & INTELLIGENCE

Strategic and operational regulatory support across product development, submissions, approvals, and lifecycle management.

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Medical & Regulatory Writing Clear, accurate, and compliant scientific writing support for regulatory, clinical, safety, and... Regulatory Strategy and Intelligence Practical regulatory planning and intelligence support to help organizations understand requirements, select... Dossier Compilation & Review Structured dossier preparation and technical review support to improve completeness, consistency, and... CTD/eCTD Support Structured CTD and eCTD support to improve dossier organization, technical consistency, and... Regulatory Submission Support Coordinated regulatory submission support to improve completeness, consistency, and readiness across application... Regulatory Query Response Support Structured support for assessing, coordinating, drafting, and tracking responses to regulatory authority... Product Registration Support Structured product registration support to help organizations prepare compliant documentation, coordinate submissions,... Variations & Renewals Structured post-approval regulatory support to manage product changes, maintain registrations, and ensure... Regulatory Lifecycle Management Ongoing regulatory support to maintain product approvals, manage post-approval obligations, and keep... Artwork & Labelling Review Regulatory and quality-focused review of product labelling and artwork to improve accuracy,... Regulatory Gap Assessment Structured regulatory assessments to identify documentation, compliance, and lifecycle gaps before they...

10 · TRAINING & CAPABILITY DEVELOPMENT

Practical, role-based training programs designed to strengthen GxP knowledge, compliance culture, technical capability, and workforce performance.

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GMP & GxP Training Practical training to strengthen understanding of GMP principles, GxP requirements, documentation practices,... Regulatory & Guidelines Training Practical training to help teams understand applicable regulations, guidelines, and their impact... Data Integrity Training Practical training to strengthen understanding of ALCOA+ principles, reliable documentation, electronic records,... Soft Skills & Workforce Enhancement Practical training to strengthen communication, teamwork, leadership, problem-solving, and professional effectiveness across... Train-the-Trainer Programs Practical programs designed to strengthen internal trainers’ ability to deliver clear, engaging,... CSV & GAMP Training Practical training on computerized-system validation, GAMP principles, risk-based assurance, data integrity, and... Quality & Compliance Training Practical training to strengthen quality-system understanding, investigation skills, documentation, risk-based thinking, and... Industrial & Graduate Training Practical industry-oriented training to help students, fresh graduates, and early-career professionals understand... EHS & Safety Training Practical training to strengthen workplace safety awareness, hazard control, emergency preparedness, and... Audit Readiness & Auditor Development Practical training to strengthen audit preparation, auditor skills, inspection behaviour, evidence-based assessment,... Qualification & Validation Training Practical training to strengthen understanding of qualification, validation, lifecycle documentation, and risk-based... Pharmacovigilance Training Practical, role-based training to strengthen pharmacovigilance knowledge, case quality, regulatory compliance, and...

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Commissioning & Qualification Facility Qualification Utility Qualification Equipment Qualification HVAC and Cleanroom Qualification Process Validation Cleaning Validation Validation Master Plan Qualification Protocols & Reports Periodic Review & Requalification Validation Lifecycle Support

Computer System Validation Data Integrity Assessment 21 CFR Part 11 Compliance Digital QMS Computer Software Assurance GAMP 5 Compliance EU Annex 11 Compliance Electronic Document Management Systems Data Migration Validation Interface & API Validation Cloud System Assessment Vendor & System Qualification Digital Transformation Support

View All Energy Comprehensive Energy Audits Utility Consumption Assessment HVAC Energy Optimization Compressed Air System Efficiency Audits Boiler & Steam System Optimization Chiller & Cooling System Performance Assessment Electrical System Energy Audits Renewable Energy Feasibility Studies

View All EHS EHS Gap Assessment Occupational Health & Safety Hazard Identification & Risk Assessment (HIRA) Process Safety Management (PSM) Fire & Life Safety Audits Emergency Response Planning Environmental Compliance Audits Waste Management

View All Sustainability Waste Reduction Resource Optimization Green Building Support Sustainability Programs

Computerized System / CSV Audits GVP / Pharmacovigilance Audits GMP Audits GDP Audits Vendor and Supplier Audits GLP Audits GCP Audits Quality System Audits Engineering Compliance Audits Factory Acceptance Testing (FAT) Audits / Witnessing Due Diligence / Gap Assessments

Equipment Selection & Technical Evaluation HVAC & Cleanroom Qualification Conceptual, Basic and Detailed Engineering New Facility Planning & Design GMP Engineering Compliance Utility Systems Design & Assessment Engineering Project Management Procurement Support Construction & Installation Support High-Potency & Containment Facility Design Turnkey Engineering Support Green Building & Sustainable Facility Design Facility Layout Review

View All ICSR Case Management Case Processing Quality & Medical Review Regulatory Reporting

View All Safety Database Management Data Entry & Validation E2B (R3) XML Generation

View All Signal Management Signal Detection & Evaluation

View All Literature Monitoring Weekly Literature Screening

View All Aggregate Reporting PSUR/PBRER Support

View All Risk Management RMP & REMS Support

View All PV SOP Development SDEA/PVA Management SOP Development PSMF Support

View All PV Training SOP Training

SDEA/PVA Management PSMF Support PV Quality & Compliance

Product Development Support Process Development Analytical Development Support Technology Transfer Scale-Up Support Process Optimization Technical Troubleshooting Formulation Development Support

Change Control Quality Management System Development CAPA Management Deviation & OOS/OOT Management Data Integrity & Good Documentation Practices Quality Risk Management (QRM) Gap Assessment & Remediation SOP Development & Review Contamination Control Strategy Inspection Readiness Quality Metrics & Management Review

Medical & Regulatory Writing Regulatory Strategy and Intelligence Dossier Compilation & Review CTD/eCTD Support Regulatory Submission Support Regulatory Query Response Support Product Registration Support Variations & Renewals Regulatory Lifecycle Management Artwork & Labelling Review Regulatory Gap Assessment

View All GMP & GxP Training GMP, GDP & GLP Data Integrity & ALCOA++ Principles GxP Fundamentals & Best Practices

View All Regulatory & Guidelines Training Schedule M Updates US FDA Requirements MHRA Requirements GAMP 5 & Computerized Systems Regulatory Updates & Compliance Changes

View All Data Integrity Training Fundamentals Refresher Practical, Interactive & Case-Based Learning Latest Regulatory & GMP Changes

View All Soft Skills & Workforce Enhancement Productivity Enhancement Personality Development Communication & Team Effectiveness Workforce Enhancement

View All Train-the-Trainer Programs Trainer Development & Assessment Effective Training Techniques

View All CSV & GAMP Training GMP Audit Skills Auditor Development Audit Preparation & Execution Observation Writing & Reporting

View All Quality & Compliance Training Workplace Awareness & Compliance Prevention of Sexual Harassment

View All Industrial & Graduate Training Training Programs for College Freshers & Graduates Practical GxP Training Pharma Industry Orientation

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Mediature GxP Solutions Private Limited provides professional GxP, GMP, quality, regulatory, pharmacovigilance and pharmaceutical consulting solutions to support quality, compliance and operational excellence.

GXP AUDIT – QUALITY, COMPLIANCE, GXP EXCELLENCE

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