SERVICES

VALIDATION

Project Management

Validation Life Cycle

Validation Master Plan

Validation Compliance Audit

Systems Impact Assessment

Protocols

Process Validation

SOPs

Training

Process Optimization

Cost Saving Projects

Electron Beam Sterilization

Product Transfer


COMPLIANCE

MDSAP

21 CFR Parts210/211

21 CFR Part 11

21 CFR Part 4

Quality Documents Review

GxPs Gap Assessment

Combination Products

Audit Readiness

Remediation

Data Integrity

GMP Training

QSIT Methodology

FDA Inspections

BSI Audits

RISK MANAGEMENT

ISO 14971

ICH Q9

Process Mapping

Risk Assessment

PHA

FMEA

HACCP

HAZOP

QUALITY MANAGEMENT SYSTEMS

ICH Q10

21CFR 820

ISO 13485

Quality Metrics

Quality Dash Board

Non Conformances

Investigations

CAPA Program

Performance Metrics

Data Analytics

Organizational Assessment

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