Pharma & Bio-Tech
We provide services to pharmaceuticals, medical device, compounding centers, logistics, pharmacies and healthcare organizations. Diversa’s experienced team has been engaged in regulated environments for as long as twenty years. We have the management resources necessary to fulfill almost any aspect of the industry with unsurpassed quality, commitment and professionalism.
VALIDATION & Regulatory compliance
Validation Project Management
Validation Master Plans
Quality Risk Assessments
Validation Gap Analysis
User/Functional Requirements Specifications
Factory Acceptance Tests (FAT)
Commissioning, Qualifications and Decommissioning
IQ, OQ, PQ Protocols and Reports Development and Execution
Computer Systems Validation (CSV)
Cleaning Validation
Process Validation and Investigations
Laboratory Equipment Validation
Environmental Monitoring
Products Method Transfer
Manufacturing/Packaging Equipment Qualification
Regulatory Assessments
Regulatory Compliance Remediation
CAPA, FMEA & RCA
SOPs, Guidelines Development and Revisions
IT Systems
Serialization Support
ENGINEERING & FACILITIES SUPPORT
Facilities & GMP Utilities Commissioning and Qualification
Temperature and Humidity Mapping
Project Scheduling and Budget Management
HEALTH CARE COMPLIANCE
Compliance Evaluation Assessment
DISTRIBUTION CENTERS
GMP Compliance Evaluation
Quality Risk Assessments
Regulatory Compliance Remediation
Process Optimization
ERP Software Validation
CFR Part 11, 210, 211 & 820
LEAN MANUFACTURING & SIX SIGMA
5S
Kaizen
Standardization
Value Stream Mapping
Kanban, Poka Yoke
System Simulation
Value Added Assessment
Resources & Facilities Rightsizing
Trainings
Technical Writing
CFR Part 11, 210, 211 & 820
Good Documentation Practices
Good Manufacturing Practices
Good Laboratory Practices
Good Distribution and Storage Practices
Validation and Qualification Life-Cycle
HIPAA Law