Our Projects

Examples of All Service Related Projects

Full-Service Application Management and Technical Support

Full-Service Application Management and Technical Support

Technical Writing for San Francisco Biotech Company

Technical Writing for San Francisco Biotech Company

Software Validation

Software Validation

Computer System Validation (CSV) Services

Computer System Validation (CSV) Services

Validation, Audit, and Technical Management services

Validation, Audit, and Technical Management services

Engineering and CQV Services for Pharmaceutical Client

Engineering and CQV Services for Pharmaceutical Client

Equipment Validation Support for Container Closure Integrity Testers

Equipment Validation Support for Container Closure Integrity Testers

Stability Chamber Qualification

Stability Chamber Qualification

Engineering, Commissioning, Qualification and Validation Services for the Life Science Industry

Engineering, Commissioning, Qualification and Validation Services for the Life Science Industry

Packaging and Equipment Validation

Packaging and Equipment Validation

International Veterinary Vaccine Registration

International Veterinary Vaccine Registration

 Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

 Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

cGMP Program Compliance and Gap Analysis

cGMP Program Compliance and Gap Analysis

Temperature Controlled Chamber Qualification

Temperature Controlled Chamber Qualification

Auditing – Quality Systems and Records

Auditing – Quality Systems and Records

Cleaning Validation Risk Assessment

Cleaning Validation Risk Assessment

Regulatory Agency Inspection Preparation & Quality Oversight

Regulatory Agency Inspection Preparation & Quality Oversight

Validation & Qualification | AQUATHERM SWS sterilizer (Syntegon)

Validation & Qualification | AQUATHERM SWS sterilizer (Syntegon)

QA CSV | System Implementation & Upgrading

QA CSV | System Implementation & Upgrading

Regulatory Affairs | Vaccine Registration

Regulatory Affairs | Vaccine Registration

Quality Assurance | New Product Development Projects

Quality Assurance | New Product Development Projects

Calibration Software | CSV | Risk Assessment, Qualification, and Validation  

Calibration Software | CSV | Risk Assessment, Qualification, and Validation  

Commissioning | Utilities and Facility

Commissioning | Utilities and Facility

Regulatory Affairs, Technical Writing | IND Modification for Phase I Clinical Trial

Regulatory Affairs, Technical Writing | IND Modification for Phase I Clinical Trial

Nutritional Supplement Manufacturing Facilities

Nutritional Supplement Manufacturing Facilities

cGMP Compliance and Gap Analysis

cGMP Compliance and Gap Analysis

Audit Inspection of cGMP Facility

Audit Inspection of cGMP Facility

Metrology | Kaye Validator 2000, SIMs, TC and Drywell

Metrology | Kaye Validator 2000, SIMs, TC and Drywell

Metrology |  Temp/Humidity Circular Chart Recorder

Metrology |  Temp/Humidity Circular Chart Recorder

Metrology | Power Scientific Stability Chamber

Metrology | Power Scientific Stability Chamber

Metrology | Field & Lab Metrology

Metrology | Field & Lab Metrology

Engineering | Documentation Support for the B1 Exit Program

Engineering | Documentation Support for the B1 Exit Program

Engineering | Facilities, Utilities & Process Equipment

Engineering | Facilities, Utilities & Process Equipment

Regulatory Affairs | Strategy Support Projects

Regulatory Affairs | Strategy Support Projects

Extensive Technical Writing & Validation Execution 

Extensive Technical Writing & Validation Execution 

Technical Writing | Conducting Investigations & Resolving Nonconformance’s

Technical Writing | Conducting Investigations & Resolving Nonconformance’s

Technical Writing | Researching Errors & Inconsistencies In Existing Records

Technical Writing | Researching Errors & Inconsistencies In Existing Records

Technical Writing | Engineering Projects & New Equipment Implementation

Technical Writing | Engineering Projects & New Equipment Implementation

Technical Writing | Validation & Compliance for Computerized Systems   

Technical Writing | Validation & Compliance for Computerized Systems   

Non-Medical Technical Writing Support Project 

Non-Medical Technical Writing Support Project 

CSV  |  Remediation Validation & Compliance Project Management Project

CSV  |  Remediation Validation & Compliance Project Management Project

CSV | CRM & Vault Modules Projects

CSV | CRM & Vault Modules Projects

CA+Ireland Full Spectrum Projects

CA+Ireland Full Spectrum Projects

Commissioning and Qualification Projects

Commissioning and Qualification Projects

Assessing the Quality Systems and Records

Assessing the Quality Systems and Records

Global Auditing of Quality and Manufacturing Systems

Global Auditing of Quality and Manufacturing Systems

CQV | Multiple Facilities Projects

CQV | Multiple Facilities Projects

Sterile Fill Laboratory Facilities

Sterile Fill Laboratory Facilities

Cleaning Validation Decommissioning Project

Cleaning Validation Decommissioning Project

20 Years CQV Services

20 Years CQV Services

Greenville Facility Buildout

Greenville Facility Buildout

How Can We Help You?