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LO1 Tracker

Typical Engagements

Industry Related Experience

Program/Project Management

Qualified Resources

 

 

 

 

 

Complete Range of Consulting Services      
Program & Project Management LO1 Tracker System implementation
  
Quality Assurance and Regulatory Affairs
 Design History File (DHF) Evaluations & Improvements
  
Computer Systems Validation (CSV),
and 21 CFR Part 11 Validation
 Planning, Design, Development, Documentation, Deployment (PD4) Methodology
  
Validation Master Plans
 Software Design and Development
  
Requirements Analysis, Business Analysis, and BPR
 Software Quality Assurance (SQA)
  
User and Functional Specifications
 AIDC and RFID Systems Development
  
Management Controls, Complaint Handling, CAPAs, RCA, & Failure Investigation
 Production Controls, Supply Chain, Material Controls, Facilities & Equipment
  
Design Control & Change Control
 Commissioning, Qualification & Process Validation
  
QSIT Audits and Remediation
 Process Analytical Technology (PAT)
  
Regulatory Compliance Auditing
 Document Control & Knowledge Management
  
QSR, GxP, ICH, and GAMP Compliance
 SOP Development and Remediation
  
SDLC & CSV Methodology Development
 Training and eLearning
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