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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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