PLC 21 CFR 11 Compliance
Budget / SalaryHourly project
TypeFreelance project
LocationRemote
Posted2 hours ago
We are looking for an experienced CSV and regulatory compliance consultant to support a GMP software remediation and validation project for a legacy PLC-based sterilization control system used in a regulated medical device and pharmaceutical environment.
Project Background
The system is a custom, Do-more Designer H2-DM1E PLC-based sterilization control system with a C-More HMI (Version 4.01), in continuous production use for over 10 years.
The system currently has no audit trail, no user access controls, no password management, no electronic signatures, and no SDLC documentation — requiring full 21 CFR Part 11 compliance remediation.
Scope of Work
Stage 1: Gap Analysis & Risk Assessment including Software FMEA
Stage 2: Remediation Planning & SDLC Framework (URS, FRS, Risk Management File, SOPs)
Stage 3: Technical Remediation Support & Compliance Oversight
Stage 4: IQ/OQ/PQ Validation Execution
Stage 5: Closure, Training & SOP Finalization
Required Skills & Experience
Minimum 5 years hands-on CSV and 21 CFR Part 11 experience
Experience with PLC-based systems in GMP environments
Strong knowledge of ISPE GAMP 5, FDA QMSR, ISO 13485
Experience writing and executing IQ/OQ/PQ protocols
FMEA and risk assessment experience
SOP development and training delivery
Ability to work independently and deliver on tight timelines
Project Background
The system is a custom, Do-more Designer H2-DM1E PLC-based sterilization control system with a C-More HMI (Version 4.01), in continuous production use for over 10 years.
The system currently has no audit trail, no user access controls, no password management, no electronic signatures, and no SDLC documentation — requiring full 21 CFR Part 11 compliance remediation.
Scope of Work
Stage 1: Gap Analysis & Risk Assessment including Software FMEA
Stage 2: Remediation Planning & SDLC Framework (URS, FRS, Risk Management File, SOPs)
Stage 3: Technical Remediation Support & Compliance Oversight
Stage 4: IQ/OQ/PQ Validation Execution
Stage 5: Closure, Training & SOP Finalization
Required Skills & Experience
Minimum 5 years hands-on CSV and 21 CFR Part 11 experience
Experience with PLC-based systems in GMP environments
Strong knowledge of ISPE GAMP 5, FDA QMSR, ISO 13485
Experience writing and executing IQ/OQ/PQ protocols
FMEA and risk assessment experience
SOP development and training delivery
Ability to work independently and deliver on tight timelines
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