PLC 21 CFR 11 Compliance

₹750-1250 INR / hour

Completed

Posted 6 days ago

₹750-1250 INR / hour

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 ID: 40634876

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Active 5 days ago

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@stolzenterprises

The professional with 16 years of experience in Industrial Automation. Development,Commissioning of PLC Control System, HMI and SCADA^^ ◾ PLC-Siemens [S7-1500F/H, S7-400, S7-400F/H/R, S7-300, S7-1200, S7-200, S5, TI PLC, LOGO!] Rockwell [(Allen Bradley)- SLC500,MicroLogix,CompactLogix.] Schneider [Zelio, M171/72] Automation Direct [DirectLogic Click PLC] Unitronic [V200-18-E3XB Controller] Delta [Delta DVP ES2] ◾HMI-Siemens ** Weintek ** Kinco ** Unitronics ** Hitachi ** Schneider ** Wecon ** DeepSeaElectronics ◾SCADA -WinCC ** In-Touch Wonderware ** Citect ** Ignition ◾ Industrial Networks-PPI-MPI ** Profibus ** AS-i ** Profinet ** Ethernet ** Modbus RTU/Modbus TCP ◾ OPC -PC Access ** OPC Scout ** OPCUA ** Metrikon ** Kepware ◾ Project Documentation-ISA88/95, GAMP, 21CFR Part11, VP, URS, FRS, DS, IQ, OQ, PQ, SOP. ◾ Programming Languages -C# ** VBA ** VB.net ** Javascript ◾ Raspberry pi ** Raspi Camera ◾ Networking Devices - Siemens scalance, Teltonika, Waveshare Modbus Gateway, Moxa Gateway

₹500 INR in 1 day

5.0

(17 reviews)

4.5

3 freelancers are bidding on average ₹808 INR/hour for this job

@dholadipak09

✔Plz review my proposal and reach out to me.✔ I have rich similar experience with this kind of CSV, GMP software validation, PLC/HMI remediation, risk assessment, and regulated-system documentation. I can support the complete lifecycle from initial gap assessment through validation closure. ✔ Perform 21 CFR Part 11 gap analysis, Software FMEA, risk assessment, and identify remediation requirements for the Do-more H2-DM1E PLC/C-More HMI environment. ✔ Prepare URS, FRS, traceability matrix, risk-management documentation, validation plan, SOPs, access-control/audit-trail requirements, and SDLC framework aligned with GAMP 5 and ISO 13485 expectations. ✔ Support technical remediation and execute/document IQ, OQ, and PQ protocols, deviation handling, test evidence, training, and final validation closure. I would first assess which Part 11 controls can be implemented directly within the legacy PLC/HMI architecture and which require an external supervisory or data-integrity layer. Two questions: 1. Is modification of the existing PLC/HMI application permitted during production downtime? 2. Do you already have historical source code, drawings, calibration records, and change-control documentation? I can start with Stage 1 immediately and provide a structured remediation roadmap before implementation begins. Best regards, Dipak

₹750 INR in 40 days

0.0

(0 reviews)

0.0

@todayintech

? High-Impact Action Plan for "PLC 21 CFR 11 Compliance" I reviewed your requirements and I am ready to deliver outstanding results for you. Experienced Full-Stack Developer skilled in web applications, mobile apps, React, Node.js, and Python. ✅ Deliverables & Execution: 1. Project Setup & Architecture Review (Days 1-2) 2. Core Development & Integration (Days 3-4) 3. Quality Testing & Final Launch (Day 5) Let's connect via chat to discuss your specific goals and get started! Best regards, todayintech

₹1,175 INR in 5 days