You will get Pharma Compliance & SharePoint Consultation (21 CFR Part 11 | GAMP 5)
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Project details
I help pharmaceutical, biotech, and healthcare companies ensure full compliance with 21 CFR Part 11, GAMP 5, and GxP requirements when using SharePoint or digital workflows for approvals, audit trails, e-signatures, training, or document control. With 20+ years of senior QA/Compliance experience in multinational pharma (GMP/GDP/QMS), I provide clear, actionable assessments that improve audit readiness and data integrity.
Whether you need a quick consultation, a detailed Part 11 workflow review, or a full GAMP 5/CSV validation roadmap, I analyze your workflows, permissions, metadata logic, and audit trail behavior to identify critical gaps and propose practical solutions. My approach is risk-based, aligned with FDA/EMA expectations, and designed to help you implement sustainable, inspection-ready controls.
You will receive professional, concise, and technically sound deliverables tailored to your selected package (Starter, Standard, or Advanced). My goal is to help your team gain clarity, resolve compliance concerns fast, and ensure your digital processes meet global regulatory standards with confidence.
Whether you need a quick consultation, a detailed Part 11 workflow review, or a full GAMP 5/CSV validation roadmap, I analyze your workflows, permissions, metadata logic, and audit trail behavior to identify critical gaps and propose practical solutions. My approach is risk-based, aligned with FDA/EMA expectations, and designed to help you implement sustainable, inspection-ready controls.
You will receive professional, concise, and technically sound deliverables tailored to your selected package (Starter, Standard, or Advanced). My goal is to help your team gain clarity, resolve compliance concerns fast, and ensure your digital processes meet global regulatory standards with confidence.
Project Type
Business Consulting, Legal, Training & DevelopmentWhat's included
| Service Tiers |
Starter
$65
|
Standard
$255
|
Advanced
$450
|
|---|---|---|---|
| Delivery Time | 2 days | 5 days | 9 days |
Number of Revisions | 0 | 1 | 2 |
Optional add-ons
You can add these on the next page.
Additional Revision
+$45
15-Min Follow-Up Call
+$35Frequently asked questions
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GA
Gal A.
Mar 27, 2026
MHRA Medical Device Technical File + Registration Expert Needed (UK)
About Efrain
FDA / EU MDR Regulatory & eQMS Consultant | Pharma, MedTech, SaMD & AI
100%
Job Success
Argentina, Argentina - 11:33 am local time
My work focuses on translating regulatory frameworks: FDA, EMA, MHRA, EU MDR and global GMP, into practical, operational systems including QMS architecture, eQMS implementation, audit readiness programs, technical documentation structures and compliance strategies.
I typically support companies in situations such as:
• Preparing for FDA, EMA or MHRA inspections and audits
• Building or remediating Quality Management Systems (QMS / eQMS)
• Developing regulatory documentation and technical files for medical devices and SaMD
• Strengthening compliance infrastructure for global market expansion
Clients engage me when regulatory complexity becomes a strategic barrier to growth.
Steps for completing your project
After purchasing the project, send requirements so Efrain can start the project.
Delivery time starts when Efrain receives requirements from you.
Efrain works on your project following the steps below.
Revisions may occur after the delivery date.
Initial Review
I will review your description, files, and system context to understand the compliance issue or workflow.
Compliance Assessment
I will analyze workflows, permissions, metadata, audit trail behavior, and system configuration based on 21 CFR Part 11, GAMP 5, and good documentation practices.