You will get ISO 27001 Gap Analysis
Project details
Get a senior-level ISO/IEC 27001:2022 gap assessment tailored to your company’s compliance posture, business model, and cloud architecture.
This service is ideal for B2B SaaS, ERP/data platforms, and compliance-heavy startups preparing for certification or, e.g. aligning SOC 2 workflows with ISO 27001.
The analysis includes clause-by-clause and Annex A review aligned with ISO/IEC 27001:2022 Clauses 4–10 and all 93 Annex A controls. Gaps, risks, and maturity levels are clearly identified. The Advanced tier includes a fully justified Statement of Applicability (SoA) with risk-aligned rationale.
Designed to work alongside modern compliance automation tools such as Drata and Vanta, ensuring control mappings, evidence structures, and workflows meet ISO 27001 expectations and support streamlined certification paths.
Assessment of your priorities and business posture included to inform financial planning and software recommendations.
Whether pre-certification or mid-implementation, this service delivers:
• ISO 27001:2022 gap report
• Control maturity evaluation
• Remediation roadmap
• Risk-based SoA (Advanced tier)
• Strategic guidance for internal audit preparation
This service is ideal for B2B SaaS, ERP/data platforms, and compliance-heavy startups preparing for certification or, e.g. aligning SOC 2 workflows with ISO 27001.
The analysis includes clause-by-clause and Annex A review aligned with ISO/IEC 27001:2022 Clauses 4–10 and all 93 Annex A controls. Gaps, risks, and maturity levels are clearly identified. The Advanced tier includes a fully justified Statement of Applicability (SoA) with risk-aligned rationale.
Designed to work alongside modern compliance automation tools such as Drata and Vanta, ensuring control mappings, evidence structures, and workflows meet ISO 27001 expectations and support streamlined certification paths.
Assessment of your priorities and business posture included to inform financial planning and software recommendations.
Whether pre-certification or mid-implementation, this service delivers:
• ISO 27001:2022 gap report
• Control maturity evaluation
• Remediation roadmap
• Risk-based SoA (Advanced tier)
• Strategic guidance for internal audit preparation
Cybersecurity Expertise
Configuration Management, Risk Assessment, Gap AnalysisTechnology Type
IaaS, Computer Network, Data Center, Database, Operating System, SaaS, Web Application, CRM, ERP, Mobile Device, PaaSCybersecurity Regulation
GDPR, ISO, HIPAA, NIST Cybersecurity Framework, SOC 2What's included
| Service Tiers |
Starter
$1,000
|
Standard
$1,500
|
Advanced
$3,500
|
|---|---|---|---|
| Delivery Time | 5 days | 10 days | 20 days |
Compliance Plan | - | - | |
Gap Analysis | |||
Implementation | - | - | - |
Frequently asked questions
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ML
Mark L.
Sep 25, 2025
A documentation and LMS specialist to help us rewrite our training materials
Reliable, thoughtful and efficient. Able to systemise thoughts and ideas efficiently. Easy to work with
JT
Julia T.
Aug 25, 2025
Documentation Specialist for R&D Software
Vadym was extremely helpful and detail-oriented with our GxP work. He handled test cases related to CFR Part 11 and EU Annex 11 compliance, and prepared the necessary FRS for our project. He onboarded quickly, communicated clearly, and consistently met deadlines. His advice on key GxP decisions was invaluable, and his contributions strengthened our regulatory compliance efforts. I would highly recommend him to any team looking for reliable and knowledgeable support.
SA
Sultan A.
Jul 29, 2025
RFP Template and Official Document Creation
It is with great pleasure that I recommend Mr. Vadym, who recently served as a Business Analyst for our project, focusing on the definition of our Request for Proposal (RFP) and comprehensive Use Cases documentation.
During his engagement, Mr. Vadym consistently demonstrated exceptional skill and dedication. His ability to thoroughly understand our complex business requirements and translate them into clear, concise, and actionable RFP and Use Cases documentations.
Wishing him all the best
During his engagement, Mr. Vadym consistently demonstrated exceptional skill and dedication. His ability to thoroughly understand our complex business requirements and translate them into clear, concise, and actionable RFP and Use Cases documentations.
Wishing him all the best
JF
Josh F.
Jul 4, 2025
User Documentation for Dell Micro Desktop Removal and Lenovo M70q Installation
Vadym did a great job communication, meeting deadlines, and being professional.
RB
Rahim B.
Jun 23, 2025
30 min consultation
Thanks for the detailed review of my questions. Highly recommend Vadym to anyone considering implementation of new software in their company.
About Vadym
LIMS, LIS, ELN | GxP, GMP, CFR, EU Annex | R&D | CSV, Validation
100%
Job Success
Kyiv, Ukraine - 5:10 am local time
📋 Focus on regulated environments (GAMP 5, GxP, CFR Part 11, EU Annex 11, ISO 13485):
🔹 Validation-aligned documentation across medical, pharma, biotech, and R&D labs.
🔹 Traceable workflow steps and sign-off design for QMS systems.
🔹 Privacy, data integrity (ALCOA+), DPIA/record-keeping, breach traceability, and audit trails aligned with hybrid cloud systems.
🧩 Validation & Quality Governance:
🔹 Development of Computerized System Validation (CSV) documentation packages for GxP-regulated SaaS and laboratory systems, covering Validation Plans, Test Protocols (IQ/OQ/PQ/DQ), Traceability Matrices, and Validation Summary Reports.
🔹 Creation and maintenance of Validation Master Plans (VMPs) defining validation scope, organizational roles, lifecycle strategy, and change-control governance across systems or sites.
🔹 Implementation of Quality Management Systems (QMS) aligned with ISO 9001, ISO 13485, and 21 CFR Part 11, including document control, CAPA, and audit readiness.
🔹 Application of Quality Risk Management (QRM) methodologies (per ISO 14971, GAMP 5) to evaluate and mitigate data integrity and system risks throughout validation and operation.
🔹 Integration of QRM within the QMS and CSV within the VMP, ensuring traceable, risk-based validation consistent with GxP and data-integrity principles.
🔹 Support for regulatory inspections and supplier audits, ensuring that validation evidence and QMS documentation demonstrate continuous control and compliance.
🧪 Pharma, MedTech & R&D Focus:
🔹 Regulatory compliance assessment and validation documentation aligned with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP standards (GMP, GDP, GLP, GCP). URS/FS/DS, DQ/IQ/OQ/PQ, traceability, validation, protocols
🔹 Compliance & risk management for EHR, EMR, AI diagnostics, medical IoT, biotech software, and electronic lab systems (LIMS/LIS/ELN)
🔹 Structured documentation for regulated health platforms (FHIR, HL7), lab data integrity (ALCOA+), and audit trails
🔹 Traceable R&D workflows and design validation aligned with QMS and regulatory frameworks
🚀 What you get:
📌 Support SaaS, MedTech, and regulated industries in achieving compliance and regulatory readiness.
📌 Define, document, and optimize workflows for efficiency & compliance.
📌 Aligned tech teams, QA, and product with clear requirements and visualizations.
📌 Reduce technical debt and scope creep through structured documentation and clear boundaries between features, data, UI/UX, and integrations.
📌 Professional documentation you can show to investors, accelerator programs, or tech vendors to build trust.
📌 A long-term roadmapping stack that grows with your business.
📌 Define what MVP vs. later phase is so you avoid unnecessary development costs.
📌 Available for both hourly and fixed-price projects based on scope and complexity.
🌐 Industry Expertise:
🔷 Healthcare, MedTech & R&D IT – Compliance & risk management for EHR, EMR, AI diagnostics, medical IoT, biotech software, electronic lab systems (LIMS/LIS), and regulated digital health platforms (FHIR, HL7, GxP (GAMP, GMP, GDP, GCP, GLP), CFR Part 11, EU Annex 11, ICH Q9). and FDA 510(k) / 21 CFR Part 807 Subpart E. Validation, documentation, and risk management for regulated software and systems.
🔷 Enterprise IT & SaaS – Architecture & compliance for multi-tenant SaaS, ERP modernization, and cloud transformation.
🔷 Industrial Automation & Robotics – IT architecture for secure industrial systems, Operational Technology (OT) Security, and AI-powered robotics.
🔷 IT Governance – Ensuring IT compliance with risk-driven architecture strategies.
🔷 Digital Transformation & Cloud Strategy – Modernizing legacy IT systems, ERP migrations, and governance for large-scale cloud solutions.
🗸 Adherence to BABOK, DMBOK, SDLC, ISTBQ, INVEST/SMART, 12-factor, MACH, AWS, and GCP standards and best practices.
📚 Documentation & Business Analysis Services:
- 📝 SRS/SRD/BRD/FRD/NFRD/BPR/TDD/SAD/SDD/RFI/RFQ preparation,
- 📝 FHIR resource modeling, HL7 mapping, and interoperability documentation for EHR integrations
- 🔄 BPMN process modeling,
- 🔗API documentation,
- 🔀 Process diagrams, ERDs, DFDs, UMLs, conceptual models, and data dictionaries,
- 📌 Strategy analysis,
- 🛠️ Requirements analysis and design definition,
- 📈 Solution evaluation.
Steps for completing your project
After purchasing the project, send requirements so Vadym can start the project.
Delivery time starts when Vadym receives requirements from you.
Vadym works on your project following the steps below.
Revisions may occur after the delivery date.
Intake & Questionnaire Review
You complete a short pre-assessment form based on ISO/IEC 27001 Clauses 4–10. I review your submitted materials to understand your current compliance maturity.
Gap & Risk Mapping
I map each clause and Annex A control against evidence provided, flag critical gaps, and assess risk severity. You’ll receive a clause-by-clause trace of findings.