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Schedule Interview NowMy name is Vadym C. and I have over 9 years of experience in the tech industry. I specialize in the following technologies: Business Analysis, User Stories, Requirements Specification, Software Documentation, Software Specifications, etc.. I hold a degree in . Some of the notable projects I’ve worked on include: Document-Only ISMS Structure for ISO/IEC 27001:2022 Compliance, 21 CFR Part 11 – Implementation Readiness, EU Annex 11 – Implementation Readiness, Medical EHR SaaS - Software Requirements Specification, Medical EHR SaaS - Standard Operating Procedures (SOPs), etc.. I am based in Kyiv, Ukraine. I've successfully completed 11 projects while developing at Softaims.
I employ a methodical and structured approach to solution development, prioritizing deep domain understanding before execution. I excel at systems analysis, creating precise technical specifications, and ensuring that the final solution perfectly maps to the complex business logic it is meant to serve.
My tenure at Softaims has reinforced the importance of careful planning and risk mitigation. I am skilled at breaking down massive, ambiguous problems into manageable, iterative development tasks, ensuring consistent progress and predictable delivery schedules.
I strive for clarity and simplicity in both my technical outputs and my communication. I believe that the most powerful solutions are often the simplest ones, and I am committed to finding those elegant answers for our clients.
Main technologies
9 years
8 Years
8 Years
4 Years
Potentially possible
SoftServe
Developed a complete document-only ISMS (Information Security Management System) structure aligned with ISO/IEC 27001:2022. The package includes all foundational policies, procedures, and plans required for certification preparation - such as scope definition, risk management, access control, vendor policy, and incident response. Tailored for teams seeking lean compliance onboarding without full system buildout.
Led the compliance readiness effort for a regulated LIMS platform, mapping 21 CFR Part 11 clauses to real system behaviours. Delivered a traceable clause-by-clause matrix with actual validation evidence, status indicators (✅/❌/⚠️), and auditor-facing objectives. Aligned with FDA validation expectations, including audit trail, e-signatures, and risk-based controls.
Developed an EU Annex 11 implementation matrix for a cloud-based medical SaaS product. Translated each clause into traceable test objectives and provided real validation artifacts from actual client engagements. Emphasized lifecycle validation, change control, and risk management in line with GAMP 5 and EMA audit practices.
This SRS covers the following product components in adherence to Agile, SDLC, INVEST/SMART, 12-factor, MACH, BABOK standards and best practices: - Business Requirements - Stakeholder Register - Functional Requirements - Non-Functional Requirements (NFRs) - Business Rules - User Stories - UI/UX Sitemap - Workflow Diagram / DFD / ERD / Infrastructure diagram - SWOT Analysis - Glossary - Data Dictionary
This document outlines the complete set of Standard Operating Procedures (SOPs) for the Medical EHR SaaS platform. The purpose of this SOP manual is to ensure standardized, secure, and compliant operations across all system roles, including Admins, Doctors, Nurses, Patients, Pharmacists, Developers, and Compliance Officers. These SOPs support regulatory requirements, system reliability, security, user management, and technical operations. Each SOP is structured as a Module, containing a clear objective, applicable scope, and detailed, step-by-step procedures for operational consistency.
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2011-01-01-2016-01-01