Vadym C.

Business Analysis, Technical Writing & Software Consulting for SaaS, enterprise applications, healthcare, MedTech, R&D, and regulated software systems. Specialization in requirements engineering, functional and systems analysis, technical documentation, quality systems, and software lifecycle documentation. Translating complex business, technical, and regulatory requirements into structured specifications, actionable procedures, and practical recommendations. 📋 Business Analysis & Technical Writing 🔹 Requirements elicitation, decomposition, gap analysis, and functional/non-functional specifications. 🔹 BRD, SRS, FRS, URS, use cases, user stories, acceptance criteria, and traceability matrices. 🔹 Business process analysis, AS-IS / TO-BE modeling, workflow mapping, and process improvement. 🔹 Definition of scope, business rules, constraints, dependencies, exceptions, and system behavior. 🔹 Identification and clarification of ambiguous, incomplete, inconsistent, or conflicting requirements. 🔹 SOPs, policies, work instructions, process manuals, operational guidelines, and technical specifications. 🔹 Software user guides, administrator manuals, implementation guides, knowledge bases, and release documentation. 🔹 Documentation restructuring, standardization, version control, change tracking, review workflows, and approval records. ⚙️ Software Consulting & Functional Analysis 🔹 Functional decomposition of SaaS and enterprise software, modules, workflows, and interconnected processes. 🔹 Assessment of business logic, permissions, data relationships, integrations, and cross-module dependencies. 🔹 Identification of functional gaps, edge cases, exception handling, and change impacts. 🔹 Evaluation of system behavior against documented business requirements and intended use. 🔹 Recommendations for requirements quality, workflow consistency, documentation architecture, and development/QA handoffs. 🛡️ ISO 27001 & Quality Systems Documentation 🔹 ISO/IEC 27001-aligned information security policies, SOPs, procedures, and control documentation. 🔹 Documentation supporting ISMS governance, responsibilities, approvals, and controlled processes. 🔹 Documentation gap analysis, evidence traceability, and quality reviews against defined controls. 🔹 Process documentation for access management, change control, incident handling, and supplier management. 🔹 Controlled documentation, revision histories, review workflows, and audit-supporting records. 🔬 GxP & Computerized System Validation (CSV) 🔹 Validation documentation aligned with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, ICH Q9, and ALCOA+. 🔹 Validation plans, URS/FRS, FMEA, DQ/IQ/OQ/PQ, RTM, and Validation Summary Reports. 🔹 OQ test execution, evidence collection, results documentation, and deviation reporting. 🔹 Risk-based traceability, change impact assessment, document control, version management, and release documentation. 🔹 Documentation of audit trails, electronic records/signatures, access controls, and regulated workflows. 🔍 Process Modeling & Documentation Management 🔹 BPMN, UML, use cases, data flow diagrams (DFD), and entity-relationship diagrams (ERD). 🔹 Business workflow mapping, operational process documentation, and improvement recommendations. 🔹 Requirements and document traceability, change control, and revision management. 🔹 Stakeholder interviews, technical clarification, and documentation review cycles. 🏢 Industry Expertise 🔹 Healthcare, MedTech & R&D IT — EHR/EMR, LIMS/LIS/ELN, and regulated platforms. 🔹 Enterprise IT & SaaS — Multi-tenant SaaS, enterprise applications, and cloud software. 🔹 Quality & Regulated Environments — ISO 27001, GxP/CSV, QMS documentation, and data integrity. 🔹 Industrial & Technical Systems — Operational workflows, system interfaces, and technical specifications. 🚀 Typical Deliverables 📌 BRD, SRS, FRS, URS, non-functional requirements, and traceability matrices. 📌 SOPs, policies, work instructions, process manuals, and technical/user guides. 📌 ISO 27001-aligned procedures, control documentation, and quality records. 📌 CSV protocols, FMEA, OQ evidence, deviation logs, and validation reports. 📌 Process maps, functional workflows, acceptance criteria, and use cases. 📌 Functional gap assessments, documentation reviews, and document control frameworks.