Business Requirements Document
HelixOps Quality Management System - GxP Validation Documentation
1. Introduction #
Purpose
This Business Requirement Document (BRD), also serving as the User Requirements Specification (URS), defines the business and regulatory requirements for the HelixOps enterprise SaaS platform. This document establishes what the system must accomplish from a business perspective, forming the foundation for subsequent Functional and Design Specifications.
Scope
Intended Audience
- • Business Owners and Stakeholders
- • Quality Assurance Personnel
- • System Developers and Architects
- • Validation Team and Regulatory Auditors
Traceability
This document traces to PRD-HELIX-001 and forms the basis for FS-HELIX-001.
2. General System Requirements #
The following requirements apply to the HelixOps system as a whole and establish the foundation for all module-specific requirements.
System-Wide Business Requirements
Req ID | Description | Priority | GxP | Source |
|---|---|---|---|---|
| BUS-REQ-001 | Unified web-based interface accessible via modern browsers (Chrome, Firefox, Safari, Edge) | Must Have | Yes | PRD Section 6.1 |
| BUS-REQ-002 | Authenticate users via OpenID Connect (Replit Auth) integration | Must Have | Yes | PRD Section 9.1 |
| BUS-REQ-003 | Role-based access control (RBAC) with Admin, Manager, and Viewer roles | Must Have | Yes | PRD Section 4.1 |
| BUS-REQ-004 | 15-minute idle session timeout for all authenticated users | Must Have | Yes | PRD Section 6.3 |
| BUS-REQ-005 | Password complexity: min 12 chars with alphanumeric and special characters | Must Have | Yes | PRD Section 6.3 |
| BUS-REQ-006 | Support concurrent access by minimum 100 users without degradation | Must Have | Yes | PRD Section 6.1 |
| BUS-REQ-007 | Comprehensive audit trail of all GxP-impacting actions (CRUD, login/logout, export/import) | Must Have | Yes | PRD Section 10.1 |
| BUS-REQ-008 | Retain audit trail records for minimum 10 years | Must Have | Yes | PRD Section 6.2 |
| BUS-REQ-009 | Implement ALCOA+ principles for all GxP-critical data | Must Have | Yes | PRD Section 10.2 |
3. GRC Module Requirements #
The Governance, Risk & Compliance module provides enterprise risk management, controls management, and compliance framework mapping capabilities.
Enterprise risk identification, assessment, and treatment
Control design, implementation, and effectiveness monitoring
Multi-framework compliance mapping and tracking
GRC Module Requirements
Req ID | Description | Priority | GxP | Source |
|---|---|---|---|---|
| BUS-REQ-100 | Create, view, update, and close enterprise risk records | Must Have | Yes | PRD Section 2.3 |
| BUS-REQ-101 | Classify risks: Strategic, Operational, Financial, Compliance, Cybersecurity | Must Have | Yes | Replit.md |
| BUS-REQ-102 | Support risk statuses: Open, Mitigated, and Closed | Must Have | Yes | Replit.md |
| BUS-REQ-103 | Risk treatment options: Accept, Avoid, Mitigate, and Transfer | Must Have | Yes | Replit.md |
| BUS-REQ-104 | Calculate risk scores using 5x5 matrix (Likelihood × Impact) | Must Have | Yes | Replit.md |
| BUS-REQ-110 | Create, view, update, and close control records | Must Have | Yes | PRD Section 2.3 |
| BUS-REQ-111 | Assign controls to one or more risks | Must Have | Yes | Replit.md |
| BUS-REQ-120 | Map compliance requirements to multiple regulatory frameworks | Must Have | Yes | Replit.md |
4. Privacy Module Requirements #
The Privacy module provides comprehensive GDPR compliance capabilities including DPIA management, Records of Processing Activities, and Data Subject Access Request handling.
Privacy Module Requirements
Req ID | Description | Priority | GxP | Source |
|---|---|---|---|---|
| BUS-REQ-200 | Create, view, update, and archive DPIA records | Must Have | Yes | PRD Section 2.3 |
| BUS-REQ-201 | Execute DPIA workflow with configurable approval stages | Must Have | Yes | Replit.md |
| BUS-REQ-210 | Create, view, update, and archive processing activity records (ROPA) | Must Have | Yes | PRD Section 2.3 |
| BUS-REQ-220 | Receive, track, and respond to data subject access requests (DSAR) | Must Have | Yes | PRD Section 2.3 |
| BUS-REQ-221 | Track DSAR response deadlines with configurable SLAs | Must Have | Yes | GDPR Art. 12 |
5. FinOps Module Requirements #
The Financial Operations module provides multi-currency AR/AP management with bank feed integration (ISO 20022) and reconciliation workflows.
Key Capabilities
- • Invoice generation and tracking
- • Payment receipt recording
- • Aging reports and collections
- • Bill management and approval
- • Payment scheduling
- • Vendor management
- • ISO 20022 bank feed import
- • Automated transaction matching
- • Reconciliation workflows
- • EUR, USD, GBP, CHF support
- • Exchange rate management
- • Currency conversion tracking
6. Action Center Requirements #
The Action Center provides centralized task management and approval workflows across all HelixOps modules.
Unified Task Management
- • Centralized view of all pending tasks and approvals
- • Configurable approval workflows with multi-stage support
- • SLA tracking with automated escalation
- • Role-based task assignment and delegation
7. Traceability Matrix #
The following matrix shows the traceability between PRD requirements and BRD requirements.
Explore the full requirements traceability chain across all validation documents
Document Approval
Electronic signatures are considered equivalent to handwritten signatures in accordance with 21 CFR Part 11 requirements.