Product Requirements Document
HelixOps Quality Management System - GxP Validation Documentation
1. Executive Summary #
HelixOps is an enterprise-grade Software as a Service (SaaS) platform designed to serve as the internal operations management system for the PharmaLedger Association (PLA). The platform unifies critical business functions including:
- Enterprise Risk Management (ERM) - Comprehensive risk identification, assessment, and mitigation
- Governance Risk and Compliance (GRC) - Controls management and compliance framework mapping
- Privacy Operations - GDPR compliance, DPIA, DSAR, and consent management
- Financial Operations - Multi-currency AR/AP ledger with bank feed integration
Strategic Positioning
HelixOps operates as an "operating system for trust," democratizing access to enterprise-grade operational capabilities that have traditionally been exclusive to large pharmaceutical organizations with costly legacy systems.
2. Product Vision & Scope #
Vision Statement
To provide PharmaLedger Association with a unified, enterprise-grade SaaS platform that enables comprehensive operational management across risk, compliance, privacy, and financial domains while maintaining the highest standards of pharmaceutical regulatory compliance, data integrity, and audit readiness.
Strategic Objectives
21 CFR Part 11, EU Annex 11, GDPR, SOC 2, ISO 27001
ALCOA+ principles embedded throughout all functions
Continuous audit-ready state with complete traceability
Support growth from current baseline to expanded operations
Scope Boundaries
- • GRC Module (Risk, Controls, Compliance)
- • Privacy Module (DPIA, ROPA, DSAR)
- • Financial Operations Module
- • Action Center & Workflows
- • Administration & RBAC
- • Audit Trail & E-Signatures
- • EDMS beyond policy references
- • LIMS functionality
- • MES capabilities
- • Clinical trial management
- • Direct patient data processing
3. Success Metrics #
| Category | Metric | Target | Frequency |
|---|---|---|---|
| Compliance | Audit Trail Completeness | 100% GxP actions logged | Continuous |
| Data Integrity Deviation Rate | 0 ALCOA+ violations | Monthly | |
| Regulatory Inspection Readiness | 100% docs within 24 hours | Quarterly | |
| 21 CFR Part 11 Compliance | 100% | Quarterly | |
| Performance | System Availability | ≥99.5% uptime | Monthly |
| UI Response Time | <2 seconds (P95) | Daily | |
| API Response Time | <500ms (P95) | Daily |
4. User Personas #
Manages enterprise risk assessments, controls, and compliance frameworks. Needs risk heat maps and automated compliance mapping.
Oversees privacy compliance, GDPR adherence, DPIA execution. Needs DPIA workflows, DSAR tracking, and consent management.
Manages financial operations including AR/AP, reconciliation, and reporting. Needs multi-currency support and bank feed integration.
Manages user access, system configuration, and audit logs. Needs RBAC management and comprehensive audit capabilities.
5. Product Requirements #
High-Level Product Requirements
Requirement ID | Description | Priority | Category |
|---|---|---|---|
| PRD-REQ-001 | Unified SaaS platform for GRC, Privacy, and Financial Operations | Critical | Core Platform |
| PRD-REQ-002 | Enterprise Risk Management with heat maps and assessments | Critical | GRC |
| PRD-REQ-003 | Compliance framework mapping (SOC 2, ISO 27001, GDPR) | Critical | GRC |
| PRD-REQ-004 | Privacy Operations with DPIA, ROPA, and DSAR management | High | Privacy |
| PRD-REQ-005 | Financial Operations with multi-currency AR/AP ledger | High | Finance |
| PRD-REQ-006 | Action Center for task management and approvals | High | Workflow |
| PRD-REQ-007 | Role-based access control (RBAC) with audit logging | Critical | Security |
| PRD-REQ-008 | Electronic signatures per 21 CFR Part 11 | Critical | Compliance |
| PRD-REQ-009 | Complete audit trail with ALCOA+ compliance | Critical | Compliance |
| PRD-REQ-010 | Member 360 Registry with helpdesk integration | Medium | Member Management |
6. Compliance Requirements #
21 21 CFR Part 11 Compliance
- • Electronic records must be trustworthy, reliable, and equivalent to paper
- • Electronic signatures must be unique, verifiable, and linked to records
- • Audit trails must capture all record modifications with timestamps
- • System access must be limited to authorized individuals
EU EU Annex 11 Compliance
- • Risk management applied throughout computerized system lifecycle
- • Validation documentation maintained for all GxP-impacting functions
- • Data integrity controls for accuracy, completeness, and consistency
- • Business continuity with appropriate backup and recovery procedures
A+ ALCOA+ Data Integrity
7. Regulatory Frameworks #
Document Approval
Electronic signatures are considered equivalent to handwritten signatures in accordance with 21 CFR Part 11 requirements.