Controlled Documents (testcompany2)
Manage compliance records and document lifecycles.
Filter by Status
| ID / Number | Document Title | Version | Status | Last Modified | |
|---|---|---|---|---|---|
PLAN-001 | Post-Market Surveillance Plan 2026 | 1.0 | APPROVED | 3/10/2026 | |
TP-002 | Technical File: HbA1c Analyzer HA-1000 | 2.0 | EFFECTIVE | 3/10/2026 | |
TP-001 | Technical File: Rapid Glucose Test Kit RGT-500 | 3.0 | EFFECTIVE | 3/10/2026 | |
VAL-002 | eQMS Platform Validation Protocol | 1.0 | UNDER_REVIEW | 3/10/2026 | |
VAL-001 | Automated Analyzer Software Validation Report | 1.0 | EFFECTIVE | 3/10/2026 | |
WI-LAB-003 | Environmental Monitoring SOP | 1.0 | DRAFT | 3/10/2026 | |
WI-LAB-002 | Stability Study Procedure | 2.1 | EFFECTIVE | 3/10/2026 | |
WI-LAB-001 | Lot Release Testing Protocol | 6.0 | EFFECTIVE | 3/10/2026 | |
SOP-RA-001 | Risk Management (ISO 14971 + IVDR) | 2.5 | EFFECTIVE | 3/10/2026 | |
SOP-QA-003 | Management Review Procedure | 1.0 | EFFECTIVE | 3/10/2026 | |
SOP-QA-002 | Complaint Handling & Vigilance Reporting | 3.0 | APPROVED | 3/10/2026 | |
SOP-QA-001 | CAPA & Nonconformance Procedure | 2.1 | EFFECTIVE | 3/10/2026 | |
SOP-MFG-002 | Calibration & Maintenance of Lab Equipment | 2.4 | EFFECTIVE | 3/10/2026 | |
SOP-MFG-001 | Reagent Manufacturing Process Control | 3.2 | EFFECTIVE | 3/10/2026 | |
SOP-PD-003 | Clinical Performance Evaluation | 1.3 | UNDER_REVIEW | 3/10/2026 | |
SOP-PD-002 | Software Development Lifecycle (IEC 62304) | 2.0 | EFFECTIVE | 3/10/2026 | |
SOP-PD-001 | IVD Product Development Lifecycle | 4.1 | EFFECTIVE | 3/10/2026 | |
SOP-DMS-002 | Electronic Signature Policy | 1.2 | EFFECTIVE | 3/10/2026 | |
SOP-DMS-001 | Document & Records Management | 3.0 | EFFECTIVE | 3/10/2026 | |
SOP-101 | Manufacturing SOP - Test Company Two (Pharma Tech) | 1.0 | UNDER_REVIEW | 3/10/2026 | |
QM-001 | Quality Manual - Test Company Two (Pharma Tech) | 1.0 | APPROVED | 3/10/2026 |