Deviation, OOS, and Investigation Management
Record, assess, and investigate deviations and out-of-specification events with a closed-loop, automated workflow. Novatek eliminates “missing in action” deviations, speeds up impact assessment, and integrates with your existing ERP/MES systems — reducing deviation cycle time and cost of quality without custom software work.
Customer Complaint Management
Record, track, and trend customer complaints and adverse events to GMP standards, with one system for complaint handling and adverse event reporting. Novatek centralizes complaint intake from call centers, distributors, sales, and quality teams, and integrates with ERP systems like SAP, JDE, and Oracle for accurate, streamlined reporting.
Audit Management
Plan, execute, and track the full audit lifecycle — scheduling, preparation, findings, corrective actions — in one system, replacing the disconnected tools most companies use across internal, supplier, and regulatory audits. Novatek’s Audit Manager standardizes audits with online questionnaires, automated scoring, and offline result capture, and produces audit reports directly from the system. Novatek supports any audit type, including:
- GMP/GLP/GCP
- Business Conduct Standards
- Clinical Support Audits
- Compliance
- Computer Related System Validation Audits
- Contractor Compliance Assessment
- Internal Quality Audits
- Risk Assessments
- Internal Controls
- Contractor / Supplier / Vendor
- Third-party (FDA, ISO)
- Site Audits
- Pre-Clinical Studies
- Processes
- Internal Facility Projects
- Method Validation Audits
- EH&S Audits
Change Control
Manage every type of change — equipment, process, materials, documents, computer systems, suppliers, and more — through one centralized, flexible system. Novatek routes each change through the right impact assessment, review, and approval steps automatically based on its type and risk, and integrates with ERP and document management systems to keep records connected. Novatek manages all types of change, including:
- Equipment
- Process
- Batch/Material/Part
- Documents (SOPs, Protocols)
- Computer Systems
- Supplier changes
- Emergency Changes
- Labeling and Packaging
- EH&S Changes
- Utilities
- Validation
Corrective Action and Preventive Action (CAPA)
Automate and centralize your CAPA program — from logging events and root-cause investigation to tracking actions and verifying effectiveness. Novatek connects investigations across sources, gives investigators personalized dashboards, and escalates overdue items automatically, with built-in reporting for quality trending.
Training Management
Automate training assignments, tracking, and compliance in the same system as your other quality processes. Novatek defines curricula per role, auto-schedules training for new hires or after SOP/process changes, escalates overdue training, and links requirements directly to CAPA and change control records.
Document Management
Control document versions, access, and change history for SOPs, batch records, COAs, validation documentation, and more — all from one system, without giving up best-in-class document management capability. Applications include:
- SOPs, policies, work instructions
- Batch records
- Certificates of Analysis (COAs)
- Regulatory submissions
- Regulatory correspondence
- CAPA objective evidence
- Documentation related to change control
- Validation documentation
- Manuals, instructions
- Employee training and qualification records
- Project documentation
- Investigation documents, photographs, etc.
- Contractor batch records, quality records
- Audit reports and follow-ups