Quality Suite
Full Features
Document Management
| Document life cycle and version control |
| Pre-configured inventory for SOPs, Work Instructions, Quality Manuals, etc. |
| User roles include authors, reviewers, approvers, signatories and recipients |
| User rights and confidentiality management |
| Integrated PDF rendering and viewing, controlled PDF print, copy and paste |
| Unlimited document size |
| Supports all file formats (.pdf, .docx, .xlsx, .pptx, .jpg, .xml, .avi, etc.) |
Workflow Management
| Full featured Quality Management System (QMS) |
| Pre-configured inventory for Deviations, Nonconformances, CAPAs, Complaints, Change controls |
| Manage audits, inspections and follow-up activities |
| Email notifications and alerts |
| Dynamic and configurable forms |
| Sub-processes and validation steps |
| Multi-site management capabilities |
Training Management
| Create, schedule and track online curricula |
| Develop specialized training modules |
| Easily manage employee on-boarding |
| Monitor skill inventories by person, group or role |
| Track training progress in real time |
| Implement configurable online assessments to measure proficiency |
Compliance
| Unique ID reference code generator |
| Two-step electronic signature verification |
| Full audit trail |
| ISO 9000:2005, ISO 9000:2009, GxP, and FDA 21 CFR Part 11 compliant |
| Validation toolkit for IQ, OQ and PQ verification |
Metrics
| Automatic periodic reports |
| Real time dashboards |
| Statistics and other dynamic quality indicators |
| Business Intelligence and datamart capabilities |
Search
| Solr search engine (use by Google) |
| Full text search on document content and metadata |
| Advanced search form based on multi-criteria |
| Quick search tool |
| Configurable and sortable search results display and views |
Mobility
| Apple iPad app for document management |
| View and sign your document from everywhere |
| Offline synchronization |
| Available cloud-based deployment |
| Full web-based solution is browser independent |
| Local language capability is ideal for multi-site deployment |
Information system integration
| Cloud-based or on-premises deployment options |
| Fully configurable, turn-key solution requires zero programming |
| Highly scalable architecture |
| REST API to connect to other enterprise systems (CRM, ERP, PLM, etc.) |
| Email and scanner connectivity |