EVOLV
In the quest of meeting demands of compliance procedures and regulatory guidelines, organizations often encounters increasing paperwork, workload, and errors. This mounting pressure leads to poor quality delivery, resulting in business losses and dissatisfaction on dismal performances.
EVOLV – A 21 CFR Part 11 Compliant System is a holistic quality management system that provides a single platform to track all quality events of your organization. It links all aspects of Quality Management processes by tracking and aligning each step through proactive and intuitive notifications, alerts and escalations. Any non-compliance is noticed and rectified for quick redressal.
This simple and easy-to-use platform allow organizations to meet their quality program expectations as well as conform to certification systems and high customer standards. While the impediments in the business process are taken care by EVOLV, organizations can now focus on what really matters - Growth.
Electronic Documents
A powerful time saving tool for document management for quality procedures and compliance.
Paperless Submissions and Approvals.
Access 1000s of Documents from anywhere.
Electronic Signatures for everyone.
View and print documents with labels.
Download past versions.
Quality Events
A single platform to keep your all quality events organized and managed for optimum results.
Manage Deviations, OOS, OOT, incidents and market complaints.
Track change controls, CAPA.
Add and Track task until closure.
Manage Documents for all quality events.
Configurable workflows for approvals.
Customizable document download formats.
Training Compliance Management
A self learning tool, triggering automatic training needs, materials, and questionnaires.
Manage position based training matrix at all levels.
Manage instructor – led and self service trainings.
Pre-loaded system generated training assignments.
Generate automated attendance sheets.
Create ad-hoc training assignments as per needs.
Configurable workflows for approvals.
Regulatory Compliance
Enhanced compliance with 21 CFR 11 and other regulatory requirements
Justifications for every Action.
Role Based Permissions for All Actions.
eSignature Agreements in User Profiles.
Data Back up Services including Audit Trails.
Print only on Authorized Printers.
Never download documents to the system.
Quality Trend Analysis
Generate trend reports for all quality events for decision making and also for annual reporting
Generate trends based on Event Type
Generate trend based on Timeline
Generate trends based on process changes
Real-time visibility in trends for immediate action
Download reports in presentable formats.
Vendor Qualification
Automated notification enabled for generating an exhaustive and current vendor list and their qualifications.
Manage master data for materials and suppliers
Track entire life cycle of qualification process
Add all VQ documents to the list item
Configurable workflows for approvals
Link to electronic documents