Product Overview
What is Clinevo OneQMS
Clinevo OneQMS is a cloud-based quality management system that enables organizations to manage quality and compliance processes digitally. OneQMS enables organizations to manage Documents, Training, Change, CAPA, Audits in one place.
This software is a combination of 3 platforms, Document Management (DMS), Training Management, and Quality Management Systems (QMS) which can save up to 75% of the cost that you might be spending.
Below are the unique advantages
1. ONE-STOP SOLUTION FOR QUALITY MANAGEMENT
2. EASY INTEGRATION WITHIN MODULES
3. DYNAMIC WORKFLOWS
4. ANYTIME AND ANYWHERE
5. REGULATORY INSPECTION READY
6. REAL-TIME MONITORING, DASHBOARDS, AND REPORTING
7. COST EFFECTIVE & HIGH PERFORMING
8. FASTER USER ADOPTION
9. MULTI-LEVEL REPORT GENERATION
10. CUSTOMIZABLE REMINDERS AND NOTIFICATION
11. MAPPING INTER-DEPENDENCIES
Specifications
One Quality Management System (OneQMS)
Clinevo OneQMS is a cloud-based quality management system enables organizations to manage quality and compliance process digitally. OneQMS enables organizations to manage documents, training, Change, CAPA, audits in one place.
ONE QUALITY MANAGEMENT SYSTEM
Clinevo One Quality Management System (QMS) is an one interactive platform to manage all quality and compliance process of an organization.
DYNAMIC WORKFLOWS
Clinevo One Quality Management System (QMS) is the best QMS which provides easily configurable workflows to meet any complex organization requirements for managing CAPA, CR, Deviations and Audits.
INTEGRATED TRAINING MANAGEMENT SYSTEM
Clinevo One Quality Management System (QMS) ships with inbuilt Training Management System to efficiently manage organization’s training processes.
INTEGRATED DOCUMENT MANAGEMENT SYSTEM
Clinevo One Quality Management System (QMS) ships with inbuilt Document Management System to efficiently manage organization’s SOPs, Documents, Work instructions, etc.
ANYTIME, ANYWHERE & ANY DEVICE
Clinevo One Quality Management System (QMS) is the best QMS which can be accessed with basic internet / intranet using IE, Chrome and Firefox browsers
REGULATORY INSPECTION READY
Clinevo One Quality Management System (QMS) Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.
REAL TIME MONITORING, DASHBOARDS AND REPORTING
Clinevo One Quality Management System (QMS) is the best QMS which provides powerful and actionable dashboards and reports for real time monitoring and tracking of quality and compliance.
COST EFFECTIVE & HIGH PERFORMING
Clinevo One Quality Management System (QMS) is a the best QMS software which comes with transparent optimized pricing. Clinevo One Quality Management System (QMS) is one of the best QMS built on a Committed Infrastructure, hosting, training, business process and 24/7 Application support.
FASTER USER ADOPTION
Business, Quality, IT team and others can be trained on the Clinevo One Quality Management System (QMS) within few hours.
Clinevo Document Management System (DMS)
Clinevo Document Management System is a web based easy-to-use document management system to maintain, review, approve, manage, publish your organization's documents electronically (including SOPs, work instructions, Contracts, Vendor documents, etc) in one place.
Clinevo Document Repository meets all the electronic document and regulatory guidelines including:
Version control
Redacting / Masking
Document lifecycle and workflows
Expiration management
Security and access control,
Change controls,
Audit trails, and
System validation.
LIVE TRACKING & STATUS
Based on the documents plan, the system tracks the status of the documents & monitors the verification/approval statuses of the documents
CONFIGURABLE ORGANIZATION STRUCTURE
Configurable classification structure for organizations to manage their Organization Specific or Project Specific Structures for reusability
DOCUMENTS PLANNING & DUE DATES SETUP
The system allows companies to create a Plan along with the due date for the documents at Organization or Project level
DOCUMENT LIFECYCLE AND VERSION CONTROL
Robust Documents Lifecycle with Author, Review and eSign/Approval workflow. Automated version controlling with robust Check-in and Check-out functionality
ADVANCED ANALYTICS
Gain powerful and actionable insights Advanced Analytics to track Completeness, Quality, Timeliness and compliance of the documents.
BULK / QUICK UPLOAD
The system allows users to upload hundreds of documents in one go with a simple drag and drop. Dynamic Indexing of documents
REDACTION OF INFORMATION
System provides options to redact sensitive information on the uploaded documents.
SHARING AND COLLABORATION
Allows a user to invite external parties to upload and work collaboratively on documents system in a controlled method
FASTER USER ADOPTION
Anyone can be trained on this system within few hours.
ANYTIME, ANYWHERE & ANY DEVICE
User friendly web application can be accessed with internet / intranet using IE, Chrome and Firefox browsers and on any device enables real-time site collaboration and document exchange
REGULATORY INSPECTION READY
Audit trail maintained for every operation fully compliant eSignatures for all stakeholders Complies with 21 CFR Part 11, ANNEX 11, GxP, GDPR.
EXPIRATION MANAGEMENT & NOTIFICATIONS
Expiration Management and document expiry alerts Configurable email and system notifications.
Training Management System / eLearn
Clinevo Training management system/eLearn is a cloud based, regulatory compliant training management system for managing and maintaining training records digitally.
Clinevo TMS helps Organizations to Create, Assign, Assess, Track, Monitor and Report, Trainings seamlessly.
Trainer can create trainings and upload the training documents / videos / files
Trainer can assign the questions (evaluation) and answers and the passing score for the training
Trainer can assign the created trainings to set of participants or to certain user groups / users
Created trainings can be sent for review and approval before it is available for the trainees
Trainees gets notification and can access the training
Evaluation, Retraining, Training Certificates
Electronic Signatures
System shall have the capabilities to send reminders for the pending trainings
Dashboards and reports - organization level and project level training completion and compliance
Audit reports for training records - At individual trainee level, or at some specific training level, etc.
CTMS Integration - Trainings scheduled , tracked and managed in CTMS will be available for training
Integration with eTMF / DMS - Document published will be available in the Training mgmt. system.