Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
A scalable, real-time, collaborative, out-of-the box solution for CROs, Life Science Consultants and Industry Stakeholders. Built in an Audit Ready Compliant Cloud environment (ARCC). All 21 CFR Part 11 requirements are met. GxP audit ready. Pre-configured Departmental. Communications with internal and external stakeholder. Secure data integration between remote teams. Collaboration in review and approval. Turn access on/off according to need (EX: auditors), reducing audit prep time from days to hours. Preconfigured to eTMF Reference models & EDM. Intelligent content management tools can improve workflows. Improve document management with real-time collaboration, automatic indexing and co-authoring. Pre-configured, validated system that manages documents and data electronically in accordance with eCTD mandates.
Description
ZipQuality offers a software-driven service designed to aid medical device manufacturers in launching innovative products. Our collaborative platform adeptly manages swift design modifications for agile teams while upholding regulatory standards. With a pre-configured system that incorporates processes and tools, there’s no necessity to modify your existing quality system. The integrated platform efficiently accommodates rapid design iterations for product documentation. Our team of seasoned consultants supports your team throughout the entire process. Built on the robust ENOVIA platform, our comprehensive, scalable software tools are tailored to meet your needs. This integrated solution allows for quick design adjustments while ensuring that product documentation and data remain synchronized and that all records are maintained in a state ready for audits. We cover essential areas such as product, hardware, and software requirements. Our expertise extends to the complexities of software-heavy medical devices. The ZipQuality framework is founded on a structured documentation approach that enhances systems engineering, promotes effective risk management, and ensures transparent traceability, making it an invaluable asset for any medical device company. Additionally, our commitment to continuous improvement means we regularly update our service offerings to align with industry advancements.
API Access
Has API
No
API Access
Has API
No
Integrations
Crow Canyon Contract Management
No
Pricing Details
Per user, Per month
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Court Square Group
Founded
1995
Country
United States
Website
www.regdocs365.com
Vendor Details
Company Name
Consensia
Country
United States
Website
consensiainc.com/zipquality/
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Yes
Document Management
Yes
Electronic Data Capture
Yes
Enrollment Management
No
HIPAA Compliant
Yes
Monitoring
No
Patient Database
No
Recruiting Management
No
Scheduling
No
Study Planning
No
Document Control
Archiving & Retention
No
Automated Routing
No
Change Management
No
Compliance Management
No
Electronic Signature
No
Escalation Management
No
Periodic Review
No
Version Control
No
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
No
Compliance Tracking
No
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
No
Product Features
Quality Management
Audit Management
No
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
No
Training Management
No