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features
design
support

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Write a Review

Description

Ensure adherence to regulations while streamlining your auditing processes with tools specifically tailored to fit your workflow. Utilize workpaper automation that effortlessly generates evidence directly in your web browser, alongside smart cross-referencing that provides relevant supporting documents. Accomplish more with reduced stress through a recommendation platform designed for both auditors and auditees, allowing for simple updates submission, historical tracking via an integrated timeline, and result analysis through ready-made dashboards and reports. Effortlessly monitor the time dedicated to various audit projects and acquire immediate visibility into the status of audits and the distribution of resources. This comprehensive approach not only enhances efficiency but also fosters collaboration throughout the auditing process.

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.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Crow Canyon Contract Management No 

Integrations

Crow Canyon Contract Management Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

Per user, Per month
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 No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support No 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Missionmark

Country

United States

Website

www.missionmark.com

Vendor Details

Company Name

Court Square Group

Founded

1995

Country

United States

Website

www.regdocs365.com

Product Features

Audit

Alerts / Notifications No 
Audit Planning No 
Compliance Management No 
Dashboard No 
Exceptions Management No 
Forms Management No 
Issue Management No 
Mobile Access No 
Multi-Year Planning No 
Risk Assessment No 
Workflow Management No 

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 

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