+
+

Related Products

  • ContractSafe
    319 Ratings
    Visit Website
  • LinkSquares
    724 Ratings
    Visit Website
  • Concord
    237 Ratings
    Visit Website
  • isoTracker Quality Management
    19 Ratings
    Visit Website
  • Titan
    376 Ratings
    Visit Website
  • Deel
    15,850 Ratings
    Visit Website
  • Filevine
    576 Ratings
    Visit Website
  • R3 Contract Management for GovCon
    1 Rating
    Visit Website
  • Quickbase
    3,009 Ratings
    Visit Website
  • SBS Quality Management Software
    7 Ratings
    Visit Website

About

Your business critical documents such as contracts and regulations are complex. This complexity represents a real and significant risk to not only the business, but your personal reputation. The risk of misinterpretations, the loss of corporate knowledge, instances of non-conformance or late conformance, and inefficiencies have for too long been treated as being part and parcel of your business. The result is you and/or your staff are operating at a sub-optimal level and the value of these documents is not being adequately protected. Affinitext transforms your most valuable, business critical documents (contracts, standards, policies, etc) into our AI-enabled Intelligent Document Format (IDF), allowing readers of the documents to find, understand and manage the content of these documents in ways that are not possible using static, 25 year-old technologies such as Word and PDF. Affinitext makes it easy to get around your documents and/or project portfolios.

About

A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Organizations that require a contract management solution to optimize performance through intelligent documents

Audience

Medical Device Manufacturers that need an advanced Calibration Management solution

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Affinitext
Founded: 2003
United Kingdom
www.affinitext.com

Company Information

Grand Avenue Software
Founded: 2002
United States
www.grandavenue.com

Alternatives

Alternatives

SBS Quality Management Software

SBS Quality Management Software

Sunday Business Systems
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Sierra QMS

Sierra QMS

Sierra Labs

Categories

Categories

CAPA Features

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Calibration Management Features

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

Change Management Features

Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management

Complaint Management Features

Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management

Document Version Control Features

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

Preventive Maintenance Features

Condition Monitoring
Inspection Management
Maintenance Scheduling
Mobile Access
Predictive Maintenance
Purchasing
Reminders
To-Do List
Vendor Management
Work Order Management

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Vendor Management Features

Audit Management
Contact Management
Customer Database
Self Service Portal
Supplier Master Data
Transaction History
Vendor Maintained Profiles
Vendor Managed Inventory
Vendor Performance Rating
Vendor Qualification Tracking

Integrations

Microsoft 365
Microsoft Word

Integrations

Microsoft 365
Microsoft Word
Claim Affinitext and update features and information
Claim Affinitext and update features and information
Claim Grand Avenue Software and update features and information
Claim Grand Avenue Software and update features and information