Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Docuply Dot Compliance QMS

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Docuply:

About

Docuply is a cloud-based electronic quality management system (eQMS) with integrated electronic document management and an electronic trial master file (eTMF) for clinical biotechnology companies, contract research organizations and other teams working in regulated drug development. It supports controlled document creation, review, approval, version tracking and electronic signatures, plus SOP training, deviation and corrective and preventive action (CAPA) workflows, supplier management, and trial-file organization using a CDISC TMF reference model. The platform provides audit trails, training records, document search and AI-assisted features for selected quality and document workflows. Teams can organize trial records and collaborate with external sites, sponsors and suppliers. Docuply is delivered as a web service hosted in the EU for GxP-related quality and clinical documentation processes.
Dot Compliance QMS:

About

Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-Shop
Docuply:

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
Dot Compliance QMS:

Platforms Supported

Windows Supported
Mac Supported
Linux Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported
Docuply:

Audience

Clinical-stage biotech companies, small and medium-sized CROs, academic sponsors, and GxP service providers such as labs and biostatistics teams.
Dot Compliance QMS:

Audience

Designed for Pharmaceutical, Biotechnological, Medical Device & Cannabis manufacturers
Docuply:

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported
Dot Compliance QMS:

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported
Docuply:

API

Offers API Not Supported
Dot Compliance QMS:

API

Offers API Supported
Docuply:

Screenshots and Videos

Dot Compliance QMS:

Screenshots and Videos

Docuply:

Pricing

€99/user/month
The free eDMS tier supports up to 8 users. The full eQMS plan is €99 per user/month for up to 50 users; larger-team pricing is also offered. A 14-day free trial is available. Optional SSO is priced separately.
Free Version Supported
Free Trial Supported
Dot Compliance QMS:

Pricing

$10,000 / Annually
Starting at just 10,000$ a year
(validation included)
Free Version Not Supported
Free Trial Supported
Docuply:

Reviews/Ratings

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

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Dot Compliance QMS:

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
Docuply:

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported
Dot Compliance QMS:

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported
Docuply:

Company Information

Docuply
Founded: 2022
Germany
docuply.io
Dot Compliance QMS:

Company Information

QMS for Life Sciences
Founded: 2007
United States
www.dotcompliance.com
Docuply:

Alternatives

No Alternatives
Dot Compliance QMS:

Alternatives

AlisQI

AlisQI

4.5 out of 5 stars
Dot Compliance QMS:
SimplerQMS

SimplerQMS

3.0 out of 5 stars
Dot Compliance QMS:
Matrix Req

Matrix Req

Matrix One
Dot Compliance QMS:
CAQ.Net

CAQ.Net

CAQ AG Factory Systems
Docuply:
Dot Compliance QMS:
MasterControl

MasterControl

4.5 out of 5 stars
Docuply:

Categories

Quality Management Supported
Dot Compliance QMS:

Categories

Dot Compliance QMS:

Quality Management Features

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

Audit Features

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Exceptions Management Supported
Forms Management Supported
Issue Management Supported
Mobile Access Supported
Multi-Year Planning Supported
Risk Assessment Supported
Workflow Management Supported

CAPA Features

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

Change Management Features

Approval Workflow Supported
Audit Trail Supported
Automated Notifications Not Supported
Change Calendar Supported
Change Planning Not Supported
Compliance Management Supported
Prioritization Supported
Release Management Supported
Task Management Supported
Tracking & Reporting Not Supported
Training Management Supported

Complaint Management Features

Case Management Supported
Complaint Classification Supported
Corrective Actions (CAPA) Supported
Customer Complaint Tracking Supported
Feedback Management Supported
Forms Management Supported
Issue Tracking Supported
Quality Assurance Management Supported
Routing Supported
Self Service Portal Not Supported
Social Media Monitoring Not Supported
Survey Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Supported
Environmental Compliance Not Supported
FDA Compliance Supported
HIPAA Compliance Not Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Supported
Version Control Supported
Workflow / Process Automation Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Supported
Periodic Review Supported
Version Control Supported

Document Management Features

Access Controls Supported
Archiving & Retention Supported
Collaboration Tools Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Supported
Document Capture Supported
Document Conversion Supported
Document Delivery Supported
Document Indexing Supported
Document Retention Supported
Electronic Signature Supported
Email Management Not Supported
File Recovery Supported
File Type Conversion Supported
Forms Management Supported
Full Text Search Not Supported
Offline Access Supported
Optical Character Recognition Not Supported
Print Management Supported
Version Control Supported

Risk Management Features

Alerts/Notifications Supported
Auditing Supported
Business Process Control Supported
Compliance Management Supported
Corrective Actions (CAPA) Supported
Dashboard Supported
Exceptions Management Supported
Internal Controls Management Supported
IT Risk Management Supported
Legal Risk Management Supported
Mobile Access Supported
Operational Risk Management Supported
Predictive Analytics Supported
Reputation Risk Management Supported
Response Management Supported
Risk Assessment Supported
Docuply:

Integrations

Google Workspace Supported
Microsoft Entra ID Supported
Okta Supported
Salesforce Not Supported
Dot Compliance QMS:

Integrations

Google Workspace Not Supported
Microsoft Entra ID Not Supported
Okta Not Supported
Salesforce Supported
Docuply:
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Dot Compliance QMS:
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