Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

To facilitate efficient operations and timely progress in your projects, it is crucial to implement a well-defined document control procedure that enhances the flow of information. Integrating this document control process within a project document management system ensures that every team member follows the established guidelines, from document creation to approval and distribution, ultimately leading to improved quality and consistency in deliverables for clients. Typically, a document control procedure for engineering drawings, which encompass technical documentation, should also include key details such as the document owner's information, a numbering system, revision history, and the identities of reviewers and approvers. Utilizing a document control tool enables you to verify that all these essential elements are addressed prior to publication, ensuring that the information remains accurate and easily accessible. This approach not only streamlines operations but also fosters accountability among team members throughout the project lifecycle.

Description

Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

$899 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 Yes 
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) No 
Online Support Yes 

Customer Support

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

Types of Training

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

Types of Training

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

Vendor Details

Company Name

AGTIV Consulting

Founded

2008

Country

Malaysia

Website

www.agtiv.com

Vendor Details

Company Name

Sierra Labs

Country

United States

Website

www.sierralabs.com/quality-management/

Product Features

Document Control

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

Document Management

Access Controls No 
Archiving & Retention No 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing Yes 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion Yes 
Forms Management No 
Full Text Search No 
Offline Access Yes 
Optical Character Recognition Yes 
Print Management No 
Version Control Yes 

Product Features

CAPA

Audit Management Yes 
CAPA Planning No 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing No 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance Yes 
Risk Management No 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback Yes 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management No 
Periodic Review Yes 
Version Control Yes 

Document Version Control

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

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control No 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Risk Management

Alerts/Notifications Yes 
Auditing No 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard No 
Exceptions Management Yes 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management No 
Mobile Access Yes 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management No 
Response Management Yes 
Risk Assessment Yes 

Alternatives

Qualis DMS Reviews

Qualis DMS

Agaram

Alternatives

Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
DocControl Reviews

DocControl

QMS ECommerce Solutions
QT9 QMS Reviews

QT9 QMS

QT9 Software
Sierra QMS Reviews

Sierra QMS

Sierra Labs