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Description
SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.
SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5.
The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.
SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.
Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.
Description
anicomply is a dynamic Electronic Batch Record (EBR) system tailored for pharmaceutical manufacturers, contract development and manufacturing organizations (CDMOs/CMOs), active pharmaceutical ingredient (API) producers, and various other industries where quality is paramount.
This platform digitizes traditional paper-based or hybrid batch processes into efficient, executable workflows, distinguishing itself with remarkable speed; a standard recipe can be converted from a standard operating procedure (SOP) into an active digital workflow in just a matter of hours, rather than taking weeks.
By employing a declarative methodology, process owners can implement numerous workflow modifications with minimal reliance on developers, which significantly decreases the need for programming, reduces iteration cycles, and alleviates resource constraints.
The system is designed with essential features such as an integrated audit trail, electronic signatures, version control, and a four-eyes review process to meet GxP compliance requirements inherently.
As a web-based application, it operates seamlessly across various devices and offers both cloud and on-premises deployment options, while also integrating smoothly with ERP, MES, and SCADA systems.
Additionally, anicomply generates structured process data that enhances review-by-exception, ensures traceability, facilitates analytics, and lays the groundwork for future artificial intelligence applications.
This comprehensive functionality not only improves operational efficiency but also bolsters regulatory compliance in manufacturing processes.
API Access
Has API
API Access
Has API
Screenshots View All
No images available
Integrations
Microsoft 365
Microsoft Entra ID
Pricing Details
$13,750/year
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Vendor Details
Company Name
anic GmbH
Founded
1996
Country
Germany
Website
www.anic-gmbh.de
Product Features
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Quality Management
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