Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Pharmaceutical and biotech firms face significant challenges in adhering to control documentation standards in their daily operations. Efficient management and regulation of documents are essential components of any quality assurance and compliance framework. Regulatory bodies around the globe expect all companies in regulated industries to adhere to the latest best practices throughout their manufacturing processes. To address these challenges, Pharma Soft Sol has created a Document Management System (DMS) that facilitates the control and distribution of Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs), and other essential documents. Such document management solutions not only lower compliance costs but also enhance both process efficiency and product quality. The softDMS is designed to provide timely access to the necessary information, reducing the likelihood of errors and miscommunication, which in turn diminishes risks, labor hours, and documentation inaccuracies. By implementing this system, organizations can create a more streamlined operation that aligns with regulatory expectations while fostering continuous improvement in their workflows.
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.
API Access
Has API
API Access
Has API
Integrations
Microsoft 365
Microsoft Entra ID
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$13,750/year
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
Pharma Soft Sol
Country
India
Website
softdms.com
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Product Features
Pharmacy
Automatic Refills
Barcode Generation
Claims Management
Compounding
E-Prescribing
Electronic Signature
Forms Management
Insurance Processing
Inventory Management
Multi-Store Management
Online Refills
Pill Database
Pill Imaging
Point of Sale (POS)
Prescription Processing
Rx Image Scanning
Signature Capture
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