Average Ratings 0 Ratings
Average Ratings 10 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
qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform.
Best For:
- Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS.
- Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.
API Access
Has API
API Access
Has API
Integrations
Jira
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
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
qmsWrapper
Country
Canada
Website
www.qmswrapper.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
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
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