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
No
API Access
Has API
No
Integrations
Jira
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
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
Yes
Free Version
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
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
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)
No
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
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
No
Barcode Generation
No
Claims Management
Yes
Compounding
No
E-Prescribing
No
Electronic Signature
Yes
Forms Management
Yes
Insurance Processing
No
Inventory Management
No
Multi-Store Management
No
Online Refills
No
Pill Database
Yes
Pill Imaging
No
Point of Sale (POS)
No
Prescription Processing
No
Rx Image Scanning
No
Signature Capture
No
Product Features
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
No
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
Yes
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes