CaliberBRMCaliber Technologies
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Related Products
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About
In pharmaceutical manufacturing, recording shop floor activities in real-time are essential to ensure quality and compliance with 21 CFR Part 11 and GMPs. An automated system ensures that batch records are error-free and retrievable and the batch manufacturing processes are trackable. EBR software like CaliberBRM eliminates paper-based processes and risks associated with them to ensure data integrity and product quality. In life sciences and highly regulated industries, real-time entry recording of 4Ms is inevitable. It enhances the business process. You can save a lot of time and effort by digitalizing batch production records. Electronic Batch Record (EBR) System gives you complete control of the 4Ms. CaliberBRM reduces inventory wastage, checks and aligns manpower as per need, deals with instrument management, reduces review cycle time, etc. It in turn reduces operating costs. Quality Review Management (QRM) stresses performing review by exception to accelerate batch release.
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About
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry.
This comprehensive QMS platform 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, ICH Q10, and others.
The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience.
SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Pharmaceutical manufacturing companies looking for a solution to manage and ensure quality and compliance
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Audience
Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
$13,750/year
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationCaliber Technologies
Founded: 2001
India
caliberuniversal.com/solutions/batch-record-management/
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Company InformationSimplerQMS
Founded: 2017
Denmark
www.simplerqms.com
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Categories |
Categories |
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Manufacturing Features
Accounting Integration
ERP
Maintenance Management
MES
MRP
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management
Manufacturing Execution Features
Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability
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Audit Features
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
CAPA Features
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Compliance Features
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Control Features
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Quality Management Features
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
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