Related Products
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About
PaKalite is a quality management system for small and mid-sized automotive and industrial manufacturers, built on IATF 16949, ISO 9001/14001/45001, AIAG (PPAP, APQP, MSA, SPC) and VDA 6.3.
17 integrated modules: PPAP (18 elements, PSW, MSA/GRR), APQP (5 phases), audits (14 types, question bank, scoring, findings to CAPA), KPI scorecards (targets, deviation alerts, supplier rating), inspection & control plans (12 types, SPC Cp/Cpk, quarantine, EN 10204 certs), calibration, drawing revision control, nonconformity (NCR/8D), continuous improvement (Kaizen, 5S), supplier quality, management review, meetings, HR competence and training, TPM maintenance, OHS, and document management.
Modules feed each other: an audit finding opens a corrective action; a chronic KPI deviation triggers one automatically. Cloud data with a Windows desktop client and an Android shop-floor app. PDF reporting, Excel import, role-based permissions, per-company data isolation. Free plan. Turkish interface.
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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
Automotive ,Mechanical or Industrial Engineering,Machinery,Plastics,Mining & Metals,Manufacturing / Industrial Automation
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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 VideosNo images available
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Screenshots and Videos |
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Pricing
$0
Free Version
Free Trial
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Pricing
$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
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 InformationPaKalite
Founded: 2022
Turkey
pakalite.com
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Company InformationSimplerQMS
Founded: 2017
Denmark
www.simplerqms.com
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Categories |
Categories |
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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
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
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Integrations
Microsoft 365
Microsoft Entra ID
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