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What is SimplerQMS?

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, 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, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

What is PaKalite?

PaKalite is an all-encompassing quality management solution designed specifically for small to medium-sized manufacturers operating in the automotive and industrial fields, ensuring compliance with various standards including IATF 16949, ISO 9001/14001/45001, AIAG (which encompasses PPAP, APQP, MSA, SPC), and VDA 6.3. The system consists of 17 interconnected modules that cover aspects such as PPAP (with 18 elements, PSW, MSA/GRR), stages of APQP (5 stages), multiple audit types (14 types, complete question bank, scoring, and findings leading to CAPA), KPI scorecards (including targets, alerts for deviations, and assessments of suppliers), as well as inspection and control frameworks (12 types, employing SPC Cp/Cpk, quarantine processes, and EN 10204 certifications). Additional features include modules for calibration, managing drawing revisions, handling nonconformities (NCR/8D), promoting continuous improvement methodologies (like Kaizen and 5S), assuring supplier quality, conducting management reviews, tracking meetings, overseeing HR competencies and training, implementing TPM maintenance, ensuring occupational health and safety, and managing documentation. These modules are designed to operate cohesively; for example, an audit finding can lead to the initiation of a corrective action plan, and ongoing KPI discrepancies can automatically trigger necessary responses. The platform is cloud-based and is further enhanced by a Windows desktop client and an Android application intended for shop-floor functionality. Furthermore, it offers capabilities such as PDF reporting, Excel data import, role-specific access controls, and maintains data segregation for each company, while also providing a free plan and featuring a user-friendly Turkish interface. This holistic approach significantly boosts operational efficiency and quality management across a variety of manufacturing practices, making it a vital tool for organizations aiming for excellence.

Media

Media

No images available

Integrations Supported

Microsoft 365
Microsoft Entra ID

Integrations Supported

Microsoft 365
Microsoft Entra ID

API Availability

Has API

API Availability

Has API

Pricing Information

$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Version
Free Trial Offered?

Pricing Information

$0
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Company Facts

Organization Name

PaKalite

Date Founded

2022

Company Location

Turkey

Company Website

pakalite.com

Categories and 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

Categories and Features

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

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