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Description

PaKalite serves as a comprehensive quality management system tailored for small to mid-sized manufacturers in the automotive and industrial sectors, adhering to standards such as IATF 16949, ISO 9001/14001/45001, AIAG (including PPAP, APQP, MSA, SPC), and VDA 6.3. The system comprises 17 interconnected modules, which include elements for PPAP (18 elements, PSW, MSA/GRR), phases for APQP (5 phases), various audit types (14 types, question bank, scoring, findings leading to CAPA), KPI scorecards (featuring targets, deviation alerts, and supplier ratings), as well as inspection and control plans (12 types, utilizing SPC Cp/Cpk, quarantine, and EN 10204 certifications). Additional modules facilitate calibration, drawing revision control, nonconformity management (NCR/8D), continuous improvement practices (like Kaizen and 5S), supplier quality assurance, management reviews, meeting tracking, HR competence and training, TPM maintenance, occupational health and safety, and document management. These modules work in synergy: for instance, an audit finding can initiate a corrective action, and persistent KPI deviations can automatically trigger responses. The platform operates in the cloud and is complemented by a Windows desktop client and an Android application designed for shop-floor use. Moreover, it supports PDF reporting, Excel data importation, role-based access permissions, and ensures data isolation per company, all while offering a free plan and featuring a Turkish interface for user accessibility. This comprehensive approach enhances operational efficiency and quality assurance across diverse manufacturing processes.

Description

QFacts is a comprehensive cloud-based Quality Management System designed specifically for pharmacies, compounding facilities, and other regulated sectors. It encompasses the entire quality lifecycle, featuring controlled document management with versioning and approval workflows, training and competency tracking with curriculum-aligned assignments, as well as event and complaint management, root cause analysis, CAPA oversight, and change control, all accompanied by thorough audit trails. This system is built to comply with GAMP 5 and adhere to European GMP and GDP standards, employing role-based access controls that span organizations, locations, and departments. Quality managers can customize review workflows, keep track of due dates, and oversee compliance via real-time dashboards. Each action taken within the system is meticulously logged and traceable, providing inspectors and auditors with a transparent chain of accountability that extends from document approval through to the completion of training and the resolution of corrective actions. By ensuring such detailed oversight, QFacts significantly enhances the overall efficiency and reliability of quality management processes.

API Access

Has API

API Access

Has API

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Screenshots View All

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Integrations

No details available.

Integrations

No details available.

Pricing Details

$0
Free Trial
Free Version

Pricing Details

$17/month/user
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

PaKalite

Founded

2022

Country

Turkey

Website

pakalite.com

Vendor Details

Company Name

QFacts

Founded

2024

Country

Belgium

Website

qfacts.be

Product 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

Product 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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