Qualcy QMS

Qualcy QMS

Qualcy Systems
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About

Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.

About

Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences. It drafts IQ/OQ/PQ protocols, GAMP 5 classifications and audit trails straight from source documents (URS, P&IDs, SOP libraries), with every requirement traced end-to-end through a queryable graph that replaces spreadsheet RTMs. All ALCOA+ data-integrity criteria are monitored on every record, not samples, with humans reviewing and approving agent output. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others). Built for Heads of Validation and validation consultancies at pharma, biotech and medical-device companies. Annual per-site licence, quoted on request; an 8-12 week fixed-fee pilot (one system) is available.

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Bio-Medical companies (including Biotech, Pharma and Medical Device)

Audience

Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

No images available

Pricing

$799 per month
Free Version Supported
Free Trial Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 4.0 / 5
support 5.0 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Pros & Cons from Real Users

Pros

  • Simple and easy to manage the document change controls. Integrated training module automates the training records. The QMS package comes with calibration and asset management module, which is a big plus.

Cons

  • It took us little longer than expected to get started. It has been a good experience so far.

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Company Information

Qualcy Systems
Founded: 2014
United States
www.qualcy.com

Company Information

Qualitum
qualitum.ai

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Res_Q

Res_Q

Sware

Categories

Categories

Calibration Management Features

Calibration Instructions Supported
Calibration Schedules Supported
Compliance Management Supported
Device History Not Supported
Due Date Tracking Supported
Gage Management Supported
Label Printing Supported
Measurement Readings Not Supported
Multi-Station Management Not Supported
Out-of-Tolerance Notification Not Supported
Statistical Data Reporting Not Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Integrations

AWS Backup Supported
AWS Cloud9 Supported
Gmail Supported
Microsoft 365 Supported
Microsoft Azure Supported
Microsoft Outlook Supported
SAP Analytics Cloud Supported

Integrations

AWS Backup Not Supported
AWS Cloud9 Not Supported
Gmail Not Supported
Microsoft 365 Not Supported
Microsoft Azure Not Supported
Microsoft Outlook Not Supported
SAP Analytics Cloud Not Supported
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