QMex logo

QMex

by BTS · Since 2012
No reviews yet
ActiveAvailable globallyCloudOn-premise
Quick facts
VendorBTS
Year launched2012
StatusActive
LocationMerkez - HQ Barbaros Mahallesi, Begonya Sk. No:1 , Nidakule Batı, İç Kapı No:2 Batı Ataşehir, İstanbul, TR
Countries servedGlobal
Languages39
Integrations
Free tier
Free trial
Contact salesYES

About QMex

QMex is a compliance management software from BTS that supports regulatory adherence in various industries. It provides tools for document management, risk assessment, and audit tracking so organizations can maintain compliance effectively. With QMex, users can manage their compliance documentation, assess potential risks, and track audit findings in one platform. This simplifies the management of compliance processes and helps organizations meet regulatory requirements efficiently. Key capabilities: document management risk assessment audit tracking reporting tools user management Best for: compliance officers and regulatory professionals that need to manage compliance and risk in their organizations.

**QMex by BTS** is a powerful Quality Management Software (QMS) solution that caters to organizations in highly regulated industries, providing essential tools to streamline and enhance GxP (Good Practice) processes. It stands out as a modular and versatile platform, purpose-built to facilitate compliance with stringent regulatory standards like 21 CFR Part 11 and GAMP 5, making it particularly valuable for industries such as pharmaceuticals, manufacturing, and healthcare. The software is accessible via web browsers, which adds to its flexibility and ease of use. Organizations looking to strengthen their quality management processes and regulatory adherence find QMex an effective tool for achieving these goals, with a range of comprehensive features that support a structured, efficient, and compliant workflow. The user interface of QMex is intuitively designed, ensuring a seamless user experience. The layout is clean and well-organized, with key modules and features readily accessible from the dashboard. This design minimizes the learning curve, making it easier for users, especially those new to quality management software, to quickly adapt.

Pros & Cons

What users like
  • +Easy to use and user-friendly (all reviewers agreed)
  • +Fast and responsive customer support (according to some reviewers)
  • +Good data traceability and process follow-up (mentioned by multiple reviewers)
  • +Eliminates paper archives and document searching (mentioned by one reviewer)
  • +Compliant with 21 CFR Part 11 (mentioned on the product page)
  • +Secure and customizable with technical assistance (mentioned by one reviewer)
  • +Integrates with other corporate applications (mentioned on the product page)
  • +Accessible via internet browsers (mentioned on the product page)
  • +Validated according to GAMP 5 (mentioned on the product page)
  • +Manages all Quality activities (mentioned by one reviewer)
  • +Easy document access and management (mentioned by one reviewer)
What users flag
  • Limited cloud functionality (mentioned by one reviewer,がありますが(shikashi gantena - but) the vendor offers a cloud solution)
  • Dashboards could be more user-friendly (mentioned by one reviewer, the vendor acknowledges this and is working on improvements)
  • Audit trail list could be more intelligible (mentioned by one reviewer)
  • Potential for slowness (mentioned by one reviewer)
  • Dependence on technical support for customization (mentioned by one reviewer)
  • Lacks modular workflow design by users (mentioned by one reviewer)

Features

Key features

1. Modular
Designed to fit your specific business processes.
2. Scalable
Grows with your business needs.
3. Secure
Complies with 21 CFR Part 11 and validated according to GAMP 5 for data security.
4. Cloud-based
Accessible from anywhere with an internet browser.

Additional features

1. Data Security
Customer-specific data isolation on MS Azure SaaS platform.
Secure storage with Database Storage Services, Active Directory, and App Services.
2. Customization
Modules can be implemented to match your specific business processes.
3. Scalability
Cost-effectively scales as your data size and number of users increase.
4. Computerized System Validation
Validated according to FDA and GAMP 5 requirements.
5. Cost Advantage
Saves time, human resources, paper, printing materials, and physical storage space.
6. Data Integrity
Secure data storage and monitoring compliant with ALCOA+ requirements.
7. Easy Reporting
Generates reports in PDF, Excel, and with Dashboard features.
8. Time Saving
Improves task follow-up, simplifies audits, and expedites document preparation, approval, and distribution.
9. 21 CFR Part 11 Compliance
Meets all requirements for 21 CFR Part 11.
10. Ready-to-use Validation Document Set
Includes sample documents compliant with FDA and GAMP 5.

Pricing

Free trial
Free version
Request a quote
Promo Offer

Countries & Languages

Global
Countries served
39
Interface languages
12
Billing currencies

Interface languages

EnglishSpanishFrenchGermanPortugueseItalianChineseJapaneseKoreanRussianDutchArabicSwedishDanishNorwegianFinnishPolishTurkishCzechSlovakHungarianRomanianGreekBulgarianCroatianSerbianSlovenianLithuanianLatvianEstonianUkrainianBelarusianGeorgianArmenianAzerbaijaniKazakhUzbekTajikTurkmen.

Billing currencies

🇺🇸USD🇪🇺EUR🇬🇧GBP🇯🇵JPY🇦🇺AUD🇨🇦CAD🇨🇭CHF🇨🇳CNY🇸🇪SEK🇮🇳INR🇷🇺RUB🇳🇿NZD

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