21-CFR-Part-11-compliance-checklist-does-your-system-comply-QbD-1536x864

Software Solutions for Pharma & MedTech

Where compliance, efficiency, and innovation drive success

Don’t be late to the digital transformation of the life sciences industry. QbD Group leverages deep expertise in business processes, regulatory requirements, and IT.

We provide tailored software solutions and comprehensive services to help you strike the right balance between compliance and business efficiency. Stay ahead of the online revolution and bring your products to market swiftly and successfully.

Discover our services and solutions

Expertise

Your digital challenges are in safe hands with our expertise that bridges business processes, regulatory gaps, and IT.

Technology agnostic approach

Our approach ensures that your unique needs dictate the solutions we provide, not the limitations of a specific technology.

Full life sciences coverage

Our solutions and services cover all life sciences areas from medical devices (MD) and in vitro diagnostics (IVD) to ATMPs and medicinal products.

Full lifecycle support

We help you navigate the complexities of digital transformation with confidence and agility, ensuring your whole journey is as swift and successful as possible.

Market trends & challenges

In the rapidly evolving digital landscape, life sciences organizations face mounting regulatory requirements and increasing pressure to optimize efficiency. Software validation, data integrity, and system digitization are now critical to ensuring compliance while driving operational improvements.

At the same time, businesses must adapt to new technologies and address cybersecurity risks without compromising system reliability. The shift toward cloud-based platforms and automation creates both opportunities and challenges, requiring expertise and a future-focused strategy.

QbD Group helps you navigate these complexities with tailored software solutions that prioritize compliance, streamline processes, and prepare your organization for tomorrow’s demands.

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Our software services in

All

Operational Software Compliance

Need seamless operational software compliance? QbD ensures your systems meet industry regulations, enhancing data security and reliability.

Digitalization

Our expertise in software implementation and IT partnerships ensures a seamless transition from traditional methods to advanced digital solutions, allowing you to...

Medical Device Software Compliance

Our service offers a tailor-made framework for medical device software compliance, ensuring adherence to MDR, IVDR, ISO13485, ISO14791, and other key standards. We...

AI/ML Compliance

Looking for guidance while developing software including AI-models? QbD offers AI/ML compliance support helping you be compliant with the latest standards and...

Data Governance

QbD Group offers data governance support, helping you comply with the latest regulations and shorten your path to market.

Software Validation, Central IT Systems

Ensure your software solutions meet regulatory standards with our comprehensive Software Validation services. We specialize in Computer System Validation (CSV) to...

Data Integrity

Ensure your data's accuracy and consistency with our tailored data integrity services. We provide expert guidance on complying with the latest regulatory standards,...

Software Implementations

Transform your life science organization with our expert software implementation services. Our team ensures seamless integration and compliance, delivering customized...

IT Infrastructure Qualification

Ensure your IT systems meet regulatory standards with our IT infrastructure qualification services. We specialize in validating on-premises and cloud-based systems to...

Paperless Validation

Transform your validation process with our Paperless Validation service, offering a digital, efficient, and error-free solution for regulated industries. Say goodbye to...

Our software solutions

IFUcare

Discover how our eIFU service can help IVD and medical device manufacturers leave paper IFUs behind, saving costs, simplifying processes, and ensuring regulatory compliance. Developed by regulatory experts, we focus on compliance and risk management.

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Scilife™

From document control and training to CAPAs and AI-driven KPIs, Scilife ensures full traceability, integration, and compliance. Its intuitive interface makes it easy to get started, and its powerful features make staying on top of quality a breeze.

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Why QbD Group?

QbD Group provides trusted software solutions to life sciences organizations worldwide. With over a decade of experience, our team delivers compliance, efficiency, and innovation through tailored strategies that meet your unique needs.

What sets us apart?

Proven expertise: Over 10 years of experience in life sciences software solutions.
Tailored support: Customized strategies to meet your organization’s goals.
Global presence: Compliance expertise across international markets.
Full lifecycle services: From implementation to ongoing maintenance, we’ve got you covered.

Partner with QbD Group for software solutions that drive success at every stage.

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+10 years of experience

Full lifecycle support

Global presence

Best Managed Company

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Have a question? Let's talk Software Solutions!

Our team of experts at QbD Software Services & Solutions is here to answer your questions, provide insights, or discuss how we can support your project. Whether you're looking to optimize compliance, streamline workflows, or harness the power of data in life sciences, we’re ready to help. Share your details, and we’ll be in touch shortly!

Latest insights

Whitepaper

A Complete Guide to Computer System Validation

This guide aims to bring context and define the necessary and appropriate strategies for the validation of computerized systems. Download now.

Whitepaper

Digital Health - Exploring the landscape and future opportunities

This whitepaper informs you about digital health, key technology pillars, and new opportunities to anticipate future trends in your healthcare sector.

Whitepaper

How to keep computerized systems in the operational phase

Ensure compliance and efficiency with best practices for maintaining computerized systems in the operational phase. Download our expert whitepaper now!

Webinar

From Requirements to Code: a unified MDSW development cycle that covers all requirements

Watch our webinar on demand to master medical device software development. Learn about IEC standards, cybersecurity, AI integration, and FDA expectations.

Whitepaper

Mobile health on the rise: exploring the regulatory landscape for reimbursement

This whitepaper will help you navigate the maze of the DTx regulatory environment, highlighting several important countries and regulations.

Whitepaper

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

Learn how to comply with GMP, GCP, and GLP regulations using the GAMP 5 Software Validation Approach. Download the whitepaper for more insights.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Whitepaper

Standards and regulations for software used in Medical Devices

Explore the essential standards and regulations for software used in Medical Devices, including IEC 62304 and IEC 82304. Download now.

Whitepaper

Annual Product Quality Review in Pharma

Want to learn more about the importance, benefits, and key challenges related to the Annual Product Quality Review in Pharma? Then read on quickly!

Whitepaper

21 CFR Part 11 compliance checklist

Want to assess whether a computer system generates electronic records and uses electronic signatures, and whether the system complies with Part 11 of 21 CFR? Download this free checklist.

Webinar

Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

This webinar on demand will tell you more about the second edition of GAMP 5.

Webinar

Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices

Explore the impact of Artificial Intelligence and Machine Learning on medical device validation and verification processes.

Whitepaper

GAMP categories for computerized systems: what are they and what are they for?

In this whitepaper, you will learn what GAMP is, what GAMP categories are for, and where to start if you are facing computerized systems validation.

Whitepaper

EUDRALEX Volume 4 Annex 11 Compliance Checklist

Assess your computer system's compliance with EudraLex Volume 4 Annex 11 guidelines using our checklist. Download now for GMP assurance.

Whitepaper

From V-model to Agile: how to embrace automation as part of the computerized system validation approach

This white paper explores why IT is shifting to agile, focuses on the prevalent Scrum methodology, and concludes with guidance on adapting system validation processes.

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