• There are no suggestions because the search field is empty.
Operational Software Compliance - Software Solutions & Services - QbD Group

Operational Software Compliance

Maintaining compliance with regulatory standards is no small task. It’s a constant challenge to keep software systems secure, reliable, and up-to-date while effectively managing the complexities of industry regulations.

At QbD Group, we’re here to ease those concerns. Our operational software compliance services are designed to ensure your software systems meet industry standards and regulations, enhancing data security and system reliability. 

 

What is operational software compliance?

MAINTAINING COMPLIANCE WITH REGULATORY STANDARDS IN THE OPERATIONAL PHASE

 

Operational Software Compliance ensures ongoing adherence to regulatory standards, industry best practices, and internal policies during the operational phase of software systems. 

QbD Group offers robust solutions that ensure your systems not only meet compliance requirements but also operate efficiently and securely over their lifecycle. 

Our services include periodic reviews, impact assessments for software updates, and recurrent validations. 

QbD Group’s comprehensive approach helps maintain the validated state of your systems, ensuring they continue to function effectively within their intended environments. 

 

Why is operational software compliance important?

  • Mitigates risks of non-compliance: avoid legal penalties, fines, and reputational damage by ensuring adherence to regulations.

  • Protects data security and integrity: safeguard sensitive data from breaches and unauthorized access.

  • Maintains system reliability: reduce downtime, errors, and disruptions for uninterrupted operations.

  • Simplifies regulatory complexity: provides a structured framework for managing compliance requirements.

  • Builds stakeholder trust: demonstrates a commitment to best practices, fostering trust with customers, partners, and regulators. 
Operational Software Compliance - Software Solutions and Services - QbD Group

 

Benefits of operational software compliance

Ensure your systems meet regulatory standards while enhancing security, integrity, and trust. Compliance not only protects data but also strengthens operational performance and reduces risks.

Regulatory adherence

Regulatory adherence

Ensures compliance with relevant laws and standards. 

Enhanced data security

Enhanced data security

Protects sensitive data from breaches and unauthorized access. 

Improved operational integrity

Improved operational integrity

Maintains system reliability and functionality.

Reduced risks

Reduced risks

Identifies and addresses compliance gaps to mitigate potential issues. 

Increased stakeholder trust

Increased stakeholder trust

Demonstrates a commitment to compliance and best practices. 

Operational Software Compliance - Software Solutions and Services - QbD Group

Our way of working

At QbD Group, we offer a comprehensive approach to operational software compliance, from assessment to implementation:

  • Initial Assessment: We begin by identifying and scoping the recurring validation activities required for your software. This ensures a clear understanding of your needs and sets a strong foundation for success.
  • Pilot Implementation: To refine our approach, we initiate a pilot project under a time & material model. This helps validate time and resource estimates, fine-tune the process, and confirm the volume of compliance activities required.
  • Comprehensive Planning: Using insights from the pilot, we develop a detailed project plan for ongoing compliance activities. This plan incorporates in-house compliance tools to support task tracking and execution, ensuring continuous monitoring and timely adjustments to align with your business needs.
  • Monitoring and Support: Our support doesn’t stop with the plan. We provide ongoing monitoring and adjustments to ensure your systems remain compliant and validated, protecting your operations from disruptions and risks.

Why partner with QbD Group?

By partnering with QbD Group, you gain: 

  • Expertise in compliance: leverage QbD Group’s deep knowledge of compliance requirements and validation processes.
  • Reduced workload: outsource compliance activities to free up internal resources.
  • Cost-effective solutions: consider near-shore or offshore options for potentially lower costs.
  • Proven tools and methods: benefit from QbD Group’s established tools and methodologies. 
Why-self-inspections-or-internal-audits-are-essential-for-your-QMS-1536x864

Related content

preview_image
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.
preview_image
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.
preview_image
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!
preview_image
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.
preview_image
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.
preview_image
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.
preview_image
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.
preview_image
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.
preview_image
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!
preview_image
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.
preview_image
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.
preview_image
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.
preview_image
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.
preview_image
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.
preview_image
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.
contact-mail

Get in touch

Ready to streamline your operational software compliance?

QbD Group provides expert guidance and tailored solutions to ensure your software systems stay compliant, secure, and efficient throughout their lifecycle.  

Let’s achieve seamless compliance together!

Circles_get in touch_Software solutions & services-1