New Version of the ISPE GAMP Guide: Innovating Data Integrity in GCP Systems

The International Society for Pharmaceutical Engineering (ISPE) has recently launched the second edition of its GAMP Good Practice Guide for GCP Computerized Systems and Data Integrity. This guide provides an essential framework for the use of computerized systems in clinical research, helping to ensure data quality and regulatory compliance.

We are pleased to announce that Anna Dachs Soler, Life Science Consultant at Ambit Iberia, was one of the key collaborators in preparing this important guide, reinforcing our company’s commitment to excellence and quality in the pharmaceutical industry.

What is the ISPE GAMP Guide for GCP Systems and why is it important?

The ISPE GAMP (Good Automated Manufacturing Practice) Good Practice Guide has become a crucial reference for professionals working with computerized systems in regulated environments. In this new edition, the guide focuses especially on systems used in the context of GCP (Good Clinical Practice), with emphasis on data integrity.

Data integrity in the clinical field is fundamental to guarantee the quality of research results and patient safety. As technology advances and research environments digitalize, the need for clear and applicable guidelines becomes more evident. This second edition incorporates significant improvements to adapt to current regulatory requirements and the growing use of digital solutions in the industry.

It fills us with pride to know that our expert Anna Dachs Soler had an active role in the creation of this guide. Her experience in computerized system validation and regulatory compliance was key to Ambit Iberia’s contribution to this international project.

Anna Dachs Soler comments: "Being able to collaborate on the preparation of this guide has been a very enriching experience. I am grateful to have been able to meet and work alongside international-level experts, sharing experiences and viewpoints that have turned into common knowledge. Although it required great dedication and certain challenges due to working across different time zones, it is a source of great pride to have been part of this international team of experts."

This collaboration underlines our commitment at Ambit Iberia to continuous improvement and leadership in the field of system validation and data integrity, as well as the digitalization of the Life Science sector, ensuring regulatory compliance. Participating in the elaboration of this guide not only demonstrates our technical capability, but also our desire to drive progress in the pharmaceutical industry.

In this second edition of the GAMP Guide, new appendices addressing key areas for digitalization and data integrity in clinical trials have been incorporated. Below is a summary of the most prominent appendices:

1. Appendix 1: Data Privacy in Clinical Trials:
   This appendix focuses on digitalization in the context of data privacy protection of participants during clinical trials, complying with applicable regulations. Although it is a topic closely related to data privacy regulations, it proves crucial to be well-informed for future projects.
2. Appendix 2: Decentralized Clinical Trials:
   Focuses on digitalization through the use of digital health technologies and devices for data collection in decentralized environments. It includes necessary requirements to apply these systems and digital training requirements. The pandemic accelerated interest in working in a decentralized manner, which allows reaching more places and people, generating more representative data. At Ambit Iberia, we boost collaboration with software vendors, ensuring data integrity compliance. Furthermore, through our gap analysis (gap analysis), we identify gaps in data integrity and provide specialized digital training to ensure effective and safe implementation.
3. Appendix 3: Computerized System Evaluation in Clinical Sites:
   This appendix offers a questionnaire to evaluate the suitability of computerized systems used at clinical sites. At Ambit Iberia, we can support CROs and clinical sites with the implementation of these regulations, especially regarding evaluation and maintenance of system validation, areas where many doubts usually arise.
4. Appendix 4: Good Clinical Laboratory Practice (GCLP):
   This appendix details the necessary processes and controls to ensure data and sample integrity in clinical laboratories during trials. At Ambit Iberia, we offer specialized support to ensure clinical laboratory processes meet regulatory requirements, securing data integrity and quality in sample handling.
5. Appendix 5: Use of Data Science and Artificial Intelligence in Clinical Trials:
   It describes how Data Science and Artificial Intelligence can optimize clinical trial processes and accelerate results. Includes principles and requirements to consider when implementing AI. At Ambit Iberia, together with our partners, we are prepared to ensure alignment with new technologies and maximize future collaboration opportunities in AI use within the Life Science sector.
6. Appendix 6: Real-World Data / Real-World Evidence:
   This appendix addresses digitalization through the use of real-world data sources, such as electronic health records, and how these are integrated and validated to generate clinical evidence. This is an area of great importance and growing trend, as it has the potential to deliver significant health benefits if developed correctly. At Ambit Iberia, we are committed to supporting these initiatives and providing solutions that enable effective integration of these technologies.

These new appendices represent a significant expansion in the guide's scope, covering key aspects that reflect the current reality of clinical research and the potential of emerging technologies.

Benefits of the New Guide for the Industry

The ISPE GAMP Guide for GCP Systems is an essential resource for any professional involved in clinical research and the pharmaceutical industry. Below, we highlight some of the main benefits this guide offers:

• Clarity in Regulatory Compliance: Offers a clear and applicable framework to ensure that systems used comply with current GCP regulations and maintain quality throughout the system life cycle.
• Improvement in Data Integrity: Provides tools and recommendations to ensure data is collected, stored, and managed securely, reducing risks and assuring reliability.
• Best Practices for Validation: The guide presents updated best practices for system validation, which is crucial to minimize risks and ensure quality.
• Adaptation to New Technologies: In this new edition, adaptation to modern digital environments has been incorporated, helping organizations face new challenges arising from the use of emerging technologies

How Can Ambit Iberia Help You?

Ambit BST's experience spans several key areas to ensure quality and compliance in the pharmaceutical industry. We are not only experts in data integrity and computerized system validation, but we also offer consulting, auditing, and specialized training services.

Additionally, we provide support to set up and maintain Quality Management Systems (QMS), maintain validation status through a periodic review service for computerized systems, etc., especially when organizations lack internal personnel. We support our clients in the identification and implementation of new technological solutions that allow process digitalization and improve regulatory compliance.

At Ambit Iberia, we work closely with our clients to provide customized solutions that ensure regulatory compliance and quality, from the planning phase to the continuous operation of computerized systems.

Connect with Us

The publication of this new ISPE guide marks a significant milestone in the pharmaceutical industry. At Ambit Iberia, we are proud to have contributed our grain of sand to improve the quality and compliance of GCP systems. If you want to know how we can help you implement these best practices in your organization, do not hesitate to contact us by clicking here.

We also invite you to subscribe to our newsletter to stay up to date with the latest industry news and access resources that can transform computerized system management in your company. We are here to help you achieve success every step of the way!

At AMBIT Iberia, we have been experts for over 20 years in the development of strategies and IT solutions. We help the pharmaceutical, medical device, and IVD (in vitro diagnosis) medical device sectors to comply with regulations throughout the entire product lifecycle. We design and implement innovative infrastructures thanks to a global service offering as an enabling lever for digital transformation.