The Certified ALCOA+ Data Integrity Compliance Specialist course, offered by CDG, is a comprehensive, self-paced online certification program meticulously designed for professionals who are involved in regulated environments such as pharmaceuticals, biotechnology, clinical research, manufacturing, quality assurance, and laboratory operations. This course provides an authoritative and practical understanding of ALCOA+ principles, international data integrity expectations, and compliance frameworks that support trustworthy, transparent, and audit-ready data across the product lifecycle.

In today’s regulatory landscape, maintaining data integrity is not simply a compliance requirement—it is the foundation of product quality, patient safety, and organizational trustworthiness. With global regulatory bodies such as the FDA, EMA, MHRA, WHO, and PIC/S continually raising the bar on data integrity, organizations must ensure their teams are not only aware of these standards but fully equipped to implement them. The ALCOA+ framework (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) is the global benchmark for data integrity compliance. Mastery of these elements is essential for any professional working in a GxP-regulated or data-driven environment.

CDG’s Certified ALCOA+ Data Integrity Compliance Specialist program offers a structured pathway for learners to gain both theoretical insights and practical tools to embed ALCOA+ values in everyday operations. Whether you are part of a quality assurance team, involved in IT validation, working as a clinical investigator, or managing data systems and records, this course empowers you to understand your responsibilities, identify risks, apply controls, and uphold the highest standards of good documentation and record management practices.

One of the key strengths of this course is its flexible self-study format, allowing learners to engage with the content at their own pace, from anywhere in the world. Designed for working professionals, the course is accessible 24/7 via our dedicated learning platform. Learners can progress through the material in a sequence that suits their schedule while receiving structured guidance and real-world examples to ensure full comprehension of the content.

This course goes far beyond generic training—it delves deeply into what ALCOA+ means in practical terms, and how it influences data collection, processing, review, storage, and reporting across various systems including paper-based, hybrid, and fully electronic environments. The material is aligned with the latest guidance documents, including FDA’s Guidance on Data Integrity and Compliance with cGMP, MHRA’s GXP Data Integrity Guidance, WHO Technical Report Series (TRS) Annexes, and industry-recognized best practices.

Participants will explore how data integrity intersects with quality culture, risk management, system validation, audit trails, deviation handling, change control, access controls, and employee training. Each concept is explained with reference to real compliance scenarios and case studies, enabling learners to link regulatory expectations with operational execution. The course also emphasizes the importance of data governance and organizational accountability, making it especially valuable for managers, team leaders, auditors, consultants, and senior quality professionals.

Another distinguishing feature of this program is the final online exam, designed to objectively assess a candidate’s understanding of ALCOA+ principles and their ability to apply them in real-world settings. The exam includes scenario-based questions to test both conceptual knowledge and decision-making ability in compliance situations. Learners can take the exam at a time convenient to them. Once the exam is successfully completed, an official certificate is generated instantly through our secure platform. This certificate can be downloaded, printed, or verified online, offering a recognized credential that demonstrates competence and credibility in data integrity compliance.

By the end of the course, certified professionals will be able to:

• Interpret and apply each of the ALCOA+ principles to data handling processes
• Evaluate and mitigate data integrity risks in laboratory, manufacturing, and clinical operations
• Participate in audits and inspections with a clear understanding of data integrity expectations
• Implement data lifecycle controls in alignment with international regulatory guidance
• Contribute to building a quality culture where data integrity is consistently prioritized and enforced
• Demonstrate competence to stakeholders, employers, and regulatory agencies through certification

The Certified ALCOA+ Data Integrity Compliance Specialist course is suitable for:

• Quality Assurance and Quality Control professionals
• Regulatory Affairs and Compliance personnel
• Manufacturing and Production staff in GxP-regulated industries
• Laboratory analysts and data reviewers
• Clinical research associates, data managers, and investigators
• Computer system validation and IT professionals supporting regulated systems
• Consultants and auditors specializing in GxP and quality compliance

This course reflects CDG’s commitment to accessible, high-quality online education that meets the evolving needs of compliance professionals across the globe. It provides a solid foundation as well as advanced insights into how ALCOA+ principles are applied across a variety of roles and systems. Whether you are just entering the field or looking to deepen your expertise, this certification signals your readiness to handle data integrity responsibilities with confidence, precision, and regulatory alignment.

Enroll in the Certified ALCOA+ Data Integrity Compliance Specialist course today and take a decisive step toward enhancing your professional credibility, ensuring organizational compliance, and contributing to a culture of transparency and excellence. With CDG, your journey toward certification is flexible, engaging, and fully aligned with the demands of global regulators.