Data Integrity: cGMP Guidance

Course Overview

This cGMP Data Integrity Compliance Training provides an in-depth understanding of data integrity regulations and expectations from major global regulatory authorities, including:
✅ PIC/S Data Integrity Guidelines (as of the 1 July 2021 publication date)
✅ PIC/S Annex 11 – Computerised Systems (multiple mentions of Data Integrity expectations)
✅ FDA Data Integrity Publications (FDA Data Governance expectations)
✅ TGA Guidelines on Data Integrity in GMP environments
✅ EMA & MHRA Data Integrity Guidance Publications
✅ Common GMP Inspections (GMP Audit Findings) relating to failure to implement appropriate Data Integrity assurances 

Who Should Take This Course?

This Data Integrity (GMP Training course) is designed for professionals responsible for data integrity in GMP-regulated environments, and any person who keeps important records in pharmaceutical manufacturing environments.

This course is suitable for:
✅ Quality Managers & GMP Compliance Inspectors
✅ Laboratory Personnel & GMP Team Leaders/Operations Managers
✅ Site Inspectors, Regulatory Affairs & GMP Auditing Personnel
✅ IT Administrators & Data Security Professionals
✅ GMP Manufacturing & Distribution Personnel
✅ Clinical Trial & Laboratory Researchers
✅ Pharmaceutical & Medical Device Industry Professionals

Key Learning Topics

📌 Regulatory Guidance on Data Integrity & Data Governance – FDA, EMA, MHRA, TGA, WHO, and PIC/S
📌 Data Risk Management & Prioritization – Identifying and mitigating data risks
📌 IT Security & Computerised Systems Compliance – User authentication, access controls, and data protection
📌 Paper vs. Electronic Records & Digital Signatures – ALCOA+ principles and documentation compliance
📌 User Access & Authentication Controls – Logins, passwords, and remote access requirements
📌 Management & Cultural Influences on Data Integrity – How organisational culture impacts compliance
📌 Data Lifecycle & Retention Periods – Storage, retrieval, and archiving of GMP records
📌 Systems & Controls for Data Integrity in Manufacturing – Preventing data manipulation and fraud
📌 Recordkeeping & Documentation Practices – Good Recordkeeping Practice (GRK)
📌 Corrections & Approval Processes – Managing record changes and error handling
📌 Data Integrity in Laboratory Environments – Preventing scientific fraud and ensuring accuracy

Note: Good Recordkeeping Practice (GRK) is also referred to as Good Documentation Practice (GDocP). Detailed GMP compliance training in relation to Good Recordkeeping Practice/Good Documentation Practice is available from the online GMP training store.

Why This Course is Essential for GMP Compliance

Ensuring data integrity is a critical component of regulatory compliance in GMP environments. This course provides essential training to help organisations:
✔️ Understand regulatory expectations for data governance in regulated facilities
✔️ Implement effective data risk management strategies
✔️ Strengthen IT security and access controls for GMP records
✔️ Ensure compliance with FDA, EMA, MHRA, TGA, PIC/S, and WHO guidelines for data integrity

Flexible Online Learning Format

This self-paced eLearning course allows participants to:
✔️ Access course materials anytime, anywhere (valid for 12 months from date of purchase)
✔️ Learn at their own pace with real-world Case Studies & Data Integrity warning letters
✔️ Combine online learning with instructor-led training options (virtual or onsite, where available)

This course is ideal for professionals working in pharmaceutical manufacturing, medical device industries, laboratory environments, and clinical research settings. It is suitable for anyone who needs to understand the importance of ensuring accurate, reliable data (and ALCOA+ data) and its role in product quality and patient safety.