Course Summary

Pharmaceutical and biotechnology companies and researchers need to assure regulatory authorities of the reliability of the data that they generate or acquire during product development and manufacturing – that is, to demonstrate data integrity. Data integrity is assessed during regulatory inspections of manufacturing and research sites. Inadequacies of data integrity are frequently reported by inspectors and result in regulatory actions against the companies or individuals concerned.

Practices that assure data integrity are required by law and/or expected by regulators in the fields of nonclinical and clinical research, manufacturing and distribution, and pharmacovigilance of medicinal products. This course explains the requirements and describes principles and practices that should be followed to assure regulators and contractual partners of data integrity in the manufacture of medicinal products.

Who will benefit from this module?

Everyone who works in, or has occasion to enter into, a manufacturing environment in the pharma/biotech industry should have access to this module.

Learning Objectives

• Define fundamental concepts of data integrity and outline how they are applied in manufacturing
• Identify failures of data integrity that may be found by regulatory inspectors, and the unacceptable practices that give rise to them
• Comply with legal requirements and regulatory expectations concerning paper-based data
• Comply with legal requirements and regulatory expectations concerning electronic data

Module Outline

Key topics covered in this module include:

• Data integrity definitions and fundamentals

What do we mean by data?; What is data integrity?; ALCOA and ALCOA+; Raw data and metadata; Transcription and transformation of data; Static and dynamic data; True copies; Archiving and retention; Validation of computerized systems; Data governance; Key questions to answer; Unacceptable practices; Regulators’ responses to data integrity failings

• Integrity of paper-based data

Control of paper-based data; Recording data on paper; Making handwritten corrections; Verification of records (secondary review); Signatures and delegation; Storage, archiving and retention of paper records

• Integrity of electronic data

Restrictions on access to computerized systems; Data entry/capture; Audit trails; Review of data; Protection of data; Storage, backup and archiving; Data transfer and migration; Electronic signatures; Reporting, investigation and correction of data integrity issues; Outsourced activities

• Assessment - Multiple-choice assessment.