Data Integrity webinar - GXP Regulated Laboratory
Data integrity is a hot topic for regulators and auditors, so make sure you understand the criteria for data integrity (ALCOA+) by following our data integrity webinar and applying them to your laboratory. Avoid the risk of incomplete data, lack of audit trails, and falsification of results occurring during inspections.
What will I learn from data integrity webinar?
- The definition of data integrity according to regulatory bodies.
- Current regulatory guidance issued by FDA and MHRA and inspection trends.
- How to use criteria (ALCOA+) to ensure data integrity in the lab.
- What not to do, using examples of regulatory citations for non-compliance.
- What should be assessed, and what constitutes raw data when a computerized system is involved?
- Practical advice and recommendations on how to improve data management processes and address data integrity weaknesses in a typical laboratory, using solutions such as LabX software.
What is data integrity?
Data Integrity definitions:
- The extent to which all data are complete, consistent and accurate throughout the data lifecycle. (MHRA, 2015)
- The degree to which a collection of data are complete, consistent and accurate. (FDA, 1995)
Why is data integrity important?
Data integrity is a critical component of pharmaceutical product quality and the submission information to regulatory agencies. In recent years an increasing number of inspections have revealed incomplete data, lack of audit trails, and falsification of results.
The US Food and Drug Administration (FDA) issued a stern warning that data integrity was a key focus of its enforcement efforts in July 2014. The UK Medicines and Healthcare Products Agency (MHRA) went further and issued GMP Data Integrity Definitions and Guidance for Industry in January 2015.
As regulators continue to tighten their inspection approaches, it is critical for managers and scientists in regulated GXP laboratories to understand the key issues surrounding data integrity and be able to demonstrate compliance.
This data integrity webinar will be of interest to:
- Anyone concerned with understanding the importance of data integrity in the audit process
- Managers and scientists from analytical development laboratories and quality control
- Quality assurance personnel
- Contract research (CRO) and contract manufacturing organization (CMO) laboratory staff and QA personnel
- Compliance managers and regulatory affairs managers
- GMP and CMC consultants, GLP auditors, and quality consultants
- Laboratory managers, laboratory supervisors, and production managers
- Auditors (internal and external) responsible for assessing laboratory quality and data integrity