New webinar highlights importance of data integrity in GxP-regulated laboratories

Oct 6 2017

Data integrity is a hot topic for regulators and auditors, making it important to understand data integrity criteria for the laboratory – and apply the principles correctly. A free on-demand webinar from METTLER TOLEDO provides tips to improve data management processes and address any weaknesses, so as to ensure compliance with current regulations.

As regulators continue to tighten their inspection approaches, it is critical for managers and scientists in regulated laboratories to understand the key issues surrounding data integrity and be able to demonstrate compliance. METTLER TOLEDO is offering a free on-demand webinar entitled “The Importance of Data Integrity in GxP Regulated Laboratories", presented by independent experts Bob McDowall and Isabelle Mattmann.

What is data integrity?

Data integrity can be defined as "the extent to which all data are complete, consistent and accurate throughout the data lifecycle".

This 45-minute data integrity webinar explains:

• The definition of data integrity according to regulatory bodies.
• Current regulatory guidance issued by FDA and MHRA and inspection trends.
• How to use the ALCOA+ criteria to ensure data integrity in the lab.
• What practices to avoid, using examples of regulatory citations for non-compliance.
• What should be assessed: for example, 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.

Why is data integrity important?

Data integrity is a critical component of pharmaceutical product quality and the submission of information to regulatory agencies, which is designed to ensure the safety, efficacy and quality of drugs and protection of public health. 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.

Yet in recent years, increasing numbers of inspections are resulting in citations and warning letters for data integrity infringements, such as incomplete data, lack of audit trails and falsification of results. Avoid non-compliance with data integrity guidelines by watching the webinar.