New Webinar: Why Is Data Integrity Important in GxP-Regulated Laboratories?

Share Article

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.

GXP Data Integrity Webinar
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.

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" [1].

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 here.

[1] MHRA,Guidance for Industry on Data Integrity 2015

About METTLER TOLEDO
METTLER TOLEDO is a leading global manufacturer of precision instruments. The Company is the world’s largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. The Company also holds top-three market positions for several related analytical instruments and is a leading provider of automated chemistry systems used in drug and chemical compound discovery and development. In addition, the Company is the world’s largest manufacturer and marketer of metal detection systems used in production and packaging. Additional information about METTLER TOLEDO can be found at http://www.mt.com.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Branko Radovinovic
METTLER TOLEDO
+41 44 944 20 39
Email >
@mettlertoledo
since: 03/2012
Follow >
METTLER TOLEDO
Like >
Mettler-Toledo International, Inc

Visit website

Media

GXP Data Integrity Webinar