Data as cGMP Records and Other Integrity Issues: Steps to Make Sure No Data is Forgotten | CPhI North America

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Data as cGMP Records and Other Integrity Issues: Steps to Make Sure No Data is Forgotten

Robert Voelkner (Vice President Sales and Marketing, LabVantage Solutions, Inc)

Location: E353b

Date: Wednesday, May 1

Time: 3:00pm - 3:45pm

Vault Recording: TBD

As one of the most regulated industries, pharmaceutical manufacturers and the laboratories supporting them must keep pace with strict and ever-changing regulations. The 2018 guidance’s from the FDA and MHRA include recommendations that all data becomes a cGMP record and data created and maintained cannot be modified without a record of the modification.

As researchers, scientists, lab managers and others struggle to ensure the integrity of their data, vendors are stepping up with solutions to protect that data.

This presentation reviews how a purpose-built LIMS – one designed for pharmaceutical-specific workflows and compliance – works to ensure the integrity of your data, even temporary data, in labs that support pharmaceutical manufacturing.

Key Takeaways from this Session:

  • Understand the evolving global regulatory landscape relative to data integrity in the lab
  • Learn when data becomes a cGMP record
  • Approaches to LIMS compliance with 21 CFR Part 11 and Annex 11, including Audit Trails for regulatory compliance
  • Approaches to protecting temporary data
  • Questions to ask LIMS vendors regarding data integrity