CGMP Data Integrity Using PDA TR80 and ALCOA ALCOA+ Infographic

Data integrity issues were cited in 57% of all 2018 FDA warning letters. Are there tools to help you prepare your QC lab data framework to handle this increased scrutiny? The answer is a firm two-step yes.

In August 2018 PDA released Technical Report 80 (TR80): Data Integrity in Laboratory Systems. TR80 can be a new tool in your ALCOA/ALCOA+ toolkit, strengthening your current manual and electronic data support protocols.

Learn the five key elements of TR80 and its integration with ALCOA/ALCOA+ structure. Then see how RMB can help you with Part 2.

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