Tuesday, 4 August 2015

Good Manufacturing Practice (GMP) data integrity


"Good Manufacturing Practice (GMP) data integrity: a new look at an old topic". On the MHRA website David Churchwood has written an article about the GMP aspects of electronic data systems and security.

Here is an excerpt:

"In addition to staff training and implementation of data integrity policies, consideration should be given to the organisational (eg procedures) and technical (eg computer system access) controls applied to different areas of the quality system. The degree of effort and resource should be commensurate with data criticality (how it is used) and inherent risk (how it is generated)."

The article can be accessed in full here.

Posted by Tim Sandle