FDA and MHRA are going to be focusing on data integrity in 2015 as there have been major issues with raw data during Pre-Approval and general inspections. This issue applies to medical device, in-vitro and pharmaceutical systems.
MHRA states that “Data integrity requirements apply equally to manual (paper) and electronic data. Manufacturers and analytical laboratories should be aware that reverting from automated / computerized to manual / paper-based systems will not in itself remove the need for data integrity controls. This may also constitute a failure to comply with Article 23 of Directive 2001/83/EC, which requires an authorization holder to take account of scientific and technical progress and enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.”
In other words, companies cannot rely on the paper data when they are using computerized systems to generate the data. The guidance document also implies that companies need to move forward with technology and rely less on legacy systems.
The expectation is that data must be ALCOA:
A – Attributable to the person generating the data
L – Legible and permanent
C – Contemporaneous
O – Original (or ‘true copy’)
A – Accurate
Download the guidance document here.