The
U.K. Medicines and Healthcare products Regulatory Agency have issued a new
guidance document relating to data integrity.
The
way in which regulatory data is generated has continued to evolve in line with
the introduction and on-going development of supporting technologies, supply
chains and ways of working. Systems to support these ways of working can range
from manual processes with paper records to the use of computerised systems.
However the main purpose of the regulatory requirements remains the same; having
confidence in the quality and the integrity of the data generated and being
able to reconstruct activities remains a fundamental requirement.
Posted by Dr. Tim Sandle
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Pharmaceutical Microbiology