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Inspections by the regulatory authorities in the pharmaceutical industry have become increasingly
stringent in recent years. Regulators are focusing on a fundamental theme: data integrity. They want
to be assured that all relevant events are recorded and are legible and traceable. The FDA has
repeatedly found cases of irregularities within companies that had either not applied robust systems
to reduce patient risks, not improved situations where data reliability could be compromised nor
investigated the causes of data errors. The current requirements are represented by the acronym
ALCOA, which says data must be:
Attributable — who did what and when was it done?
Legible — data must be permanently recorded and readable.
Contemporaneous — data should be recorded at the time the job is done and there should be
references to date and time.
Original — the information is the original registration or a certified copy.
Accurate — there must be no mistakes or modifications without registered corrections.
In addition, the data must be complete (including all replicate or sample reanalysis data), consistent
(coherent application of time reference in the waiting sequence), durable (recorded on worksheets,
lab notebook or electronic media) and available (accessible to audit/ auditing throughout the life of
the record).
The integrity of data generated by regulated pharmaceutical companies and laboratories matters
most, because properly recorded information is the basis for manufacturers to assure product
identity, strength, purity, and safety. The non-compliances found in the integrity of data, leads to
warning letters and regulatory action from the agencies.
Consider the very definition of data integrity: Data integrity is the accuracy and consistency of
stored data, indicated by an absence of any alteration in data between two updates of a data
record. Data integrity is imposed within a system at its design stage through the use of standard
rules and procedures and is maintained through the use of error checking and validation
routines.1
In the R&D landscape, a leading Italian company in the contamination control market, AM
Instruments, has invested heavily in a GMP program. The new concept — My&Clean+ — is for the
automatic disinfection of gloved hands. It solves the two common problems: an automatic system
that can trace all the disinfection operations and at the same time eliminate the risk of cross-
contamination.
Before looking at its features in detail, there are two interesting points from the main guidelines for
glove disinfection to identify.
AM Instruments have created an automatic system for the disinfection of gloved hands. The
My&Clean+ responds to the need and very definition of data integrity, both in terms of accuracy
and consistency of the data and in terms of design. The entire system has been developed in order
to trace, record and manage one of the most delicate operations in a controlled contamination
environment.
The MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 document
provided some prescriptions to design systems in a way that encourages compliance with the
principles of data integrity. Examples include:
UK & Ireland
AB Scientific | info@abscientific.com | www.abscientific.com
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