|  21
CFR Part 11 – Are You Compliant?
21 CFR Part 11, the FDA rule governing the use
of electronic records and electronic signatures, is
not a new regulation, yet many organisations are still
failing to comply. Compliance is required from anyone
involved in the development, manufacturing and marketing
of life sciences products, including drugs, diagnostics
and medical devices.
Many vendors claiming part 11
compliance reveal incomplete understanding of the regulation
by not quite achieving all software requirements or
by not fully meeting their customers’ expectations
during vendor audits. This can lead to their customers
in turn failing to be compliant and falling foul of
the FDA. The FDA intends to continue enforcing part
11, specifically as it relates to predicate rule requirements.
Affected organisations, such as pharmaceutical companies,
must comply and are therefore applying pressure on vendors
to develop equipment that is compatible with part 11.
It is imprudent for equipment vendors to delay addressing
the implications this regulation has on their businesses,
as they will only drop behind their competitors and
peers. Duncan Bishop, CCL’s head of regulatory
affairs comments, "From working with many of the
world’s leading biotech and medtech companies,
we have gained extensive experience in the development
of computerised systems for use in a regulated environment.
We appreciate the unique regulatory requirements that
our clients face and can help them by providing integrated
software and regulatory solutions."
Pharmaceutical companies also increasingly want to purchase
equipment with part 11 functionality even when it is
not strictly required. This is either the result of
a "safe not sorry" approach, or a company-wide
data-handling policy, which provides additional benefits
to implementing part 11 over the initial goal of solely
attaining compliance. Equipment vendors are urged to
view providing part 11 functionality and validation
support as an opportunity to differentiate themselves
from their competitors, as putting off attending to
the ramifications of part 11 risks the loss of customers.
Note to editors:
Cambridge Consultants Limited (CCL) designs and develops
innovative new products, processes and systems. CCL
enables clients to turn business opportunities into
commercial successes, whether launching first-to-market
products, or expanding existing markets through the
introduction of new technologies.
With a team of over 200 engineers and scientists, CCL
is able to offer solutions across a diverse range of
industries including healthcare, telecoms, industrial
and consumer products, automotive and aerospace. |
