| As a leading supplier of the Food
& Drug manufacturing industry, ACT'L is familiar with the
specific regulations of the 21 CFR part 11 standard issued by
the US-based Food & Drug Administration (FDA). One of the
basic requirements of the FDA is to maintain and submit records
associated with the products they manufacture. These records
contain information about the product as well as hand written
signatures of the individuals who executed the process and/or
authorized the execution.
Historically, these records have been kept in paper format
and submitted for review to the FDA auditors upon request.
As computer systems became readily accepted in the manufacturing
environment, however, the storage of these records in electronic
format was explored to see whether maintenance of these records
in electronic format offered volume and cost benefits over
the paper equivalent.
Moreover, ACT'L can provide you all the list of documents
described in the Project Quality Plan as referenced by the
FDA and GAMP recommendations. From project "process flow"
to the project "User & training" manuals. ACT'L
can assume all the project lifecycle steps including the "changes
control" procedures and maintenance.
ACT'L will help you maximizing your project lifecycle when
confronted with FDA-audited environment. You can save a significant
amount of money if our applications integrate functions that
minimize (re)validation work when introducing improvements.
You can rely on ACT'L to identify your FDA-Compliance needs,
perform the analysis, develop, validate and implement the
solution that will achieve your objectives.
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Overview