The main objective of using the Gap Analysis in the pharmaceutical industries is
to identify the gap between the regulatory requirements governing the company operations
and the current status of the company operations. This helps provide the company
with insight into areas that have room for improvement. For this purpose ReguLogix
provide the gap analysis service to determine, document and approve the variance
between requirements and current capabilities. The next step for most companies
is to determine what actions are necessary for them to be in compliance with the
requirements.
Regulogix helps you assess the implemented CSV as against the 21 CFR Part 11 requirements
which provide the industry with assessable information for electronic records and
signatures that can be used to add weightage to the validation of automated systems.
Part 11 regulations can be used to accomplish three tasks: create new requirement
specifications that comply with Part 11 regulations, assess existing automated systems
for Part 11 compliance, and remediate Part 11 compliance gaps in existing automated
systems.
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