GAP Analysis Service
ONG Automation application and validation engineers can partner with you to audit and analyse your automation systems for GxP compliancy, including 21 CFR Part 11.
We can consult with you to make quality validation improvements,
from developing new automation functions to improving your overall quality process.
ONG Automation has the experience and qualifications to assess the tools, policies,
procedures, and controls you have in place for the development and implementation of
automation systems within the GxP environment.
Our experienced engineers are trained to evaluate your automation systems and associated procedural
documentation against the applicable regulatory requirements. Each gap analysis is conducted using
our proven methodology that weighs the risks, benefits, costs as well as your business objectives.
Some of the areas we focus on include:
| • Identification of areas, equipment, and systems that require compliance |
| • The impact of the regulation on the client's operations |
| • Our client's regulatory compliance objectives |
| • Review of client procedures |
| • Analysis of procedural documentation, validation and GAP data |
| • Regulatory significance and impact on the client |
A GAP analysis report is given to the client at the end of an assessment and will
include information about:
| • Applicable regulations and guidelines |
| • Level of compliance |
| • Areas of risk - including strengths and weaknesses |
| • Remedial plans and potential timetables |
In addition, ONG Automation can support you with automation system process qualifications,
provide you with a turn-key solution for initial validation in preparation for pre-approval inspections,
and provide remediation and revalidation services.
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