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 GMP environment. Our experienced engineers are trained to evaluate your automation systems and associated procedural documentation against the applicable regulatory requirements. GAP analysis is conducted using our proven methodology that weighs the risks, benefits, costs as well as your business objectives to ensure compliance.

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