CGMP / IT FDA APPROACH
Detecting required compliance
We identify the applicable requirements (defined for example in laws, regulations, contracts, strategies and policies), assess the state of compliance, assess the risks and potential costs of non-compliance against the projected expenses to achieve compliance, and hence prioritize, fund and initiate any corrective actions deemed necessary.
CGMP/IT FDA Compliance Assessment
Our ultimate goal is to assess your organization’s compliance with the general rules, identify gaps and provide you with detailed recommendations to effectively close those gaps and ultimately protect your business. We will by provide your organization with a compliance assessment report (FDA/ COFEPRIS/ ISO) outlining all gaps along with a detailed roadmap to achieve ultimate compliance.
CGMP/IT Risk Based Assessment (GMP/IT RBA)
Our specialists will evaluate with a RBA point of view, all your GMP/IT infrastructure, since your hardware and software, until your IT organizational frame and GITP (Good IT practices), passing trought communications, security & safety, and your DRP. Even, and depending on your industrial sector, we can evaluate your IT department based on GAMP (Good automated Manufacturing Practices).
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