Global Compliance Services
SOP Creation/Review
Quality Policy/Manual
We provide actionable compliance advisory services that drives the education and awareness into audit-able compliance documentation.
We focus on the development, edification and enforcement of GxP Computer System Validation and Quality by Design methodologies ensuring FDA-GMP/GLP/GDP/ISO/SOX conformity of Quality Systems in the Pharmaceutical, Nutraceutical, Biotechnology, and Medical Device segments.
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We can help your organization build a quality policy that is the foundation of professional expertise delivering quality services and products as the baseline standard.
A corporation will mature and learn more over time. Our experience will help you realize how mature your organization is by the level of effectiveness with your quality systems policies and procedures. documentation and the
Computer System Validation (CSV)
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A pragmatic risk-base approached to CSV is often very complex on assessment but reduces your cost of compliance by focusing on the more regulated parts of the system.
Test Management
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Enterprise and Project Test Management is a very profound source of or costs for any Organization. You need to learn from those have have a very aged maturity model and understood the pains and costs of maturation. We can provide some of the wisdom and guidance from numerous organizations and implementations.
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The standard procedures that support your Quality System are just as important as the raw materials you source into your finished products.
Do not allow and audit to give your observations, 483s or a consent decree. The cost of Remediation is much more costly than proactive quality initiatives.
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GxP Audits
It is very crucial to have internal and external GxP Audits performed annually and during major Phase gates on new system implementations. risk-base approached to CSV is often very complex on assessment but reduces your cost of compliance by focusing on the more regulated parts of the system.
Work Instructions
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How do your workers know how to perform their job according to training requirements? We sure to document your work instructions as a part of your quality system and ensure your resources have training records providing documented evidence they are trained to perform their functions.
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