Services
We offer management consultant services to a diverse range of clients in various industries. Some of our important practice areas are listed below.
Audits
We specialize in audit services for internal application development and external application vendors, computerized systems, data services, data centers, SaaS and external vendor qualification to FDA 21 CFR Part 11, EU GMP Annex 11, and GxP (GCP/GLP/GMP) global regulations. We perform Qualification audits of PQ packages for end users OQ packages for application vendors, and IQ packages for data centers.
Consulting
We help organizations establish a scalable computer compliance strategy starting from corporate policy through to regulatory inspection-ready packages. Our mentoring and coaching inspires computer validation projects across end user, data center and application supplier activities.
Other Services
We help you with first developing Corporate Policy on computer system validation CSV and then performing the actions at the system/project level. Available interactive CSV training is customized for all levels staff base on designated responsibilities of the target audience. Group Working Sessions produce real customized documentation based on client needs for GxP (GCP, GLP, GMP) or Part 11 compliance.
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