| Hansoft
is a recognized global leader in providing computer systems
validation and regulatory compliance services for the
pharmaceutical, biotechnology and healthcare industries.
Our work with computer and automated systems, including
compliance with the U.S. FDA’s 21 CFR Part 11, is
well known throughout the industry. Hansoft resources
encompass a broad range of compliance expertise with most
major manufacturers.
Hansoft has a dedicated group of pharmaceutical engineers,
consultants and specialists focused on this industry,
regulations and new technology tools. Our services include
a full range of products, automated tools, validation
services (VTI) and procedures to help enable compliance
to 21 CFR part 11 and the EU Annex Part 11. We leverage
our expertise to provide systems, tools, policies and
procedures for compliance.
Hansoft has validation expertise and experience with
all types of computer systems across the enterprise,
including manufacturing, packaging systems, laboratory
systems, clinical trial systems, and information technology/
business systems. Our expertise includes the development
of global standards and methodologies across the supply
chain.
Through the use of risk analysis tools, we can define
the scope and focus of your computer system validation
effort. Defining and justifying the end point of each
computer system validation project is key to managing
the scope and thereby the project plan of computer system
validation. Hansoft has broad experience in system validation
across the supply chain.
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