Regulatory Compliances Services
Knowledge. Experience. Expertise.
When it comes to validation, experience is not the only criteria. In -depth knowledge about the pharmaceutical industry, how plants function and what are the regulatory requirements, count more.
Whether a project involves consulting or validation services for a single system, a unit operation or an entire facility, Kevin has the knowledge and experience to provide the required assistance. Our portfolio of services encompasses the entire product life cycle and includes GMP Compliance services, validation services and projects requiring the integrated services of both these services.
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Computer System Validation
More Security at low cost
Kevin is committed to a defined strategy that will lower the cost of development and support for computer system that need validation. This commitment includes the development of validation Models, Qualification protocols and necessary training materials for you.
We will continue to educate our validation experts on only the technological advances of advances of application software & security related tools, but on the newer guidelines such as the GAMP and the 21 CFR part 11.For you this will translate into more updated information and a partner who is trained in various related technologies & regulatory requirements.
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21 CFR Part 11
Built-in security authentication and much more
Kevin's commitment includes the development of 21 CFR part 11 applications where the following functions will be addressed:
• Built-in security authentication from a Windows NT domain where the configuration is effectively
transparent to the user, if he selects to use NT authentication.
• The ability to report easily on application changes and to do comparisons in order to reduce FDA
validation and maintenance costs.
• These functionalities are and will be available in most of our systems enabling existing application to
be continuously going forward and permitting enhancements to be made to applications with
reduced effort for achieving 21 CFR part 11 compliance.
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Clinical Research Lab Equipment Validation
Coming Soon...
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