Life Sciences, GAMP Templates

Leveraging EnteGreat's extensive library of compliance and GAMP content has enabled our clients to accelerate business performance improvement initiatives in a cost effective manner. This content, in the form of methodologies, models, and templates covering all aspects of GAMP-based system lifecycle activities, provides a mature foundation for addressing all levels of regulatory requirements across planning, design, testing, training, and documentation. EnteGreat's library of compliance and GAMP content has been accumulated and refined through years of client projects spanning all aspects of full-systems lifecycle coverage. These templates have been the basis for numerous systems deployed in various production domains which have successfully withstood internal and external auditory reviews.

Additionally, EnteGreat has developed GAMP-based system module level design and testing documentation that accompanies our library of compliant manufacturing best practices for extending SAP to the shop floor (Compliant Manufacturing Framework^® ). These templates, which match the associated configurable software modules enable EnteGreat clients to dramatically compress their system lifecycle timeline.

• Compliant Training and Documentation
• Comprehensive Coverage
• Knowledge Transfer
• Proven Content
• Applicability to various Life Science manufacturing domains (API/Chem, Secondary solid dose pharma, Secondary liquid dose, packaging, biotech, medical device).

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