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Epitome
provides enterprise-wide technology and compliance solutions to regulated
industries in the Life Science Sectors. The firm delivers a comprehensive
suite of Computerized System Validation, Technology, Regulatory and
Business solutions and services. In addition to expertise in software
validation/QA, our team has the knowledge of FDA regulations and the
experience in applying best practices to help pharmaceutical companies
meet their quality and compliance goals methodically and
cost-effectively.
Our
professional services include GAMP 4 based Computer System Validation
(CSV), 21 CFR Part 11 compliance, Manufacturing Automation, Integrated
Quality and Compliance management Solutions and support for virtually all
other aspects of software quality assurance and testing. We apply risk
analysis throughout each engagement to establish practical priorities
consistent with business objectives and regulatory guidelines.
Epitome’s
experience spans a wide range of Pharmaceutical Information Management
Systems, Manufacturing systems (including PLCs and SCADAs), Laboratory
Systems (including HPLCs, GCs and FTIRs), Quality Systems (e.g. LIMS),
and business/enterprise systems with GxP sensitivities ,including ERP
Systems such as SAP R/3 Validation.
Epitome
has a rich experience of delivering the Project Objectives
to the utmost satisfaction of the customer. Due to our high tech Resources and Facilities we get Repeat
Business, from our existing customers and the
continuously expanding client base.
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