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•  Project Management

Requirement gathering
GAP analysis
Design and installation of Supporting
Computer Infrastructure (SCI)
Development of a comprehensive
project plan
Data conversion and data loading services
Data transport throughout the SAP
environments
Design and development of Change
Control processes
Integration with other computerized
systems such as Oracle, Peoplesoft, Siebel, and MAXIMO
Knowledge of middleware products such
as BEA Weblogic and IGM Websphere
Experience with Oracle and SQL
database utilities
Creation of backup/restore and disaster
recovery procedures
Creation of custom reports using
industry-standard applications such as Crystal Reports

•  An integrated team approach to facilitate accurate and timely production of validation test methodologies and documentation

•  GMP assessments and 21 CFR Part 11 templates to assist in identifying and prioritizing processes for validation

•  Risk Assessment and Remediation

•  Full 21 CFR Part 11 Assessment to ensure compliance - identification of transactions and tables used in eAudit and eSignature processes and setting on table logging to capture this information

•  Experience implementing the optional SAP Pharma-Pack produce enhancement module that is used for satisfying the requirements of CFS 21 Part 11

•  Compliance and logical consistency review of full Validation documentation including URS, FRS, Unit test plans, IQ test plans, OQ test plans, PQ test plans

•  Review and audit of highly complex tractability matrices in order to ensure accuracy

•  Partnering with business process owners to ensure that the SAP system meets or exceeds user requirements.

•  Full support of the System Development Life Cycle in order to meet both compliance and business requirements.

Fields of Expertise