Information Systems Risk and Compliance Consultant, Computer Systems Validation Consultant, Computer Systems Validation Consultant

General Electric Healthcare Italia (Milan)
(http://www.gehealthcare.com/itit/index.html)
Responsible for the Compliance Assessment and remediation of the Italian ERP
and General Ledger system for the Diagnostics Division to meet both GxP and




Financial Regulations requirements.
Accountable for the assessment, planning and execution of the project.

Wyeth Europa ( www.wyeth.com ) - now part of the Pfizer Group of companies
Maidenhead, Berkshire (United Kingdom)
Responsible for the rollout of the Wyeth Product Dossier Management System,
within their European Product Compliance initiative, across four countries in
Europe.
Product was based on a front-end application using the Documentum engine for
management of product dossiers (CMC section for manufacturing plants and
promotional materials for Commercial affiliates)
Duties included: Business Change Management activities and Deployment: End
User Acceptance (Assessment, planning, Acceptance Testing script authoring,
users training in validation, site Validation co-ordination), SOPs regulatory
assessment, authoring and reviewing, local and regional Validation Reporting,
system handover.

Fisher Clinical Services, UK (www.fisherclinicalservices.com )
Horsham, West Sussex (United Kingdom)
Responsible for the validation of the IVR (Interactive voice response system)
Customised Clinical trial database systems: From requirements through
commissioning systems to customers for clinical trial materials management.

Manager of a group of 5 software engineers and software testers.
Responsible for the validation of the IVR platform according to industry and
regulatory standards, acting as regulatory business owner.
Responsible for the implementation of Requirements Management System
software for traceability.
Representative of the IVR division of Fisher Clinical Services in customer and
regulatory audits.

Contemporary Solutions (Csols) PLC (www.csols.com )
Runcorn, Cheshire (United Kingdom)
Responsible for the development lifecyle and deployment of a LIMS system
for Bristol-Myers Squibb, across two Italian manufacturing sites (one of them the
largest in Europe for that Company) and one in Spain. Role included: Technical
assessment of the QA structure, LIMS Business and Regulatory Requirements
Gathering, Software Requirement specifications, compliance assessment, site
project planning for deployment and budget, execution and monitoring, training




planning and execution, system configuration, legacy system decommission, data
migration (analysis, scrubbing, transformation and verification), and validation.

Information Technology Consulting Services
KMI, a division of PAREXEL International, LLC ( www.parexel.com )
Denham, Uxbridge
Responsible for computer system validation activities within the Pharmaceutical,
Biopharmaceutical, Medical Device, and other regulated healthcare industries to
support quality assurance activities and satisfy regulatory requirements.

Summary: Primary activities include Installation, Operational, and Performance
Qualification preparation and execution, compilation and analysis of raw data and
test results, and preparation of final reports. Additional activities include, but are
not limited to, the preparation and review of other validation deliverables such as
User Requirements, Functional and Design Specifications, procedures for the
design, development, implementation and maintenance of computer systems, 21
CFR Part 11 assessments, and software quality assurance and development
methodology implementation.
KMI/Parexel is a worldwide recognized company for delivering GxP compliance
services.

Key assignments :

* Data Trial (U.K.) : Supplier quality assurance assessment and Compliance
achievement programme.
* Genta, Inc. (U.S.): Data verification and migration assessment for a clinical
trials multisite system (70 countries).
* AstraZeneca (Caponago, Italy) : LIMS upgrading and re-validation project.
Business, system and regulatory Requirements re-definition, compliance
assessment, Functional specifications, Qualification and testing planning
and execution, Validation report and release to production.
* Abbott Medisense UK : Review of the Quality Management System for
Software Development to ensure alignment to 21CFR820 and ISO 13485,
as well as company and industry standards.

Validation and Compliance Services, S.r.l. on behalf of Cilag AG
Schaffhausen, Switzerland




Validation process and GMP-GLP compliance of Cilag AG Quality Control
Chemical and Research and Development laboratories responding to their
acquisition by the Johnson and Johnson Group of companies.
* Computerized Laboratory System Validation management and execution
* Compliance assessments and remediation.