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Wayne, PA, July 8, 2010 - At DIA 2010 in Washington, DC, Novartis Consumer Health process development manager Jim McElroy presented a case study on his facility’s move to a paperless cleaning validation environment.

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21 CFR Part 11, GxP Technology Compliance and Computer Validation Solutions

 

 

 

ValiMation is a great choice for computer system validation. They are knowledgeable, responsive and provide value to our compliance program.
Jim McElroy, Manager, Compliance Engineering
Novartis


ValiMation provides technology, compliance and validation solutions for GMP, GCP and GLP applications used in pharmaceutical and biotechnology industries. We specialize in 21 CFR Part 11 solutions that span process automation, lab automation and IT.

Our collective expertise in technology, processes and compliance helps us provide high quality, cost effective and pragmatic solutions to our clientele.

Validation and Compliance Services

21 CFR Part 11 Practice IT Infrastructure Qualification Practice
Our Part 11 portfolio encompasses corporate wide strategy to risk management to design/validation of individual applications.
Our unique knowledge of current IT technologies and compliance enables us to provide an effective, standards based IT network infrastructure qualification program.
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GMP/GLP/GCP Validation Practice Compliance Consulting &
Auditing Practice
We are the technology validation experts. We validate computerized applications utilized in Laboratory, Manufacturing, Clinical and Preclinical areas.
We can design and implement compliance frameworks, policies and programs to meet all your GxP needs.
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Vendor Solutions
We provide equipment / software vendors catering to the life science market with 21 CFR Part 11 and validation services to ensure their products stay relevant and compliant.
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Systems Integration

Business Process
Automation
Plant Automation
We accelerate the business processes of a life science company by implementing applications based on the robust Microsoft .NET architecture.
We deliver turnkey plant automation solutions using the latest technologies in engineering and controls.
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ERP Systems Traceability Solutions
We deliver ERP implementation solutions with integrated validation using a ‘govern and flow’ based delivery model.
We implement traceability solutions by implementing industry leading Requirements Management solutions to our life science clientele.
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