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Stelex can help you define and complete your validation projects on time and within budget through our services and enterprise solutions. With global experience including projects in the USA, Canada, EMEA, and Asia-Pac, Stelex leverages its extensive experience to cover all of your GxP and other compliance standard needs.
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Experience Efficient Business Processes - As project scope increases/decreases, Stelex turns around quickly with a smooth scaling up or scaling down response.
Collaborate with Dedicated, Highly Experienced Consultants - Our employees are renowned for their domain experience, practical understanding and implementation ofregulatory requirements. Stelex consultants have an average of 10+ years of expertise in Validation. Stelex Compliance Services Key FactsValidation and qualification services have been core competencies of Stelex since the company’s inception in 1977. Your Validation specialists have completed over 500 validation projects.
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Stelex consultants have extensive experience with FDA regulations and in the mitigation of risk for companies of www.website-designing-company.com all sizes. All projects utilize industry best practices in methodology and deliverables.
Our support begins with assigning a group of highly qualified and experienced consultants to your project. We staff projects based on required expertise and scope, providing the most efficient and cost effective Computer System validation services possible, including:
System Requirements and Design:
• User Requirements Specifications (URS)
• Functional Specifications (FS)
• Design Specifications (DS)
• Design Review
• Supplier/Vendor Audits
System Development and Verification:
• Leveraging of Vendor Documentation
• Unit Testing
• Integration Testing
• System Testing
• Site Acceptance Testing (SAT)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Requirements Traceability
• Data Archiving
• Continuity Planning
• Change and Configuration
• Incident and Problem Management
• Periodic System Reviews
• Best Practices Training
System Type Expertise:
• Enterprise Systems including CRM, ERP, EAM, and SFA.
• Laboratory Systems including
Laboratory Operations (R&D, QA/QC)
• Quality Systems including CAPA, Data Management, Clinical Trial Applications, and Sharepoint.
• Pharmacovigiliance and Medical Information Systems