Product and Educational Services LLC ("PES")
Located in the PA Biotechnology Center, Doylestown, PA 18902
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Distribution
Quality System Consulting
Sterility Assurance
FDA Regulatory Affairs
ISO 13485 and CE Marking
Clinical Trial Support
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Quality System Procedures
Design Controls
Computer System Validatio
CAPA Investigations
Risk Management
Quality Audits
Corporate Leadership
Computer System Validations
PES provides consulting services for validating computer systems and applications by:
Managing Validation Projects
Reviewing Product Specifications and User Requirements
Writing Validation Plan
Writing IOQ Protocols and Test Scripts
Writing User Acceptance Qualification Protocols and Test Scripts
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