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Quality control and validation
Ideal partner for experimental products
EN-COM is a partner for Pharmaceutical production companies whose business purpose is to create medicinal products and products for clinical trials.
Quality Assurance & Validation
The QA Validation unit provides support in the drafting, reviewing and managing of the following GMP documentation:
- Project Validation Summary and Validation Plan
- Protocols and Qualification Reports (IQ/OQ/PQ)
- Protocols and Qualification Reports for aseptic filling processes (Media Fill)
- Protocols and microbiological qualification reports of classified areas
- Protocols and Qualification Reports of process gas
- Protocols and Qualification Reports of distilled water (WFI) and purified water (PW) distribution systems
- Process and/or validation phase deviations
- Management and implementation of CAPAs
- Project Changes
- Technical Reports
- Quality Review
- Risk Assessment, FMEA
- Sterility Assurance Assessments
- Standard Operating Procedures (SOPs) and Work Instructions
- Preparation of documentation to be submitted to Inspection Bodies (FDA/AIFA, etc.)
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Services
do you need anything else? Let's talk about it!
We seek to connect with our customers beyond the traditional design and development agency relationship by becoming a development partner
To have an opinion on an existing project.
Tell us about your situation
+39 0524 688078
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info@en.com.it