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iubix.com

Iubix

Iubix - Services and Support to Assure Regulatory Compliance for Pharmaceutical, Medical Devices and Biomedical.

http://www.iubix.com/

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Iubix | iubix.com Reviews
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Iubix - Services and Support to Assure Regulatory Compliance for Pharmaceutical, Medical Devices and Biomedical.
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1 Quality Mangement
2 cGMP
3 GMP
4 GAMP
5 GxP
6 Commissioning
7 Qualification
8 Validation
9 Equipment
10 Computer Systems
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services,compliance,regulatory alignment,quality systems,expertise,quality standards,regulatory prime,equipment,computer systems,standards,project support,examples,team,pharmaceutical,medical devices,biomedical,computer system validation
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Iubix | iubix.com Reviews

https://iubix.com

Iubix - Services and Support to Assure Regulatory Compliance for Pharmaceutical, Medical Devices and Biomedical.

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1

Expertise | Iubix

http://www.iubix.com/expertise

I – klog. Pharma, food, auto. Pharmaceutical, medical devices. Auto assembling, auto supply and manufacturing, chemical, food, pharma. Design for: equipment, controls, automation, process, databases. Installation, integration, training, post-installation and manufacturing support. Architect and implement policies, SOP’s, life cycle documents. Update and upgrade Quality Documents. Author commissioning / qualification documents. Packaging process (including sterilization, filling and labeling).

2

Project Support | Iubix

http://www.iubix.com/project-support

I – klog. Project management and execution of large projects from the incipient idea stage, through design, implementation, installation - qualification - validation, release and verification - retirement. Iubix - RTP, Raleigh-Durham, North Carolina, USA.

3

Equipment | Iubix

http://www.iubix.com/expertise/equipment

I – klog. Equipment, Utilities, CS. ICH / FDA Q9 Quality Risk Management. Q10 Pharmaceutical Quality System. Qualification of Existing Equipment, APIC. ASTM E2500 07, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. Guide To Good Manufacturing Practice For Medicinal Products. APIC: Good Manufacturing Practices For Active Ingredient Manufacturers. Quality Management / Risk Management practices/recommendations:. Iubix - ...

4

Standards | Iubix

http://www.iubix.com/expertise/standards

I – klog. Quality Management – ISO 9000/9001. Medical devices Quality Management Systems – ISO 13485. Medical Devices Risk Management – ISO 14971. Clean Rooms and Associated Controlled Environments – ISO 14644, ISO 14698. Medical device software Software Life-Cycle Processes – IEC 62304. Medical electrical equipment – ISO 60601. Programmable Controllers – IEC 61131. Functional Blocks for Embedded and Distributed Systems – IEC 61499. Enterprise-Control System Integration (Level 0, 1 and 2) – ISA S95.

5

Quality Standards | Iubix

http://www.iubix.com/expertise/quality-standards

I – klog. Quality Management, Quality Systems, Risk Management, Design Controls Standards. ISO 9000/9001, ISO 13485, ISO 14971. ICH/FDA Q9 Quality Risk Management. ICH Q10 PHARMACEUTICAL QUALITY SYSTEM. IMDRF SG4 /GHTF SG3 Quality Management Systems. IMDRF SG4 (GHTF) Auditing. WHO Good Practices For Pharmaceutical Quality Control LABORATORIES. WHO Quality Assurance of Pharmaceuticals. WHO Guideline On Quality Risk Management. GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems.

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I – klog. EXCELLENCE… A measure of satisfaction on all aspects of product realisation. We connect science, technologies, the most advanced engineering approach and infuse projects with novel ideas to outperform requirements and provide over the expectations. We understand and envision patient needs…. And project the essence of QUALITY beyond human satisfaction. Work ethics, competence and professionalism: the tools we offer you to build the PATH from QUALITY to EXCELLENCE!

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