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Part 11 Information

 
 

Perrin Consulting - perrin-consulting.ch

Basil, Switzerland-based company providing services in the areas of clinical information technology and validation of regulated GxP computer systems

perrin consulting quality management pharma pharma consulting 21cfrpart11 21 cfr part 11 part 11 it project it project management system intergration data migration drug safety drug safety system gmp glp gcp gxp validation computer validation computerized system validation business process analysis

 

PocketPharma - medc.se

Offers a mobile system for patient diaries and quality of life questionnaires within clinical trials

pocketpharma medc ab pocket pharma medc mobile edc mobile edc electronic data capture electronic data capture edc system system elektroniska patientdagbok dagbok handdator livskvalitet cdisc odm xml

 

The CRO Group Inc. - crogroup.com

Medical device, IVD, and biotechnology consulting in quality, regulatory, safety testing, clinical investigations, reimbursement, export, compliance, approvals, ISO9000, EN46000, ISO13485 certification, CE Marking, 21CFR820, 21CFR812, authorized representative, software-qa, mdr-vigilance, and ipo-venture capital audit preparations

iso 13485 cmdcas ivd directive 510k en 60601-1-4 21 cfr 11 21 cfr 812 21 cfr 820 part 11 eu authorized representative fda us agent technical files quality systems safety testing 93-42-eec 98-79-ec

 


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