We provide our qualified, technical employees to work at your company site under your supervision in FDA regulated areas. We are experienced in performing the following services.

Systems Selection, Configuration & Implementation Assistance Computer Systems Validation-CSV


 

 FDA Readiness / Mock FDA Inspections / Assessments 21 CFR 11-Electronic Records / Signatures

RBA-Risk Based Assessments and Validation Approaches Lab Systems (CDAS) and Instrument Qualification

Network Infrastructure / Servers / Component / Qualification LIMS Implementation / Validation Services

Sarbanes-Oxley SOX/IT Governance Services Facilities / Utilities /Building Management Systems Validation

ERP/SAP Configuration/Validation Services Manufacturing Equipment Qualification and Process Validation

Quality Systems / CAPA / Corporate Systems
 		 Supplier Audits

Document Management Systems Configuration / Implementation / Validation Services Clinical Adverse Event Systems / Data Management and Safety
   


it&e
   IT&E International
   1610 Medical Drive, Suite 210
    Pottstown, PA 19464
    Tel number: (610) 340-2000     Fax: (610) 340-2007