GxP Systems Management
Strategic Consulting for IT GxP Management
For some teams, managing clinical data quickly becomes disjointed. Our consulting expertise and services can help. We implement a comprehensive program for managing IT GxP Applications and Data management meeting FDA regulatory requirements.
Integrate the processes, data, and technologies across Clinical, Quality, and Regulatory functions
Key Benefits
Rapid Deployment
Automated QA/QC Processes
Optimized Clinical Trials
Simplified Regulatory filings
Single versions of Content
Secure data and Access
Seamless 3rd Party integrations
Managed GXP Systems
Managed Validation Service
Inspection Readiness
Deploy expertise in the management of GxP Systems & Part 11 Compliance across key business domains
GxP Systems Management
Implement, Operate, Maintain
Val Packages for all Systems
Package of SLC, Policies, SOP’s
Clinical Data Management
EDC
CRO data Exchange
Enable Biometrics
Internal/External Data Collab
Clinical Operations
eTMF
CTMS
Software Updates & Changes
Vendor Assessment, IT Audits
Regulatory
Authoring, Review, Approval
Submissions
Registrations & Publications
Vendor Assessment, IT Audit
Safety
Safety Ops
Argus Support
Case Data Exchange
ARGUS Vendor Assessment
Quality
EDC
DMS, QMS Implementations
Software Update lifecycle
CAPA’s, Deviations, Audits
Inspection Readiness
System Overviews
System Risk Assessments
Relevant Val Packages
Backroom IT support
GxP Systems Management
Proper business process orchestration needs to follow the entire lifecycle of your product. Strategic consulting works to aid cross-functionality and collaboration for quality control.
Talent Deployed to Your Site
If your team lacks a designated IT GxP professionals, we can provide expertise in Validation, Vendor Assessments & IT Implementations.
Ready to learn more?
Celito is a team of experienced IT Executives, Industry Professionals, and Business Consultants focused on the life sciences industry.
Products
Consulting
Company
Celito Tech, Inc.
CORPORATE HEADQUARTERS
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Palo Alto, CA 94303
US OFFICE LOCATION
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Redwood City, CA 94063
+1 650.374.2121
Celito Tech, Inc.
INDIA OFFICE LOCATION
Celito Tech India Pvt Ltd.
Flat No.A105, 1st Floor
Aditya's Imperial Heights,
Hyderabad, Rangareddi-500049
Telangana, India
+91 984.902.4174
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