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

5

Implement, Operate, Maintain

5

Val Packages for all Systems

5

Package of SLC, Policies, SOP’s

Clinical Data Management

5

EDC

5

CRO data Exchange

5

Enable Biometrics

5

Internal/External Data Collab

Clinical Operations

5

eTMF

5

CTMS

5

Software Updates & Changes

5

Vendor Assessment, IT Audits

Regulatory

5

Authoring, Review, Approval

5

Submissions

5

Registrations & Publications

5

Vendor Assessment, IT Audit

Safety

5

Safety Ops

5

Argus Support

5

Case Data Exchange

5

ARGUS Vendor Assessment

Quality

5

EDC

5

DMS, QMS Implementations

5

Software Update lifecycle

5

CAPA’s, Deviations, Audits

Inspection Readiness

5

System Overviews

5

System Risk Assessments

5

Relevant Val Packages

5

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.

Company

Celito Tech, Inc.

Mailing Address:

2100 Geng Road Suite #210

Palo Alto, CA 94303

Celito Tech, Inc.

Office Address:

842 Main St.

Redwood City, CA 94063

650.374.2121

Celito Tech India Private Limited

Flat No.A105, 1st Floor

Aditya's Imperial Heights,

Hyderabad, Rangareddi-500049

Telangana, India

+91 984.902.4174

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