Unvail OC11 SaaS CGMP Platform

ADPT Solution (ADPT LLC) is set to UNVEIL the OC11 SaaS CGMP Single Computer System Validation Platform:
 
EVENT: CPHI Milan, Italy
DATES: From 8 to 10 October 2024
LOCATION: ADPT Solution Booth 6SU83 - Hall 6 near the Product Gallery

This innovative, proven SaaS cloud solution sustains CGMP and Data Integrity (DI) regulatory compliance and minimizes time, effort, and expense. It is cost-effective, simple, compliant, and proven to ensure business owner executives make intelligent financial decisions for your organization.

OC11 SaaS CGMP Platform Innovations Inspected by regulatory agencies

·       Single Computer System (CSV) Validation

·       Training Artificial Intelligence (AI)

·       Real-Time Forced Audit Trail Review

·       World Languages
 

·       Single Computer System (CSV) Validation:

Any system developed on the OC11 Validated Platform DOES NOT REQUIRE ANY ADDITIONAL CSV that includes eQMS – Quality Management System (Change Control, Deviation, Investigation, CAPA, OOS, etc.), eDMS – Electronic Document Management System (SOPs, Specifications, Any MS Word Forms, Lab notebooks etc.), Training AI, Calibration, Maintenance, eLogbooks, Sample Management, and eMBRs – electronic Master Batch Record.

 

·       Training Artificial Intelligence (AI):

The OC11 Training AI autonomously manages employee access levels according to their curriculum and completed training before accessing them.

 

·       Real-Time Forced Audit Trail Review of CGMP Critical Data:

The reviewer and approver must review any critical CGMP data audit trail alterations before applying an electronic signature.

 

·       SOPs Review Cycle Management Automation:

The OC11 Platform autonomously manages the configured review cycles and eliminates human interventions and manual errors.

 

·       OC11 Support System:

The OC11 Support system allows all end-users to generate tickets online. The ADPT Solution technical team evaluates all tickets and resolves them promptly 24/7.

 

·       World Languages:

Systems can be developed in many languages with relative ease.

 

·       Built-in interfaces and Change Control

The built-in interfaces and change control streamline connectivity with all systems and change controls to change systems efficiently.

 

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