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Micronova ICS ERP Validation (Enterprise Resource Planning) and Infrastructure Qualification
SDP

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To learn more about how to bring this service to your organization, please select Request a Quote to reach our dedicated service support team.

Description

Micronova ICS offers ERP software support and validation, end-to-end GxP, validation, and quality support for companies with corporate IT programs. Infrastructure qualification (on-premises or Cloud hosting) support is also provided.

  • IT integration and carve-out projects
  • Vendor selection
  • User Requirement Specification (URS) workshops - requirement collection
  • Functional and design specification review
  • Risk assessment and mitigation
  • Test execution
  • Data integrity and security assessment
  • Documentation and reporting
  • Final review and approval
  • Training and support
  • Compliance with regulations like FDA 21 CFR Part 11, EU GMP Annex 11
  • Implementation and upgrades of corporate applications (ERP solutions (SAP) and QMS software)
  • Using customer QMS software (TrackWise, MasterControl, ALM)
  • Following SDLC framework for all validation deliverables

Order Info

Please be advised that some services may have a fee associated with them. Request a Quote for more information and to discuss your specific requirements with our services experts.

Compliance

CFR Title 21, Parts 11/ EU GMP Annex 11

Specifications

Product Type Controlled Environments Services
Federal Regulation FDA 21 CFR
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