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Micronova ICS ERP Validation (Enterprise Resource Planning) and Infrastructure Qualification
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.
Supplier: Micronova ICS MICSERPVCES
Description
- 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
| Controlled Environments Services | |
| FDA 21 CFR |
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