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SOFTWARE FOR YOUR SITUATION:

CUSTOMIZATION & INTEGRATION

Customization

If there is something specific that you need, not found in the standard InstantGMP software design, we can customize it to fit your specific demands. Our software experts can help you define your requirements and provide a customized solution.

Validation of the customized application is done to meet the GAMP 5 and FDA’s validation standards.

The Software Development Life Cycle steps and the Computer Validation steps that were used in developing Version 3.0 of InstantGMP™ PRO assure compliance with 21 CRF Part 11GAMP 5 and GMPs.

Document Number Software Development Document
01 SDLC-POL-IGMP Software Development Life Cycle Policy
02 SDLC-BRS-IGMP Business Requirements Specification
03 SDLC-URS-IGMP User Requirements Specification
04 SDLC-FS-IGMP Functional Specification
05 SDLC-SS-IGMP Security Scheme
06 SDLC-DDS-IGMP Detailed Design Specification
07 SDLC-UTFAT-IGMP Unit Test/Factory Acceptance Test Scripts
08 SDLC-RTM-IGMP Requirements Traceability Matrix
09 SDLC-SCD-IGMP Source Code Documentation
10 SDLC-DCS-IGMP Design and Coding Standards
11 SDLC-SCRF-IGMP Source Code Review Form
13 SDLC-SRF-IGMP Software Release Form
Document Number Computer System Validation
14 CSVP-POL-IGMP Computer System Validation Policy
15 CSVP-MVP-IGMP Master Validation Plan
17 CSVP-IQ-IGMP Installation Qualification
18 CSVP-OQ-IGMP Operation Qualification

Integration

While InstantGMP is an effective stand-alone software, it can also be integrated with other software systems, databases, and various equipment. If this is something you would like to explore, let us know. We will work with you to define requirements and develop a plan outlining specific design assignments for all involved parties, so integration modules could be developed to work with your existing software, ensuring a system that eliminates redundant entries.

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