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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 NumberSoftware Development Document
01SDLC-POL-IGMPSoftware Development Life Cycle Policy
02SDLC-BRS-IGMPBusiness Requirements Specification
03SDLC-URS-IGMPUser Requirements Specification
04SDLC-FS-IGMPFunctional Specification
05SDLC-SS-IGMPSecurity Scheme
06SDLC-DDS-IGMPDetailed Design Specification
07SDLC-UTFAT-IGMPUnit Test/Factory Acceptance Test Scripts
08SDLC-RTM-IGMPRequirements Traceability Matrix
09SDLC-SCD-IGMPSource Code Documentation
10SDLC-DCS-IGMPDesign and Coding Standards
11SDLC-SCRF-IGMPSource Code Review Form
13SDLC-SRF-IGMPSoftware Release Form
Document NumberComputer System Validation
14CSVP-POL-IGMPComputer System Validation Policy
15CSVP-MVP-IGMPMaster Validation Plan
17CSVP-IQ-IGMPInstallation Qualification
18CSVP-OQ-IGMPOperation 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.

InstantGMPServices

Customization & Integration

Equipment Integration

Ensure all systems work together with available custom programming

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