Customization & Integration

Customization

InstantGMP™ can be customized to fit your specific needs. Our software experts will help you define your requirements and provide a customized solution that is built on the foundation of the existing software system and will work with our most recent software versions. Validation of the customized application is done to meet the FDA's standards for producing medical devices.

The Software Development Life Cycle steps and the Computer Validation steps that were used in developing Version 3.0 of InstantGMP™ MES, InstantGMP™ VAPE, and InstantGMP™ PRO assure compliance with 21 CRF Part 11, GAMP and GMPs. The documents generated in this process and their corresponding document numbers are shown in the two tables below.

Integration

InstantGMP™ can be used as stand-alone software or it can be integrated with other software systems, databases, and various equipment. Integration modules can be developed to work with your existing software to provide a system that eliminates redundant entries. A plan must be developed outlining specific design assignments for all involved parties.

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