Customization & Integration
Services to Springboard Your Success
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 11, GAMP 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.
