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.
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|
|01||SDLC-POL-IGMP||Software Development Life Cycle Policy|
|02||SDLC-BRS-IGMP||Business Requirements Specification|
|03||SDLC-URS-IGMP||User Requirements Specification|
|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|