January 26, 2016

Customization & Integration

Customization

InstantGMP™ MD & PRO 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, InstantGMP™ MD 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™ MD & PRO can be used as stand-alone software or it can be integrated with other software systems or databases. 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
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