InstantGMP: Manufacturing Execution System for GMP Manufacturing

Medical Device Manufacturing Execution System

InstantGMP™ QSR

Medical Device Manufacturing Software

Medical Device companies are required to produce products using Good Manufacturing Practices. InstantGMP™ QSR is a Cloud based Manufacturing Execution System for medical devices that makes manufacturing and regulatory compliance easy.

InstantGMP™ QSR provides a complete GMP manufacturing solution throughout your facility, across multiple functional divisions and across all sites. Standardized Manufacturing SOPs and policies that support the QSR system are available on our site so creating your completely documented quality system can be accomplished in weeks instead of months. Validation is done to meet the FDA's standards for producing medical devices. All other requirements for manufacturing medical devices are programmed into the application so GMP compliance is automated, taking the strain off of Quality Assurance personnel. The application effectively manages all of your electronic Device Master Records and Design History Files. These capabilities when combined in our application can make responding to a compliance letter or audit a routine process. Additional benefits are:

To summarize, InstantGMP™ QSR is a part 11 compliant Manufacturing Execution System with electronic batch records that streamlines the entire process of manufacturing medical devices made under Good Manufacturing Practices (GMP). It simplifies the documentation and approval procedures to reduce production times. The Device Master Records and the Device History Files are managed within the software to prevent errors, maximize quality and assure GMP compliance. All data can be viewed remotely from any location and has individualized security settings on every screen. The net result is better efficiency and higher quality than can be achieved with paper based systems.

Compliance with GAMP 5, 21 CFR Part 11 and Part 820 makes this manufacturing software ideal for producing finished medical device products.

Quality System Regulation (QSR) Medical Device Manufacturing Process

  1.  Introduction
  2.  QSR Process Flow
  3. Project Initiation Process
  4. Requisition Process
  5. Inventory Process
  6. Master Device Record Process
  7. Batch Manufacturing Process
These processes were used to validate InstantGMP™ QSR to FDA Standards for Medical Device Software Validation.  These sections contain templates you can use if you are planning to validate your own software.
Software Development Life Cycle             
Computer System Validation
Software Development Life Cycle Policy
Business Requirements Specification
User Requirements Specification
Functional Specification
Security Scheme
Detailed Design Specification
Unit Test/Factory Acceptance Test Scripts
Requirements Traceability Matrix
Source Code Documentation
Design and Coding Standards
Source Code Review
Risk Management
Software Release Form
  Computer System Validation Policy
Master Validation Plan
Installation Qualification
Operation Qualification
Validation Summary Report