InstantGMP: Manufacturing Execution System for GMP Manufacturing

Medical Device Manufacturing Software Validation

Medical Device ManufacturingSmall enterprises that manufacture medical devices are held to the same rigorous Quality System Requirement (QSR) standards as large, multinational corporations. Often small manufacturers cannot afford the commitment and budget needed to meet these requirements while large manufactures will invest hundreds of thousands, in some cases millions of dollars to install a customized manufacturing software solution that manages their entire production process. The only option open to small manufacturers was to struggle with low cost, off-the-shelf manufacturing execution systems or inventory control systems that were not designed or validated to medical device software standards. Now InstantGMP™ QSR provides a viable solution to that dilemma.

InstantGMP™ QSR is a new medical device manufacturing software designed especially for small enterprises. While there are many good Enterprise Resource Planning (ERP) software systems available, only InstantGMP™ QSR has the workflows and processes required by the FDA’s Quality System Regulation (QSR) built into the software. This makes the software easy to use, makes it easy to stay in compliance and makes this an affordable alternative to larger, more expensive ERP systems. 

Why is it important to you that InstantGMP™ QSR is validated to FDA standards? The FDA's validation requirements apply to software used in production of medical devices or in implementation of the device manufacturer's quality system. That is why InstantGMP™ QSR is validated to these standards. Because InstantGMP™ QSR is a cloud application and comes to you fully validated, you do not need to do any additional validation before implementing the software in your operation. Please follow the links below to learn more about how InstantGMP, Inc. can be your complete compliance solution provider.

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