Quality System Requirement – Manufacturing Software Validation

Small enterprises that manufacture medical devices are held to the same Quality System Requirement (QSR) standards that apply to all medical devices, but often small manufacturers cannot afford the commitment and budget needed to become more efficient. Large manufactures will invest hundreds of thousands to 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 buy 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™ MD provides a viable option to that dilemma.

InstantGMP™ MD 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™ MD, our quality system requirement based software,  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.

The FDA’s validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer’s quality system. That is why InstantGMP™ MD is validated to these standards. Because InstantGMP™ MD is a cloud application and comes to you fully validated, you do not need to do any additional validation before starting to use in your operation.

Click here to see all of the validation processes used for a medical device manufacturing software system.

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