Software Development Life Cycle Policy – Manufacturing Software Validation

Looking at the life cycle policy for software development, the FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”  The the software development life cycle process ensures that[…]

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[…]

Message from an InstantGMP User

We love to hear success stories from our customers! Here is a message from an InstantGMP User who especially values the Quality initiatives the software provides: Hello! I hope all is well with you. I see that you continue moving forward with the electronic batch record system, InstantGMP. It is a great tool and I[…]

Innovative Formulations Achieves GMP Compliance and Success with InstantGMP MES

Innovative Formulations celebrates one year of business and one year of achieving GMP compliance with InstantGMP™ MES! Their team has quickly implemented a clearly defined and impressive blueprint for creating high quality nutraceuticals. “Beginning with the MPR Creation and Requisition process and ending with the final BPR approval – it’s easy to know exactly where[…]