Most Common GMP Citation for Supplement Producers: Not Establishing Specs

A few weeks ago, the Rocky Mountain Dietary Supplement Forum saw who’s who of the dietary supplement industry converge in Boulder, Colorado. According to this article by Josh Long of Natural Products Insider, numerous FDA officials gave presentations regarding their experiences and noted that failing to establish specs is the most common GMP citation in[…]

Language of InstantGMP Software

Let’s take a look at the language of the InstantGMP software. You see them on our website, in our training materials and in the software itself – the manufacturing world uses a lot of abbreviations! We’ve defined a few of them for you here:   21 CFR Part 11 FDA regulations covering security electronic signatures[…]

Manufacturing Software Validation – Design and Coding Standards

While every computer programming language has specific rules and syntax, there are usually several valid ways to achieve the same result, especially with manufacturing software. Differences in programming styles can have a substantial negative impact on a project during the development phase, and especially when the program needs maintenance and changes. Sometimes programmers cannot easily[…]

User Requirements Specification – Manufacturing Software Validation

A User Requirements Specification (URS) document may be created for all new or replacement computerized systems as defined in the Software Development Life Cycle document and may also provide the basis for the system design and Process Flow Diagrams. The purpose of the URS is to define the company’s interpretation of the projected users’ solution[…]

Manufacturing Software Validation – Requirements Traceability Matrix

The Traceability Matrix defines the relationship between the Requirements / Specification Documents, Design Documentation and Test Scripts as defined in the Testing Protocols for the InstantGMP™ MD medical device manufacturing software. The Traceability Matrix provides a method to trace and ensure that system validation addresses all requirements, specifications and functions addressed during the test phase of[…]

Risk Management – Manufacturing Software Validation

Quality risk management is a systematic process for the assessment, control, communication, and review of risks. It is an iterative process used throughout the entire computerized system life cycle from concept to retirement. Risk Management is based on clear process understanding and potential impact on patient safety, product quality, and data integrity. Controls are measures[…]

Detailed Design Specification – Manufacturing Software Validation

The Detailed Design Specification (DDS) describes how the hardware and software functionality identified in the Functional Specification will be developed and implemented. The Hardware DDS is a description of the hardware on which the software resides and how it is to be connected to any existing system or equipment. Where possible, hardware used should be[…]