InstantGMP MES v2.052 Released

Cary, NC – InstantGMP, Inc. announces the release of InstantGMP MES v2.052 with amazing new features InstantGMP, Inc. added many great new functions and updates to their electronic batch records software to enhance their user’s experience. “We are excited about the new master production record and batch production record features in our v2.052 release” said[…]

InstantGMP MES v2.052.000

Let’s take a look at what’s new in the newest release, InstantGMP MES v2.052.000! New Functionalities Expanded badge signature capabilities to system-wide usage. Added new workflows focused on Project Management functionalities allowing for projects to include multiple products for multiple clients with multiple user access control under multiple roles. Added new Material Classifications to help employ[…]

Booming Natural Supplements Business in China

From Natural Products Insider, health food sales in China are estimated to reach RMB300 billion ($47.5 billion USD) by 2019. More and more Chinese consumers are looking to natural supplements as rates for certain illnesses such as lung cancer and breast cancer are on the rise, and they are looking to purchase foreign health products. It[…]

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[…]

FAQ Friday: E-signatures and 21 CFR Part 11 Compliance

In 2007, the FDA set forth rules governing e-signatures documentation known as 21 CFR Part 11. This is an important function in Good Manufacturing Practices. Here are a few frequently asked questions about how InstantGMP MES helps your comply with 21 CFR Part 11: Why do packagers, labelers and holding companies have to have Master[…]

21 CFR Part 11 Explained

With more and more manufacturing companies going paperless, the FDA created a set of rules regarding electronic signatures. The final set of guidelines known as 21 CFR Part 11 were put forth in May, 2007. Any individual using electronic systems in a FDA regulated manufacturing facility is required to follow the following procedures to be[…]

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[…]