If you consider the common problems of major software projects such as outright cancellation, schedule slips, and cost overruns it is clear that project managers and developers need better tools and better data than is common today.
What will probably be available within 10 years are these fully integrated capabilities that combine predictive analytics and full project measures and advanced development from certified reusable materials: Continue reading
Dr. Carolyn Turbyfill
TRADITIONAL COMPANIES, THE SOCIAL ERA AND PRIVACY
(A tribute toDr. Strangelove or: How I Learned to Stop Worrying and Love the Bomb)
Nilofer Merchant is an Internet champion for Social Era businesses in her blog: Continue reading
We see it all the time. From the little stickers on boxes or the huge signs touting the ‘new and improved version’ of something we already own. Household cleaning products are nearly infamous for it. Then again, they aren’t a permanent thing anyway and it won’t be too long until that container of ‘old and deficient’ product is gone and you can replace it with something better anyway. Continue reading
FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process.
Recent guidance and initiatives by FDA (Process Validation: General Principles and Practices) and ICH (Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES) have provided a streamlined risk based approach under an updated life cycle management methodology. Under this scenario, a new definition of validation has emerged, best described by FDA as;
“the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”
This is in contrast to the classical definition as perhaps best emphasized in the device regulations under 21 CFR 820.75:
“Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.” Continue reading
Plenty of companies got the idea that ISO 9001 certification was about proving conformity to requirements. We can tell by all of the QMS documentation designed to do just that. Sure, ISO 9001 certification certainly does involve demonstrating conformity to requirements. There are an infinite number of ways organizations could choose to define QMSs meeting ISO 9001 requirements.
ONE SHORT OF INFINITY
To define a QMS, there are infinity minus one ways, actually. The one way of demonstrating conformity to requirements that isn’t acceptable per ISO 9001: documenting the system according to the requirements of ISO 9001 (or, using a standard-based approach). Continue reading