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
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
There’s a mighty black and white, six minutes long documentary film enclosed to the italian progressive rock band PFM / Premiata Forneria Marconi Stati di Immaginazione (States of Imagination) music album. Its title is La Conquista (The Conquest), it shows how a savage Indios tribe succeeds in building, with very poor means, a bridge crossing a very dangerous river, to ensure its survival. Continue reading
You have heard it said dozens of times. We want a win-win situation with our subcontractors. I have an example of a win-win subcontractor experience that worked well and one example of one that did not turn out very good. Hopefully these examples will give you some insight into what is meant by win-win and now to make it happen. Continue reading