Data Integrity and Validation: An Interview with Cerulean CEO John Avellanet
We may not be hearing much about 21 CFR Part 11 lately, but that doesn’t mean it is going away.

Therapeutic Dose: 'Til Death do us Part... But First, Here's the Pre-Nuptial Agreement
The CAPA is still necessary, but it needs to morph into something new under the QbD and PAT manufacturing examples.

Choose Wisely
Selecting a contract manufacturing organization (CMO) for aseptic processing of injectable final drug product (FDP) is no simple matter. Here are some do’s and don’ts.

Technology Roundup: Reducing Operator Error at Its Source
Companies are reducing operator error as techniques such as Jidoka begin to penetrate drug manufacturing facilities.

From the Editor: Can Your Data Stand Up in Court?
Rumors of 21 CFR Part 11’s demise have been greatlly exaggerated. Data integrity is at the heart of numerous 483s and a recent lawsuit against Novartis.

Cause for Alarm?
Alarm systems are often the first indication of whether underlying processes are understood and in control. Nuisance alarms must be eliminated and alarms categorized and prioritized so that their connection to product quality is clearly understood.

Inching Toward Jidoka
Often called 'automation with a human face', Jidoka is a pillar of the Toyota Production System. Pharma has yet to embrace the concept, although results of our 2007 survey on process control suggest that more facilities may be getting closer.

OpEd: Offshoring and Immigrants in the Workforce
Immigrant education in math and science is discussed as necessary to U.S. Pharma, while readers respond to June's cover story on offshoring.

Achieving Clean Pharmaceutical Water
Controlling microbiological contamination is an ongoing process laden with risks. The best weapon against biofilm is prevention.

A Development Roadmap for Combination Products
Comparing progress against a set of criteria such as Design for Lean Six Sigma ensures that the somewhat synchronous development philosophies of devices and drugs are being considered appropriately.