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Comparing Pharmaceutical Continuous Monitoring Systems: Part 1
Looking at compliance, risk, and cost for stand-alone, wired, and wireless systems
Food Safety: Challenge or Opportunity?
How regulations are viewed prevents or enables them to promote business goals
When All Else Fails, Lower Your Standards
This seems to be the thinking for two pharmaceutical manufacturers
Savvy Compliance Strategy, Part IV
Closing the circle of compliance loop
21 CFR Part 11: Auditors Are at Your Door
FDA steps up inspections to detect fraud and data manipulation
One-Year Exemption from FDA Inspections Possible
Some medical device manufacturers qualify under ISO 13485
Congress Can Wait… But the FDA Won’t
The FDA’s new enforcement culture won’t compromise public safety
Savvy Compliance Strategy Can Improve GMP
The Circle of Compliance prevents the merry-go-round of audits and fixes.
Achieving the LIMS Promise
What application convergence means to the future of laboratory automation

On My Honor
Is the concept of honor simply too difficult to understand?

FDA Inspectional Observations Increase Focus on Qualifications, Personnel Training
Appropriate training will bring considerable business value to your organization.
Defining Quality: The FDA’s Position on Good Manufacturing Practices
More Stringent FDA Review Processes for Medical Devices on the Horizon
The FDA prepares to review and revise the 510(k) process.
Precise Pipetting Helps Set Standards for Molecular Diagnostics
MMQCI uses ARTEL PCS to strengthen liquid handling quality assurance
On-Demand Compliance Software Helps Small Medical Device Makers Compete
Subscription-based quality management and compliance software levels the playing field.
Electronic Medical Device Reporting Best Practices
Steps for a smooth transition from paper-based reporting
Good night and sweet dreams!
Accurate scanning of CAD files and injection molded prototype parts help launch new anti-snoring device.

New Protocols Will Test Effects of RFID Systems on Medical Devices
Georgia Tech Research Institute recently began developing testing protocols for RFID technology in the health care setting.
New Food Safety Policy Adds to Confusion
HR2749 and NAIS explained
ISO 13485: Creating a Globally Harmonized Quality System
An overview of the standard's requirements and use around the world.

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