Articles Tagged with ''Part 11''

BloodSource Taps MasterControl Software for Part 11 Compliance

BloodSource, a regional nonprofit community blood center serving 39 hospitals in 25 counties in northern and central California, has chosen the MasterControl quality management suite to facilitate FDA compliance, foster efficiency, and increase effectiveness, MasterControl announced last month.

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Software Validation Remains Important FDA Focus

Though it has shifted hard away from active Part 11 enforcement or even much public discussion of the rule by name, the FDA remains committed to seeing that regulated firms can demonstrate that their computer software does what it is supposed to do, experts tell PIR.

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Part 11 Requirements Remain Main Driver of IT Spending

Life sciences industry spending on IT is rising rapidly and poised to accelerate more than 15 percent each year through 2011, in part due to Part 11 compliance and legacy system remediation projects, says a survey from Frost & Sullivan.

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Firms Applaud Guidance; Express Concerns About Part 11

Pharmaceutical firms have generally lauded the FDA’s efforts to advance electronic dissemination of data, according to recent industry comments posted to the agency’s “Draft Guidance for Industry on Using Electronic Means to Distribute Certain Product Information.”

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Part 11 Requirements Still Important, Industry Experts Warn

The FDA has not lost interest in electronic data integrity, audit trails or computer system validation, even though it has stated it will exercise enforcement discretion regarding 21 CFR Part 11, experts stressed at FDAnews’ recent FDA Information Management Summit in Bethesda, Md.

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Part 11 Requirements Still Important, Experts Warn

The FDA has not lost interest in electronic data integrity, audit trails or computer system validation, even though it has stated it will exercise enforcement discretion regarding 21 CFR Part 11, experts stressed at FDAnews' recent FDA Information Management Summit in Bethesda, Md.

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