Simplifying Global Compliance
Articles Tagged with ''Part 11''
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. Read More
Generic drugmaker Apotex has lost its bid to market a 40-mg version of AstraZeneca’s $1.7 billion heartburn drug Prilosec, after a federal court ruled against Apotex in its lawsuit against the FDA. Read More
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. Read More
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. Read More
Orthovita, a biomaterials company specializing in the development of products that help restore fractured bones, just selected Master-
Control's integrated quality management suite to facilitate compliance with 21 CFR Part 11 and other FDA requirements. Read More
Canadian drug firm Biolyse Pharma has started mining Canadian evergreens for the main ingredient in antiviral Tamiflu — shikimic acid — and said it is poised to supply the ingredient to drugmakers and governments in countries where Tamiflu isn’t patented. Read More
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efforts to advance electronic dissemination of data, according to recent industry comments posted to the agency’s “Draft Guidance for Industry on Using Electronic Means to Distribute Certain Product Information.” Read More
A well-crafted risk assessment and management program can strengthen a firm’s compliance efforts by providing clarity, easing the regulatory workload and generally making the operation run more smoothly, experts said last week at an industry conference. Read More
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. Read More
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. Read More
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