GxP Lifeline October 2008 - Your Resource for Life Science Intelligence

October 2008

Video:

How Users are Reducing Risk with MasterControl

Feature Article:

Validating Electronic Spreadsheets or Automated Forms

For Pharmaceuticals:

America Leads the World in Cancer Research Investment

For Medical Device:

What's Wrong? Why Do We Have Repeat Investigations?

For Blood & Biologics:

Health Canada's Progress in Regulating Subsequent Entry Biologics

News for Life Science Professionals

FDA Crisis - An Attrition of Brain Power

Did You Know?

Did you know you can save time and resources during the medical device development process?


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Validating Electronic Spreadsheets or Forms

Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments of the medical device and pharmaceutical industries.


From simple record control through electronic signature approval routing and automated records processing, the validation of these functions can offer a substantial challenge to the average IT or QA personnel not familiar with computer systems validation activities. Specific to these challenges are the validation of electronic spreadsheets or forms.


For Pharmaceuticals: America Leads the World in Cancer Research Investment

A recent report from the Pharmaceutical Research and Manufacturers of America (PhRMA) says that U.S. pharmaceutical research and biotechnology companies are the primary source of R&D funding for new medicines. Industry-wide spending on research reached a record $58.8 billion in 2007.


For Medical Device: What's Wrong? Why Do We Have Repeat Investigations?

Repeat CAPA investigations are arguably one of the largest areas of concern for quality managers today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as 30% of all open investigations- or 1 in every 3. What's going wrong? Why is this happening to so many of us?


For Blood & Biologics: Health Canada's Progress in Regulating Subsequent Entry Biologics - Draft Guidance Issued in March

With Health Canada's recent publication of its draft guidance entitled, "Information and Submission Requirements for Subsequent Entry Biologics (SEBs)," the agency has initiated its plan to introduce a comprehensive regulatory, legal and scientific framework to approve biologic products that are similar to already approved biologics upon patent expiration.


News for Life Science Professionals: FDA Crisis - An Attrition of Brain Power

If people are an organization's greatest asset, the FDA's current "people status" is one of serious attrition. Reasons for attrition do not end at staffing pains however. The increased demand for science graduates also contributes toward attrition by creating a sellers market for new and experienced scientists. Many times, industry will intentionally court FDA scientists knowing that the high work load, lower pay and "politics" of the agency will work in their favor. Current FDA employees are also tempted to scope out new employment options and significant pay increase by considering industry opportunities.


Did You Know?

Did you know that developing your FDA or international regulatory strategy early in the medical device development process could save you time and resources?

Too often, medical device innovators develop their regulatory submission strategy near the end of the product development process, rather than at the start. They often make launch date commitments without considering important regulatory submission issues, such as product efficacy claims and testing to support those claims.
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