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.
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.
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?
With Health Canada's recent publication of its draft guidance entitled, "Information and Submission Requirements for Subsequent Entry Biologics (SEBs)," the agency has initiated its plan to introduce a comprehensive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.
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 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.