Industry experts speaking at an FDA public hearing voiced their support for the agency’s all-electronic submission system proposal, but warned that the agency has a lot to consider before going forward.
Any effective electronic signature solution should meet 21 CFR Part 11 and other regulatory compliance requirements, be easy to use and include graphical signature supports, said a new white paper from Arx.
Johnson & Johnson (J&J) and Cybertrust were the first organizations to be cross-certified with the SAFE Bridge Certificate Authority earlier this year, and SAFE-BioPharma Association President Mollie Shields-Uehling tells PIR two more “biggish” pharmaceutical players will join them by the end of this month.
Using esignature technology can help life science companies reduce the costs of conducting clinical trials and improve security while ensuring compliance with 21 CFR Part 11, but selecting the right type of system poses a challenge, according to an expert who hosted a recent webinar.
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 new survey from Frost & Sullivan.
The pharmaceutical industry’s new digital signature standard is eliciting praise from pharmaceutical IT experts and federal regulators, who are touting the standard’s potential for reducing paperwork, cutting costs and fostering interoperability among the drug industry’s many different players.
A coalition of eight pharmaceutical companies is gearing up a public relations campaign for the SAFE (Secure Access for Everyone) digital signature standard that will culminate in major announcements at the Drug Information Association’s annual meeting in June, a coalition spokesman said.
The Good Automated Manufacturing Practice (GAMP) Forum announced it will release a GAMP good practice guide Feb. 18 that will provide comprehensive direction on meeting current 21 CFR Part 11 expectations for compliant erecords and esignatures, including requirements for record integrity, security and availability throughout the required retention period.