Loftware partners with USDM Life Sciences
Enterprise labeling experts and regulatory consulting firm to deliver new solution for medical device companies.
Loftware, a global leader in enterprise labeling solutions, has announced that it has partnered with USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, to deliver the Loftware Validation Accelerator Pack (VAP).
The Loftware VAP enables medical device companies to implement and maintain a validated and compliant labeling solution. It complements Loftware Spectrum, a labeling solution designed to address the unique complexities and regulatory requirements of labeling in the pharmaceutical and medical device space.
The VAP provides a standardized approach for ongoing validation. Paired with Spectrum’s configurable workflow framework and eSignature capabilities, the solution is designed to facilitate 21 CFR Part 11. USDM’s VAPs have proven to help companies meet the requirements of the FDA and other regulatory agency validation requirements for computer systems and equipment supporting regulated functions.
“The UDI Final Rule certainly resulted in medical device companies updating or implementing new systems and equipment that require validation,” said Jay Crowley, vice president of UDI Services and solutions at USDM Life Sciences. “The Loftware Validation Accelerator Pack (VAP) helps these companies meet compliance requirements while reducing validation time and costs by up to 50%, achieving better efficiency and a competitive edge.”
Loftware and USDM will be showcasing the new Loftware VAP at the upcoming UDI Conference in Baltimore on April 18 – 19, 2016.
