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Validation Accelerator Pack for Medical Device Companies



Loftware, Inc., a provider of enterprise labeling solutions, has partnered with USDM Life Sciences, a global regulatory consulting firm in the life sciences industry, to deliver the Loftware Validation Accelerator Pack (VAP). The Loftware VAP is designed to enable medical device companies to quickly and cost-effectively 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 medical device space.

The Loftware VAP, which enables Loftware's medical device customers to validate Loftware Spectrum to meet FDA and EU regulatory requirements, provides a standardized approach for ongoing validation. "The Loftware VAP, paired with Loftware Spectrum's configurable workflow framework and eSignature capabilities, provides a jump-start towards validation and helps to facilitate 21 CFR Part 11, underscoring Loftware's ongoing commitment to medical device labeling," said a company spokesperson. "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 developed the Loftware VAP to be comprehensive and include key components for validation and compliance in the medical device field:

  • Validation Plan
  • System Requirement Specifications
  • Functional Risk Assessment
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Traceability Matrix
  • Validation Summary Report
  • Vendor Audit Report
  • 21 CFR 11 Assessment.

The package is a complete set of content rich validation templates that are ready to be configured to reflect each customer's configuration decisions.

For more information contact:

Loftware, Inc.

249 Corporate Drive

Portsmouth, NH 03801

603-766-3630

www.loftware.com

USDM Life Sciences

535 Chapala St.

Santa Barbara, CA 93101

888-231-0816

www.usdm.com

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