Archives for May 2016

Need Help Implementing & Maintaining a Validated and Compliant Labeling Solution?

By Michael Ward, VP of Technical Services, Loftware | 05/06/2016 | 3:00 AM

Look no further - Loftware offers a comprehensive enterprise solution that meets the needs of medical device and pharmaceutical manufacturers. Loftware recently announced that they have partnered with USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, to deliver the new Loftware Validation Accelerator Pack (VAP). The Loftware VAP enables customers to quickly and cost-effectively implement and maintain a validated and compliant labeling solution. 

This new solution which simplifies compliance, increases productivity and minimizes validation costs, complements Loftware Spectrum, the industry’s most powerful labeling solution designed to address the unique complexities and regulatory requirements of labeling in the pharmaceutical and 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 and pharmaceutical labeling.

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,” stated 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.

“Our partnership with USDM is a perfect complement to Loftware Spectrum which provides unrivaled capabilities for meeting the complexities of labeling in highly regulated industries,” stated Josh Roffman, Vice President Product Management at Loftware. “With the Loftware VAP, we’re able to further accelerate and streamline the validation process, providing an integrated and comprehensive labeling solution that simplifies compliance, increases productivity and minimizes validation costs,” he added.

For more information on Loftware's new VAP or our Enterprise Labeling Solutions contact Loftware's team of labeling experts today.

The opinions expressed herein are those solely of the participants, and do not necessarily represent the views of Agile Business Media, LLC., its properties or its employees.

About Mike Ward

Mike Ward

Mike Ward, vice president of technical services, Loftware, is a 25-year veteran in software project management, sales engineering, technical support, and professional services. He is an expert in the labeling space, and leads pre-sales, professional services, and technical support teams that work with global companies to institute best practices for labeling, while enabling continuous, mission-critical operations.



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