by vendor

  Loftware Spectrum® Validation Accelerator Pack for Enterprise Labeling Now you can streamline the validation workload for a standardized Enterprise Labeling Solution while meeting evolving FDA and EU regulatory requirements. USDM Life Sciences and Loftware have partnered to develop a Validation Accelerator Pack (VAP) to simplify compliance, increase productivity and minimize costs. The Loftware Spectrum VAP—leveraging the industry’s most powerful labeling solution—enables medical device companies to quickly and cost-effectively implement and maintain a validated, compliant labeling solution. In many cases, companies have reduced validation time and costs up to 50%. Validation Plan System Requirement Specifications Functional Risk Assessment Installation Qualification Operational Qualification Performance Qualification Traceability Matrix Validation Summary Report 21 CFR 11 Assessment The VAP templates are in MS Word and can be easily updated to include your specific information and project details. For more information, contact Loftware at SalesInfo@loftware.com.  
The USDM Life Sciences VAP for Remarque contains validation plans, system requirements, IQ/OQ/PQ test scripts, a traceability matrix, and a vendor audit report. The Cloud Assurance offering provides updates to this VAP content with each software release, and can be executed by USDM to save time and testing costs.With USDM and Remarque’s RBM solution, Life Science customers can now use Remarque to manage RBM by: Reducing implementation time and cost to achieve RBM readiness Scale RBM capabilities to meet regulatory mandate and customer demand Reduce costs Pilot-based approach that can scale as needed with no infrastructure change requirements Fast-track RBM strategy by implementing industry-leading RBM technology aligned to your process USDM Life Sciences and Remarque are changing the way Life Sciences organizations do business by allowing quick and efficient implementation of Risk-Based monitoring.
USDM Life Sciences’ Validation Accelerator Packs (VAPs) for PLM platforms, including PTC Windchill, are a complete set of validation document templates that enable customers to significantly reduce validation time and cost, as well as reduce implementation time and improve system performance. PTC’s Medical Device Industry VRD supports USDM’s Validation Accelerator Pack for PTC Windchill to assist customers in validating the PTC solution’s compliance with FDA regulations for the design and development of safe and effective medical devices.
Generis and USDM Life Sciences have partnered to provide a solution for Documentum clients looking to upgrade, move to a new platform, or replace FirstDocs with CARA. Generis has been providing software for content management since 2002, when the first version of CARA was released. CARA is the most advanced, fastest and most feature-rich user interface for Documentum, Alfresco and Oracle WebCenter. CARA is supported by other modules such as DocSecure for watermarking and eSignature. The USDM Life Sciences Generis VAP provides the components and services required to rapidly and cost-effectively meet FDA regulatory requirements: Stay compliant with the latest releases of Documentum by using CARA to replace Webtop Replace existing FirstDoc configurations with CARA configurations Keep your existing business rules but converted into CARA business rules Save on your combined FirstDoc + Webtop maintenance costs with the lower cost of CARA maintenance Avoid the large costs of FirstDoc version…
  Clinical trial professionals are often frustrated with the inefficiencies surrounding clinical study software that does not work with their office software. TranSenda's Office-Smart clinical trial software solutions address the need to unify study software with the familiar, widely supported and easy-to-use Microsoft Office System. Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of BioClinica Clinical Trial Management System validation professionals can provide your organization with innovative and streamlined alternatives to industry standards. USDM Life Sciences has been successful across many BioClinica Clinical Trial Management System validation projects around the globe and our best-in-class validation services coupled with proven and effective methodologies can give your organization the competitive advantage it needs to thrive in today's regulated environment.  
DocuSign and USDM Life Sciences have partnered to enable life sciences companies to streamline regulated business processes and execute signatures using DocuSign’s Digital Transaction Management solution. USDM has expanded its VAP and Cloud Assurance offering to include a Validation Accelerator Pack (VAP) and compliance offering for DocuSign that enables DocuSign customers to meet 21 CFR Part 11 and can be easily implemented and validated. The USDM Life Sciences DocuSign VAP provides the components and services required to rapidly and cost-effectively meet FDA regulatory requirements associated with the validation of DocuSign: DocuSign Validation Plan template defining the validation strategy and deliverables Functional Requirement Specification (FRS) template tailored to life sciences application requirements Risk Assessment template to address the basis for testing against the FRS requirements Trace Matrix template to track the satisfaction of these requirements in the USDM Life Sciences DocuSign test protocols Installation Qualification protocol template to document and verify…
The USDM Life Sciences Alfresco VAP provides the components and services required to rapidly and cost-effectively meet FDA regulatory requirements associated with the validation of Alfresco / CARA: Alfresco Validation Plan template defining the validation strategy and deliverables Functional Requirement Specification (FRS) template tailored to life sciences application requirements Risk Assessment template to address the basis for testing against the FRS requirements Trace Matrix template to track the satisfaction of these requirements in the USDM Life Sciences Alfresco test protocols Installation Qualification protocol template to document and verify your installed configuration of the application Operational Qualification protocol template to document and verify the functionality of Alfresco Performance Qualification protocol template to verify end-to-end business processes across Alfresco modules, representing the field service product lifecycle Validation Final Report template to summarize the results of the validation effort Standard Operating Procedure templates ready to tailor to your operations Optional subscription to updated…
USDM Life Sciences has Validation Accelerators Packs that provide a turn-key solution to get HP’s Quality Center and Performance Center validated and ready for use in no time. Once validated, USDM Life Sciences has partnered with Genilogix to provide a Testing Accelerator for ERP. The Testing Accelerator for ERP provides an accelerated solution for automated functional and regression testing to ERP customers. Entirely based on the HP Quality Center and HP Business Process Testing platforms, the Testing Center for ERP provides customers with a pre-built automated testing framework, defect tracking workflow and best practices for requirements management. The Testing Accelerator for ERP can help: Dramatically reduce time and costs associated with testing ERP Support multilingual ERP deployments with one testing framework Test ERP more thoroughly and more frequently Reduce or eliminate (with TestAssure) the effort to maintain test scripts to keep up with changes to transactions Establish best-practices guidelines, complete with…
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  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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