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SmartQA

​Technology-driven Quality Management

The need to effectively accelerate  and manage quality has never been greater in the life sciences industry. To meet these expectations for speed and high-end quality, SmartQA offers technology driven Quality Management.

SmartQA addresses the need for Continuous Testing in DevOps, easy and fast ROI Test Automation, Digital Validation Lifecycle Management (VLMS), Paperless Validation and Continuous Validation for seamlessly and effective validation driven by technology.

Read article: Quality Management: Not just "a hazzle" but a tool for accelerating business.


A challenged field

SmartQA addresses a line of common challenges, including:

  • Resource constraints in quality management, testing or validation

  • No digitalization in quality management, testing or validation

  • Desire to speed up test or validation

  • Need for an alternative to offshoring test or validation

  • Need for cost effective test or validation

  • Lack of automation experience in-house

  • Limited tool knowledge for quality management

Key services

  •  

Technologies

  • ValGenesis

  • Leapwork

  • HP QC

NNIT capabilities

  • 10+ Automation SMEs

  • 25+ Automation Capable Resources

  • Compliance, Validation and Test Automation within LS domain

  • +240 man-years of experience in compliance and validation management

Benefits

  • Access to newest innovations and tools within technology driven quality management

  • Strong automation SMEs

  • Access to skilled resources within tool driven quality management

  • Market leading support on VLMS

  • Accelerated v-model

  • Continuous Testing as part of DevOps or as stand-alone

  • Continuous Validation through digital enhancements and tools

 

Test Management for Life Sciences (TMLS)

Speed up testing and improve quality

Test Management for Life Science (TMLS) is a market leading Test and Requirements Management Application supported and hosted by NNIT. 

TMLS is designed and validated by NNIT for use in life science companies. 

TMLS is built on Micro Focus ALM and includes an integrated 21 CFR Part 11 compliant eSignature functionality. 

TMLS has an optional integrated Automation – enabling more tests with less effort – saving time and ensuring constant high quality.


Challenges to beat

  • Manual paperbased testing

  • Overrun of testhours 

  • Lack of test control / compliance 

  • Budget overruns on quality activities 

  • Lack of realizing benefits of testing 

  • Lack of control and quality when test done from several locations/countries


TMLS - Key functionality 

  • Creation, review, and approval of specifications, test protocols, test cases, test reports and defects

  • Email notifications for approval tasks 

  • Asset Sharing: Enables users to manage approval of more than one e.g. test set at one time 

  • Requirements management 

  • Cross project reporting, planning and tracking

  • Reports: Fast and easy generation of inspection ready reports

  • Highly configureable approval work flow


Technologies

  • MicroFocus ALM

  • Tx3 e-signature 

  • Leapwork Automation


Accelerators

  • Customized template designed for customer processes 

  • Integrated Automation - Optional 


NNIT Capabilities 

  • 30+ Test experts

  • 10+ Automation experts


Benefits

  • Reduced time and cost of test planning and execution 

  • Automation option - do more with less effort - with constant high quality 

  • Access to skilled test experts

  • Access to market best practices on testing 

  • Access to newest innovations on testing

  • Flexible license management to fit business project demands

  • Dedicated Application Manager and support team 

 

 

Michael Clausen+45 3077 9120mccs@nnit.comAssociate Vice Presidenthttps://www.linkedin.com/in/michaelclausen1975/?originalSubdomain=dkMichael Clausen

 

 

Workshop: Hands-on experience on data integrity and validation of computer systemshttps://www.nnit.com/Pages/Hands-on-experience-on-data-integrity-and-validation-of-computer-systems.aspxWorkshop: Hands-on experience on data integrity and validation of computer systems
Cyber Defense Centerhttps://www.nnit.com/cybersecurity/Pages/Cyber Defense Center.aspxCyber Defense Center
Conference: Computer and IT Systems Validation Conferencehttps://www.nnit.com/Pages/IVT-20th-Computer-and-IT-Systems-Validation.aspxConference: Computer and IT Systems Validation Conference
Conference: Bio IT World 2019https://www.nnit.com/Pages/Conference-Bio-IT-World-2019.aspxConference: Bio IT World 2019
Validation Serviceshttps://www.nnit.com/Life-Sciences/quality-management/Pages/lean-validation.aspxValidation Services
Quality Management: Not just “a hazzle” but a tool for accelerating businesshttps://www.nnit.com/OfferingsAndArticles/Pages/quality-management-business-accelerator.aspxQuality Management: Not just “a hazzle” but a tool for accelerating business
Compliance Serviceshttps://www.nnit.com/Life-Sciences/quality-management/Pages/Compliance-as-a-Service.aspxCompliance Services
Test Serviceshttps://www.nnit.com/Life-Sciences/quality-management/Pages/NNIT-Test-Excellence-Center.aspxTest Services
Identity and Access Management Consultancyhttps://www.nnit.com/OfferingsAndArticles/Pages/-Identity-and-Access-Management-Consultancy.aspxIdentity and Access Management Consultancy
Identity & Access Managementhttps://www.nnit.com/cybersecurity/Pages/iam.aspxIdentity & Access Management