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Compliance & Validation

​NNIT has a long & proven track record with qualification and validation projects in the pharmaceutical industry and has worked with GxP Computer System Validation since 1992.

NNIT is an active member of GAMP, ISPE, ECA and PhUSE, and participates in yearly conferences e.g. IVT's annual validation week, CSV & Data Integrity Compliance Congress, SmartLab Exchange, Lab of the Future Congress etc.

NNIT has delivered compliance & validation services for several pharmaceutical and biotech companies related to both laboratory informatics applications and computerized scientific instruments. NNIT has validated Laboratory Information Management Systems (LIMSs), Scientific Data Management Systems (SDMSs), Chromatography Data Systems (CDSs), as well as scientific instrument software for HPLCs, LC-MSs etc.

NNIT's Compliance & Validation offerings for laboratories are divided into:

  • Scientific instrument CSV

  • Laboratory informatics CSV & Automated testing


Scientific instrument CSV

Operating scientific instruments and equipment in laboratories in a GxP setting? NNIT can support you with Computer System Validation (CSV) to ensure data integrity and regulatory compliance. Visit our sub-site dedicated to scientific instrument compliance

Eliminating paper-based validation in laboratories by using Test Management for Life Sciences (TMLS)

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 and is built on Micro Focus ALM including 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. NNIT has used TMLS in laboratories to executive software validation of complex computerized instruments (e.g. LC-MS).

For further information on how to use TMLS in laboratories for software validation of complex scientific instruments, please visit our sub-site and listen to a recording of the webinar on "Digitalization of Compliance Processes in Laboratories".

For further information on how to speed up testing and improve quality using TMLS please visit our site about Intelligent QA

Laboratory informatics CSV & Automated testing

Are you implementing a new laboratory informatics application, or have you just upgraded the version of an existing application? Are you introducing new changes to you LIMS or ELN such as interfaces, reports or integrations and need help with the validation? NNIT can support you ensuring compliance and validation of your laboratory informatics applications.  NNIT has for the past 15+ years delivered compliance & validation services for several laboratory informatics applications (e.g. SDMS, CDS, LIMS).

For further information on our quality services related to compliance & validation please visit our sub-sites:


 

 

Nadia Sara Adjal +45 3077 8051nsra@nnit.comAdvanced Business Consultanthttps://www.linkedin.com/in/nadiaadjal/Nadia Sara Adjal

 

 

Scale Up 360° Pharma MES Europehttps://www.nnit.com/Pages/Scale-Up-360°-Pharma-MES-Europe.aspxScale Up 360° Pharma MES Europe
Pharma MES Asia 2020https://www.nnit.com/Pages/Pharma-MES-Asia-2020.aspxPharma MES Asia 2020
The Pharma Factory of the Future is Digital - and it needs MEShttps://www.nnit.com/Life-Sciences/Production-IT/Pages/The-pharma-factory-of-the-future-is-digital---and-it-needs-MES.aspxThe Pharma Factory of the Future is Digital - and it needs MES
Accelerated Implementation Methodologyhttps://www.nnit.com/Life-Sciences/Production-IT/Pages/Accelerated-Implementation-Methodology.aspxAccelerated Implementation Methodology
Webinar: Using Standardization and AI to Improve Data Quality in Life Scienceshttps://www.nnit.com/Life-Sciences/Intelligent-data-quality/Pages/Webinar-Standardization-and-AI.aspxWebinar: Using Standardization and AI to Improve Data Quality in Life Sciences
Whitepaper: MES Migrationhttps://www.nnit.com/Life-Sciences/Production-IT/Pages/Whitepaper-MES-Migration.aspxWhitepaper: MES Migration
Strategy & Guidancehttps://www.nnit.com/Life-Sciences/laboratory-informatics/Pages/Strategy--Guidance.aspxStrategy & Guidance
Laboratory System Transformationhttps://www.nnit.com/Life-Sciences/laboratory-informatics/Pages/Laboratory-System-Transformation.aspxLaboratory System Transformation
Requirement Specification & Vendor Selectionhttps://www.nnit.com/Life-Sciences/laboratory-informatics/Pages/-Requirement-Specification--Vendor-Selection.aspxRequirement Specification & Vendor Selection
Application Serviceshttps://www.nnit.com/Life-Sciences/laboratory-informatics/Pages/Application-Services.aspxApplication Services