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Computer software Products (28)

  • Product 21 CRF Part 11 & EU GMP annex 7

    ManageArtworks has built-in features to help your organization enhance your compliance:

    • Access Control with Password PoliciesUser and Role based Security Settings • Audit Trails with Timestamps • Electronic Signatures with Authentication and Logging • SSL based communication
  • Product PSMF-Manager

    The Gruppo SASI’s solution, called PSMF Manager, for the management of the Pharmacovigilance System Master File, is developed in full compliance with the legislation in force for the European community published on the European Medicines Agency website (www.ema.europa.eu) whose legal requirement was intr...
  • Product Aria Smart Auto-injector

    Phillips-Medisize developed the Aria smart autoinjector platform — a convenient, handheld system that consists of a reusable electro-mechanical injector and a pre-filled, disposable syringe. This ground-breaking device integrates Bluetooth connectivity to improve the patient experience while allowing healthca...
  • Product SafetyDrugs

    SafetyDrugs is a safety database 
  • Product CONSULTANCY - COMPUTER SYSTEM VALIDATION / TRAININGS / REGULATORY AFFAIRS

    PROJECT MANAGEMENT  WITH CS VALIDATION WITH COMPLETE DOCUMENTATION(GAMP 5, CFR 21 PART 11, ANNEX 11 ETC) SAP OR ANY ERP SOFTWARE• QUALITY MANAGEMENT SYSTEM SOFTWARE• DOCUMENT MANAGEMENT SYSTEM SOFTWARE• STABILITY MANAGEMENT SOFTWARE• ARTWORK MANAGEMENT SOFTWARE• LABORATORY INFORMATION MANAGEMENTSYST...
  • Product MasterControl Product Life Cycle Management Platform

    Quality is the essential ingredient in any product. It can mean the difference between getting an innovation to market – or putting the whole project on hold. Quality is the key differentiator that builds trust with customers and keeps them coming back for more. But maintaining consistent quality throughout y...
  • Product TechFile-Manager

    IntroductionGruppo SASI's offer for the management of the Technical File for Medical Devices is developed in full compliance with the legislation in force for the European community as illustrated in the REGULATION (EU) 2017/745 and 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017&n...
  • Product eCTD-Pharma

    eCTD-PHARMA is a modern and innovative software for the design, implementation and electronic submission of Dossier of Medicinal Products, according to the organisational models defined by the CTD/eCTD Standard, and for the subsequent management of its Life Cycle. With equivalent completeness and ef...
  • Product MasterControl Manufacturing Excellence

    MasterControl delivers the next level of manufacturing excellence by bridging the gap between performance and quality with digital production records that finally let you go 100% paperless.
  • Product MasterControl Quality Excellence

    Commercialization strategies evolve, supply chains expand and production rates accelerate. Things change. You adapt. But the only way to take control of your future is to double down on quality. It's the ultimate game changer. That's why you need MasterControl; the platform for quality.

  • Product Packaging ‘parts’ and ‘components’

    • Pharma products come in numerous SKUs.Different doses for the same brand are considered different products, and different sizes for the same product are considered different packages.  • Each different product or package requires different text for labels, boxes, and shippers. Besides the labels, a p...
  • Product SLIMStat - Shelf-Life Projection Software

    SLIMStat is extremely easy-to-use software developed and validated specifically to determine the shelf life of drug products that have been placed on stability. This interactive and intuitive tool empowers non-statisticians the ability to generate statistical analyses with complete confidence. Fully vali...
  • Product eCTD CTD - KnowledgeNET

    Dossier life cycle management and publishing solution which create, compile, manage & publish your IND, NDA, ANDA, DMF, ASMF and CEP submissions effortlessly,
    Knowledgenet is a complete eCTD dossier publishing & submission solution and is fully compliant with ectd module 1 specifications EU v3....
  • Product eBMR. BCR, MES, ProcessXE

    Process XE, smart manufacturing automattion solution; helps digitise entire manufacturing process, easily integrable with enterprise business systems improving operational visibility and compliance
    across production value chain.
    Suite of solutions for Process automation:

    > Electr...
  • Product CTM, Clinical Research, BA/BE Studies, BizNET

    BizNET-CTM, an end-to-end platform for clinical trials; right from Early phase, Late phase, Oncology to Registry to Post approval trials.

    Suite of solutions for Clinical Research:


    > eCRF, EDC and Clinical Data Management
    > IWRS and Pharmacy Management
    > Medical Ima...
  • Product eBMR. BCR, MES, ProcessXE

    Process XE, smart manufacturing automattion solution; helps digitise entire manufacturing process, easily integrable with enterprise business systems improving operational visibility and compliance
    across production value chain.
    Suite of solutions for Process automation:

    > El...
  • Product eCTD CTD - KnowledgeNET

    Dossier life cycle management and publishing solution which create, compile, manage & publish your IND, NDA, ANDA, DMF, ASMF and CEP submissions effortlessly,
    Knowledgenet is a complete eCTD dossier publishing & submission solution and is fully compliant with ectd module 1 specifications EU v3.0....
  • Product Update Yourself with Latest version of L4-L5 Solutions and Russia Regulation - Presentations at PMEC Booth

    Please click below Link to Register Now

    Link :- https://forms.gle/N3jwpeShVq9GB4Xy9
  • Product CTM, Clinical Research, BA/BE Studies, BizNET

    BizNET-CTM, an end-to-end platform for clinical trials; right from Early phase, Late phase, Oncology to Registry to Post approval trials.

    Suite of solutions for Clinical Research:

    > eCRF, EDC and Clinical Data Management
    > IWRS and Pharmacy Management
    > Medic...
  • Product pharmamarket.info

    Platform for medicines wholesale supply and availability information.  http://pharmamarket.info

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