Sarjen Systems Pvt. Ltd.  

Ahmedabad,  Gujarat 
India
http://www.sarjen.com
  • Booth: 320

Sarjen Systems is an ISO 9001-2015 certified Solution provider with experience of 19+ years in Pharmaceuticals and Life Science domains. Solution compliance with international standards like GMP, GLP, USFDA (21CFR Part11), EMA Annex 11 and other regulatory authorities worldwide. • Dossier Submission & Lifecycle Management • Pharmacovigilance Drug Safety Database • Enterprise Quality Management System • Manufacturing Execution System • Clinical Trial Management Suite


 Products

  • QEdge - eQMS
    QEdge helps to pharmaceutical and biotech industries to be more robust and well managed by bringing all the quality documents like market complaints, investigation, CAPA, deviation, risk assessment, change control and many more on single platform....

  • QEdge which is developed by Sarjen, is web based fully dynamic and electronic quality management system. With 18+ years of experience in development of software solutions and 10+ years in development of regulatory solutions, what Sarjen’s belief is all round CORE QUALITY & not just a visual delight!
    QEdge accommodates pharmaceutical and biotech industries in a dead set and disciplinary regulatory environment to make QMS more robust and well managed by bringing all the quality documents like market complaints, investigation, CAPA, deviation, risk assessment, change control and many more on single platform.
    QEdge has the functionality that after adaptation of the software by companies, it allows them to configure the software and use on current business policies and quality processes.

    For more inforation please visit http://qedge.sarjen.com

     

  • BizNet
    Clinical Trials Management<br />is a multi-functional platform which allows a CRO in planning, managing, designing, executing, monitoring and analysing trial related activities and data in adherence to the protocol and regulatory requirements....

  • BizNET-CTM is an end-to-end solution which caters to all the needs of clinical research project starting from Project Management, feasibility assessment, volunteer or patient enrollment, capture clinical trial data, multi-level review process, data compilation to data archiving.

    BizNET-CTM is a validated software, compliant with 21 CFR part 11 and GCP guidelines which provide a transparent and smooth process to regulatory bodies and sponsors.

    For more information please visit http://biznet.sarjen.com

  • PvEdge, Pharmacovigilance solutions
    It is an advanced Pharmacovigilance solution that helps combat the complexity of the safety data and comprehensively caters to all risk management requirements on a single platform, ensuring global regulatory compliance....

  • PvEdge, a safety reporting tool provides comprehensive analysis of adverse events arising from the use of pharmaceutical products (Drug, Medical Device or Therapy). It is an advanced Pharmacovigilance solution that helps combat the complexity of the safety data and comprehensively caters to all risk management requirements on a single platform, ensuring global regulatory compliance. The drug safety database allows the risk- benefit analysis of medicinal products taking into account new and emerging information, in the context of cumulative information.

    Phamacovigilance since beginning has been a compliance driven activity, wherein your regulatory compliance determines your company’s risk assessment scores. PvEdge, allows scheduling alerts for expedited cases, follow up cases and PADER/PSUR report submissions to meet regulatory timeline compliance.

    For more information visit http://pvedge.sarjen.com/