Infor10 EAM

Infor10 EAM

EAM - Life Sciences

A single, comprehensive solution for streamlining compliance

Regulated industries — such as pharmaceuticals and biotechnology — face a specific set of challenges to meet compliancy requirements as set out by the regulating bodies. Those companies that don't comply face delays in time to market and can result in regulatory fines, plant closings and lost revenue.

Infor10 EAM for Life Sciences from Sapphire provides companies in these sectors with a complete, validated asset management solution — providing unparalleled security, stability and controlled configurability — that enhances EAM processes to meet regulatory requirements while improving efficiency and increasing the bottom line.

Infor's enterprise asset management solutions for life sciences helps you:
  • Track, maintain, manage and extend the life of critical assets
  • Comply with FDA 21 CFR part 11 regulations and ISO standards
  • Improve operational processes and productivity
  • Increase equipment and staff productivity
  • Infor10 EAM software is a complete, easy-to-use, web-based asset management solution for biotechnology and pharmaceutical companies to enable them to streamline their compliance and reduce costs. The following additional capabilities are included:

    Audit Trails — tracking and auditing tools to ensure FDA accountability

    Calibration Software — equipment, instrument, and process calibration, testing, and verification for ISO 9000, FDA, Joint Commission on Accreditation of Healthcare Organisations (JCAHO), and other regulatory standards

    Document Contro l — access and distribution rights management that protects sensitive documents to comply with protocols and procedures, including screening and approval for submissions, reviews, and approvals

    Electronic Signatures — advanced, signature controls that can be configured to operational needs to meet 21 CFR 11 requirements and enable an audit trail

    Preventive Maintenance Revision Control — built-in revision control to help ensure document integrity and protect and preserve documented maintenance procedures

    Record and Data Availability — ability to print and export records in multiple formats, including Adobe® Acrobat® PDF files and Microsoft® Excel spreadsheets, with a record library that documents alterations for FDA tracking

    Security — protection that exceeds 21 CFR 11 regulations for system access and authorised use to ensure required protection levels against record tampering and malicious attacks

    For more information, please call our Product Advisory Team at your local office .

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