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    Pharmaceuticals & Biotechnology

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    Home » Pharmaceuticals & Biotechnology

    The Challenge

    Pharmaceutical and biotechnology industries are under constant pressure to meet rigorous regulatory requirements imposed by regulatory agencies such as the FDA and EU. Globalization, increasing complexity of diseases, introduction of new technologies, and new demands from the market, make the regulatory environment to change continuously.

    SoftExpert offers the most complete software for the pharmaceutical industry, fulfilling every aspect of this sector’s specific needs, from product lifecycle management to monitoring of performance indicators and process optimization, simplifying compliance and quality management.

    Pharmaceuticals & Biotechnology Solution

    SoftExpert Excellence Suite lowers the cost of regulatory compliance and helps companies maximize success, increase productivity, reduce risk and adhere to various regulations.

    The solution enables pharmaceutical and biotechnology organizations to map, analyze and continually improve the efficiency of operations by integrating them in a single platform of different management frameworks, including product design, regulatory affairs, adverse events, change management, electronic batch records (EBR), and supplier management, among others.

    By offering staff with insight in their role in end-to-end activities, they become better able to recognize opportunities for improvement rather than ending up fighting fires. Powerful support for collaboration with co-workers across organizational boundaries then enables them to play a central role in making smart improvements in the way the organization serves its customers.

    Read More
    Read More

    SoftExpert Suite simplifies and standardizes excellence and compliance management processes by providing an online platform that works as a central point of access for all up-to-date documentation, KPIs, policies, templates, procedures and tasks.

    • Document Control

      Document Control

    • Performance Tracking

      Performance Tracking

    • Project management

      Project management

    • Risk evaluation

      Risk evaluation

    • Manufacturing process

      Manufacturing process

    • Product data management

      Product data management

    Main Benefits

    Manage corporate performance from strategic to operational level.

    Increases regulatory compliance, through electronic document draft and approval, management of printed copies and audit trail.

    Reduce operational costs.

    Improve operational efficiency.

    Instantly share quality and performance data across the enterprise.

    Maximize costly resource investments.

    Standardizes and streamlines pharmaceutical and biotechnology processes.

    Ensures conformity with standards and regulations.

    Ensures on-time reporting and periodic reporting via dashboards, alerts, and notifications.

    Identify, analyze, evaluate, monitor and manage risks by automating safety surveillance and signal identification processes.

    Tracks reporting non-conformances into the quality management process for investigations and corrective actions.

    Brochure / Demo More Information Request a Live Demo
    Solution Overview

    Solution Overview

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    Know some success stories

    More Resources

    Featured Resources

    Ebook

    How to achieve Operational Excellence in the Life Sciences Industry

    Read this eBook to find out the eight pillars to help life sciences companies overcome barriers to excellence.
    Learn more
    DOWNLOAD

    White Paper

    Imperative for managing risk in pharma

    How to effectively manage the corporation’s reputation embedding risk management in their normal business practices.
    Learn more
    DOWNLOAD

    White Paper

    Process Validation: How many sample sizes do I need?

    The several factors that must be considered when determining the appropriate sample size for process validation.
    Learn more
    DOWNLOAD
    More Resources

    See also

    FDA 21 CFR Part 820
    SoftExpert Excellence Suite
    SoftExpert EQM
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    SoftExpert
    • Products
      • By business needs
        • Overview
        • Business Process Management – BPM
        • Corporate Performance Management – CPM
        • Enterprise Asset Management – EAM
        • Enterprise Content Management – ECM
        • Enterprise Quality Management – EQM
        • Enterprise Risk Management – ERM
        • Environmental, Social and Corporate Governance Management – ESG
        • Governance, Risk and Compliance Management – GRC
        • Human Development Management – HDM
        • Innovation and Change Management – ICM
        • Enterprise Service Management – ESM
        • Product Lifecycle Management – PLM
        • Project and Portfolio Management – PPM
        • Supplier Lifecycle Management – SLM
      • By industry
        • Overview
        • Aerospace and Defense
        • Agribusiness
        • Architecture, Engineering & Construction
        • Automotive
        • Chemicals
        • Consumer Goods
        • Education
        • Energy & Utilities
        • Financial Services
        • Food & Beverage
        • Healthcare
        • High-tech
        • Medical Devices
        • Mining & Metals
        • Pharmaceuticals & Biotechnology
        • Public Sector & Associations
        • Retail
        • Transportation & Logistics
      • By regulation
        • Overview
        • AS9100
        • BPMN
        • BSC
        • CBOK
        • CMMI
        • COBIT
        • COSO
        • FDA 21 CFR Part 11
        • FDA 21 CFR Part 820
        • FSSC 22000
        • GDPR
        • IATF 16949
        • ISO 10015
        • ISO 13485
        • ISO 14000
        • ISO 15189
        • ISO 19011
        • ISO 20000
        • ISO 22000
        • ISO 22301
        • ISO 26000
        • ISO 27001
        • ISO 31000
        • ISO 37001
        • ISO 45001
        • ISO 50001
        • ISO 55000
        • ISO 9000
        • ISO/IEC 17025
        • ISO/TS 14253
        • ITIL
        • OHSAS 18000
        • PMBOK
        • Six Sigma
        • SOX
      • All products
        • Overview
        • Action Plan
        • Analytics
        • APQP-PPAP
        • Archive
        • Asset
        • Audit
        • Calibration
        • Capture
        • Competence
        • Customer
        • Document
        • FMEA
        • Form
        • Incident
        • Inspection
        • Kanban
        • Knowledge Base
        • Maintenance
        • Meeting
        • MSA
        • PDM
        • Performance
        • Portfolio
        • Problem
        • Process
        • Project
        • Protocol
        • Request
        • Requirement
        • Risk
        • SPC
        • Storeroom
        • Supply
        • Supplier
        • Survey
        • Time Control
        • Training
        • Workflow
      • SoftExpert Excellence Suite
      • SoftExpert Excellence Suite
    • Services
      • Overview
      • Training
      • Cloud Computing
      • Consulting and Implementation
      • Customization Services
      • Integration
      • Performance Optimization
      • Service Hours Pack
      • Support
      • Validation
    • Company
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      • Contact us
      • Business Partners
        • Find a Partner
        • Strategic alliances
        • Become a Partner
        • Qualification Form
      • Careers
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    • Customers
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