QUALITY and COMPLIANCE Life Sciences Services


QualityExpert is an integral, flexible, and enterprise-ready software that is unique and proven, which supports quality management processes as well as controlled documents, enabling life sciences companies to reduce regulatory risks and improve product safety and quality. One environment. One interface. One project. One vendor. One authoritative source of truth.

Achieve today and sustain tomorrow: regulatory compliance with the unique next-generation Quality Management Solution, which supports the management of regulated data, content, documents, processes, quality, submissions, and publishing. Use quality business templates to manage your local and global processes in orchestrated manner. Leverage our master data management capabilities to automatically link your quality-related activities to the respective data, documents, submissions, and products, and enable the self-validation of the solution. Use advanced reporting tools to easily assess the impact of a change or track the quality improvement processes. Available today on-premises and in the cloud.

FEATURES

QualityExpert is part of our Life Sciences Suite of solutions and is built on a unique and innovative Integral by Design, Modular by ImplementationTM architecture, which enables all of its modules to fit together seamlessly, utilizing common master product data layers. Depending on your organization’s needs, it can support either individual compliance-relevant processes or the entire enterprise compliance management spectrum. This unprecedented level of integrality increases the level of efficiency, promotes enterprise-wide standardization and enables the your business to reach the next level, resulting in lower complexity and costs, higher quality, and sustainable compliance internally , as well as increased quality and safety.

ONE EASY-TO-USE BUT SOPHISTICATED USER INTERFACE

SUPPORTS SELF-VALIDATION

APPLICABILITY RELATED TO DOCUMENTS AND PROCESSES

OCALIZATION INTO ANY LANGUAGE

COMPLIANT WITH ALL APPLICABLE REGULATIONS

PROVIDES EXTENSIVE SEARCH, REPORTING AND ANALYTICAL CAPABILITIES

CONFIGURABLE INTEGRATIONS 
(LDAP/AD, MDM, ERP, LMS, CRM, ETC.)

ADAPTABLE TO CHANGES IN ORGANIZATIONAL STRUCTURE

FEDERAL APPROACH (CORPORATE- AND SITE-SPECIFIC CONFIGURATION SETTINGS)

FLEXIBLE CONFIGURABILITY TO ACCOMMODATE FUTURE APPLICABLE REGULATIONS

FULL COMPLIANCE HISTORY OF DATA, PROCESSES, DOCUMENTS, AND CONFIGURATIONS

INTUITIVE BUSINESS INTELLIGENCE REPORTING

BEST TOTAL COST OF OWNERSHIP (TCO)

INCORPORATES BEST PRACTICES MODULES AS A QUICK START

EXTREMELY CONFIGURABLE AND AGILE IN ADAPTING TO NEW BUSINESS PROCESSES

MANAGEABLE BY CLIENTS

READY TO BE VALIDATED AND DEPLOYED WITHOUT EXPENSIVE CUSTOMIZATION

SUPPORTS EFFICIENT ENTERPRISE-WIDE COLLABORATION

BOLSTERS DATA STANDARDIZATION – NO DATA REDUNDANCY

ENSURES SIMPLE UPGRADES AND BACKWARDS COMPATIBILITY CONFIGURATION

GUARANTEES EASY AND FLEXIBLE MIGRATIONS, INTERFACES AND PROCESS AUTOMATION

BEST DESIGN FOR ON- OR OFF-PREMISES – NO NEED FOR INTERFACES BETWEEN SUBSYSTEMS

COMPLETELY SELF-RELIANT, AS IT IS INDEPENDENT OF APPLICATION, TENANCY, INFRASTRUCTURE, AND LOCATION

Effectively tackle industry-specific QA/QC challenges

BENEFITS OF AN INNOVATIVE SOLUTION

QualityExpert is an innovative solution which enables users to manage all QA/QC processes and related documents through a single user-friendly interface and in a single environment. It thus reduces complexity, lowers costs and promotes standardization, all while improving operational efficiency. It incorporates best practices into common quality processes. This highly and easily configurable solution assures flexibility for dynamic multinational organizational structures and offers out-of-the-box modules support following quality processes and documents.

QualityExpert ensures sustainable compliance through a rich set of functionalities that help companies meet their business needs, including quality assurance, deviation tracking, and non-conformance management.

Quality Assurance documents and processes
Quality Assurance documents and processes
  • Change management
  • Validation management
  • Policy/SOP management
  • Training records management
  • Incidents and complaint management
  • Action management (CAPA)
  • Audit management
Quality Control and Manufacturing
Quality Control and Manufacturing
  • Site master file
  • Supplier qualification management
  • Technical agreements
  • Production specifications relating to submission
  • Product quality review
  • Batch master records
  • Serialization
GLOBAL TRANSPARENCE AND INTEGRITY; FACILITATED INSPECTIONS.
GLOBAL TRANSPARENCE AND INTEGRITY; FACILITATED INSPECTIONS.

Reduce risk and overall cost of global regulatory compliance. 

STREAMLINED HARMONIZATION  IN-BETWEEN SITES.
STREAMLINED HARMONIZATION IN-BETWEEN SITES.

Unify understanding of globally applied definitions and processes, while keeping specific site-level processes in place.

Get rid of outdated and dispersed legacy tools
SOLID CONTROL OVER GOVERNED PROCESSES. REDUCED COMPLEXITY.

Get rid of outdated and dispersed legacy tools. Leverage from top-down perspective and drilled-down view on your company’s quality processes and KPIs.

LIFE SCIENCES SOLUTIONS

ProductExpert

ProductExpert is part of AMPLEXOR Life Sciences Suite. It is the first ISO IDMP compliant solution available on the market that enables users to meet IDMP related requirements.

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R&DExpert

R&DExpert is the most advanced and highly flexible solution, which enables users to efficiently manage R&D project and document management, including trial management. One environment. One authoritative source of truth.

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QualityExpert

QualityExpert is part of AMPLEXOR Life Sciences Suite. It enables users to manage all QA/QC processes and documents through a single user-friendly interface in one environment.

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RIMExpert

RIMExpert is part of AMPLEXOR Life Sciences Suite. It is a business intelligence tool designed to standardize the data management process across your company and product lifecycle.

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SubmissionExpert

SubmissionExpert is part of AMPLEXOR Life Sciences Suite. It is the most advanced solution that helps users create, compile, and manage regulatory submissions and publishing.

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