QualityExpert

GLOBAL TRANSPARENCE AND INTEGRITY; FACILITATED INSPECTIONS.
Reduce risk and overall cost of global regulatory compliance. 

STREAMLINED HARMONIZATION
IN-BETWEEN SITES.

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

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Get rid of outdated and dispersed legacy tools.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.

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.

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.

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


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.

Our QualityExpert is part of the AMPLEXOR Life Sciences Suite and helps users effectively tackle industry-specific QA/QC challenges in R&D, Clinical, Regulatory, PhV, Manufacturing, etc. in an integral manner.


ONE EASY-TO-USE BUT
SOPHISTICATED USER INTERFACE


APPLICABILITY RELATED TO
DOCUMENTS AND PROCESSES


COMPLIANT WITH ALL
APPLICABLE REGULATIONS


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

 

SUPPORTS SELF-VALIDATION

 

LOCALIZATION INTO ANY LANGUAGE


PROVIDES EXTENSIVE SEARCH, REPORTING
AND ANALYTICAL CAPABILITIES

 

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

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.

 

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

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