Contact Us

North America

AX for Pharma North America LLC.
100 S. Ashley Drive, Suite 600
Tampa, FL 33602
United States

Europe

AX for Pharma Europe
Centro Direzionale Milano Due
Palazzo Bernini, 701-704
20090 Segrate (Milan)
Italy

Advanced Quality Management

Advanced Quality Management

Advanced Quality Management is part of our comprehensive pharmaceutical ERP and operations platform that provides health and life sciences organizations with a single integrated solution

Comprehensive Solution
Comprehensive Solution
Pharma ERP
Pharma ERP
Improve Productivity
Improve Productivity

Profit from one end-to-end quality management system with AX for Pharma ERP, powered by Microsoft. Avoid the pitfalls of a standalone and costly LIMS (laboratory information management system) that drains resources, is difficult to upgrade, and is convoluted when it requires updating information on disparate systems. One fully-integrated system means more productivity along with one source of data veracity.

“Our solution includes GMP manufacturing and supply chain capabilities, Advanced Quality Management (LIMS), Dispensing Module, and GMP Plant Maintenance and Calibration. What if you could address those challenges at a fraction of the cost you expect, with effortless integration across your operations? And what if the solution is based on the Microsoft stack, taking advantage of Dynamics 365, SQL Server, SharePoint, and Office?”

Andrea Ruosi, CEO of AX for Pharma,
  • Ensure accurate monitoring of the value of quality versus the cost of quality.
  • Gain real-time communication between departments using one data source.
  • Eliminate setbacks from duplicate entry with an all-inclusive solution.
  • Quality control and assurance that complies with GxP guidelines and regulatory requirements—specifically 21 CFR Part 11 and EU Annex 11.
  • Supplant manual approvals and physical documents with electronic processes that improve accuracy, suppress errors, and streamline the validation process.

Benefits

  • Sample management
    • Sample login
    • Statistical sampling plans linked to supplier qualification
    • Barcode labels
    • Retest/retain samples
    • In-process samples
  • Results entry
    • Multi-level tests based on mathematical functions
    • Reduced testing/skip testing
    • Results validation vs. internal and customer specifications
    • Test sheet and batch record management
  • Batch approval, release, and traceability
    • Configurable graphical workflow engine compliant with 21 CFR Part 11
    • Analytical review and quality assurance (QA) approval with electronic signatures
    • Parallel approvals for Biological, Microbiological, and Physical/Chemical tests
    • Conditional release
    • Batch management
  • Project management and accounting
    • Quality activities integrated with project management and accounting
    • Stability studies, product formulations, and analytical services
    • Value of Quality/Cost of Quality
  • Skill management and work scheduling
    • Skill management for quality, production, projects, maintenance
    • Quality Master Planning, including scheduling of quality control activities for purchased and manufactured items, to better plan the workload of the laboratory

Features

  • Sample management
    • Issue sample requests based on sampling plans with a statistical approach, taking into account the supplier’s qualification status, number of batches received, number of sub-batches or containers received from the supplier, and time intervals.
    • Support a full chain of custody with sample receipt and storage.
    • Generate barcode sample labels.
    • Manage retest, retain and stability samples and identify samples assigned to the different labs: samples for chemical testing, microbiological testing, etc.
  • Results entry
    • Create, modify, and approve analytical specifications, reducing paper-based approvals and documentation.
    • Utilize different types of tests and results: including options, numeric, and multi-level test criteria, and perform results entry, calculations and validation within the same solution. Test criteria consist of multiple steps requiring mathematical functions and support the different tests included in the US and European Pharmacopoeia.
    • Reduced testing and skip testing streamline and optimize inspections following a risk-based approach.
    • Validate test results against company and customer specifications to increase customer satisfaction, compliance with country regulations and productivity.
    • Generate Test Sheets that include testing procedures, methods and batch information.
    • Generate Certificates of Analysis for any type of product and material. Multiple certificate layouts can be configured by item, customer and country.
    • Automatic copy of test results from existing quality orders to reduce the risk of manual entry and speed up the process.
  • Batch approval, release, and traceability
    • A graphical workflow engine provides configurable processes for analytical approval, QA approval, and batch release by site, product type and other options. Workflows are integrated with electronic signatures and the daily work list that each employee accesses when entering the system. It is possible to implement parallel workflows secured by electronic signature.
    • Increase flexibility and reduce lead time for operations with a conditional release process for raw materials and intermediates.
    • Ensure full lot traceability and chain of custody with batch management from receipt to release.
  • Project management and accounting
    • Easily track costs and revenues: quality activities related to manufacturing and internal/external services are fully integrated with project management and project accounting.
    • Manage stability studies and analytical services, tracking quality results, time and costs.
  • Skill management and work scheduling
    • Apply skill management to quality, production, project and plant maintenance activities, enforcing compliance with GxP guidelines and regulatory requirements.
    • Track and maintain employee certifications, training records and skills within the system.
    • Production scheduling includes time needed for lab activities and quality inspections.
  • Compliance with 21 CFR Part 11
    and EU Annex 11
    • Electronic signature certificate includes limited validity period and user lock-out if a certificate is repeatedly violated, as required by 21 CFR Part 11 11.10, 11.200.
    • Secure batch review and approval processes with electronic signatures.
    • Apply audit trail and/or electronic signature requirements to GxP-critical fields and tables.
  • Supplier qualification
    • Define the qualification status of suppliers by item in the Approved Vendor and Manufacturer List by item, secured with electronic signatures.
    • The qualification status of suppliers is integrated with the receiving process, enabling to quickly determine the type of inspection and sampling plan that needs to be applied.
  • Quality reporting
    • Monitor the progress and status of quality operations in the Quality Role Center, where you can review batches and quality inspections by status, dates and many other drivers.
    • Batch statuses, samples and quality results in the Advanced Quality Management platform can be accessed via Excel using configurable queries, to easily build reports like Annual Product Reviews and charts. The data source of these reports can be refreshed in one click using the native integration with Microsoft Excel.
    • Generate customer specific Certificates of Analysis directly from the ERP solution. Each certificate is stored in the AX for Pharma solution and can be retrieved at any time.
  • Integration with the AX for Pharma
    full ERP solution
    • Reduce costs and accelerate time to benefit with native integration across all AX for Pharma modules, including the Dispensing Module for dispensing and assay management, GMP Plant Maintenance for instruments calibration, Activity-Based Product Costing, and Pharmaceutical Operations

Contact Us

North America

AX for Pharma North America LLC.
100 S. Ashley Drive, Suite 600
Tampa, FL 33602
United States

Europe

AX for Pharma Europe
Centro Direzionale Milano Due
Palazzo Bernini, 701-704
20090 Segrate (Milan)
Italy