AX for Pharma Advanced Quality Management


In pharmaceutical companies, quality management is often centered in laboratory processes and is handled separately from the rest of the organization, with legacy systems based mostly on expensive best-of-breed solutions (LIMS or customizations) that are difficult to upgrade as quality control requirements evolve over time. Yet quality management increasingly has an immediate impact on all areas of the business: planning, manufacturing, project management and accounting, operational workflows, purchasing, and production scheduling. This separation between ERP and LIMS forces most pharmaceutical companies to invest time, resources, and money implementing add-on quality management solutions while trying to make them communicate with the ERP and other existing IT systems.

There is, however, a better option. Says Andrea Ruosi, CEO of AX for Pharma, “We provide enterprise to medium size pharmaceutical manufacturers with a single, integrated IT solution covering all of their industry specific requirements. 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 total operations system? And what if the solution were based on a sole technology stack, the Microsoft stack, taking advantage of Dynamics 365, SQL server, SharePoint, and Office, whereby all processes are seamlessly integrated?”

The built-in connection of information and processes ensures accurate monitoring of the value of quality vs. cost of quality, real-time communication between departments, and visibility that spans all business processes and functions.

Quality control or quality assurance processes comply with GxP guidelines and regulatory requirements, in particular 21 CFR Part 11 and EU Annex 11. You can replace paper-based approvals and documents with electronic processes that improve accuracy and simplify the validation process.

Further enhancements like Lab Instrument Integration are always in the works, to cover the full needs of pharmaceutical laboratories. The AX for Pharma Advanced Quality Management platform is being continuously extended to integrate with many more lab instruments: results entry time will decrease dramatically, thus reducing the risk of manual data entry.

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.
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.
  • 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.