AX for Pharma is the most advanced integrated ERP solution on the market today, successfully meeting the unique challenges of the pharmaceutical industry. And with satisfied users in the Americas, Europe, and – soon – Asia-Pacific, AX for Pharma is being rapidly adopted by competitive-minded companies around the world.
Why such success? The market has recognized that this unique solution provides capabilities that are difficult, if not impossible, to achieve with legacy IT applications – and that other ERP solutions will find hard to match.
The value that AX for Pharma provides is driven by a unique combination of factors:
FOCUS, COMMITMENT, AND PASSION
To achieve nothing less than excellence in the creation and development of AX for Pharma, we have applied an iron-disciplined focus, commitment, and passion.
COMPETENCE AND INDUSTRY EXPERTISE
We listen to our customers, understanding what they need to run their business. Then we apply our competence and expertise specific to the global pharmaceutical industry in order to offer them the right integrated solution and provide comprehensive services.
Our extensive expertise in information technology at all levels has enabled the team to make the best possible technical choices, from the innovative Microsoft Dynamics AX platform to the use of state-of-the-art IT tools.
INVESTMENT OF RESOURCES
Despite the difficult economy of the past few years, the team has devoted all the resources required to develop the unique architecture and features of AX for Pharma. Comprehensively addressing the key needs of the industry, the team has refused any compromises or hybrid solutions that so often characterize the IT market.
RESULTS: BETTER PERFORMANCE AT LOWER COSTS
AX for Pharma can be purchased at a fraction of the cost of individual software applications and components bought separately. Additional cost savings accrue through implementation templates, our consulting expertise, and much more. Customers can select solution modules that fit their specific needs and spread the acquisition of modules over time.
In addition to the functionalities provided by Dynamics AX for process industries, the fully integrated AX for Pharma ERP solution covers the following specific functional areas:
- A complete review and, when necessary, the revision of the software to ensure that it complies with the regulatory requirements and GxP guidelines for the pharma industry
- Advanced Quality Management for Microsoft Dynamics AX, supporting your quality management processes and requirements
- The Manufacturing Execution System module for dispensing and scale management
- GMP Plant Maintenance for Microsoft Dynamics AX, supporting your regulated Enterprise Asset Management processes
- The AX for Pharma FDA Validation Package, supporting a simplified and cost-effective system validation
- The Activity-Based Product Costing module to calculate the full cost of items, including direct and indirect costs
- Corrective Action Preventive Action (CAPA) Incident Management, which enables you to increase control, correct and prevent issues, measure the outcome, and continuously monitor the system. With our CAPA module, scheduled for release in late spring 2014, your company can ensure efficient compliance and effectiveness.
Single Integrated Solution
AX for Pharma combines Microsoft Dynamics AX with industry-specific solutions and capabilities such as Manufacturing Execution System, Advanced Quality Management, and Enterprise Asset Management. Rich pharmaceutical expertise and best practices fuel successful system implementations and FDA validation.
Comply with GxP guidelines
Achieve full compliance with international guidelines and regulations, including 21 CFR Part 11 and EU Annex 11. Drive consistent compliance by tracking GMP operations such as lot status, work order processing, batch releases, and quality control approvals.
Implement Advanced Quality Management
Integrated quality assurance controls include non-conformances management, quarantine, quality orders, sampling plans, reduced/skip testing, acceptance criteria, certificates of analysis, and batch records. Activity-based product costing enables careful monitoring for both direct and indirect costs.
Promote best practices across your value chain
GxP-compliant development, manufacturing, inventory, and supply chain management support rework activities, co/by-products, contract manufacturing, in process quality, container/sub-lot management, skill management for manufacturing, and quality and project management.
- Manage approved customer lists (ACL) by item, batch, and country.
- Reserve batches that align precisely with batch attributes and batch specifications defined by item and customer.
- Secure Qualified Person approvals before shipment with electronic signatures.
- Generate approved vendor list(AVL) and manufacturer list (AML), backed by quality control integration for incoming goods.
- Ensure consistency with a structured vendor/manufacturer qualification process.
- The complete Dispensing module includes integration with scales with serial or RJ45 connections.
- Assay management includes theoretical and actual batch assay, along with automatic recalculation/rescaling and reservation of components and ingredients. Ensure continuous precision with scale management, calibration, and maintenance.
Inventory and Warehouse Management
- Item approval workflow includes automated, selective blocking for unapproved items.
- Container/sub-lot management offers full batch and container traceability, including batch lifecycle and status changes, secured by electronic signature.
- Inventory journals approval is secured by electronic signature.
- Manage unit conversions by batch according to the actual batch assay and potency.
- Manage reworking and reprocessing activities.
- Generate production batch record.
- Save time and reduce paper-based activities by managing master batch records within the system, automatically linked to the formula version.
GMP Plant Maintenance
- Manage preventive and corrective equipment maintenance with multi-level object control.
- Preventive and ad-hoc work orders integrate with Materials Resource Planning (MRP) and equipment availability.
- Manage spare parts to ensure monitoring and optimization of costs, consumption and availability.
- Full traceability of maintenance activities includes workflows and electronic signatures.
- Quality order approval workflow equips users with a graphical interface, multiple levels of review, approval and escalation secured by electronic signature, and a conditional release process.
- Robust integration connects stability studies and clinical and analytical services with project management.
- Streamline sample management, reduce tests, and produce accurate sampling plans based on a statistical approach.
- Generate Certificates of Analysis by item and item/customer.
- Test criteria based on mathematical calculations with multiple steps in compliance with US, EMA, Latin American and Japanese regulatory requirements.
Compliance with 21 CFR Part 11 and EU Annex 11
- Electronic signature includes limited validity period and user lock-out if a certificate is repeatedly violated, as required by 21 CFR Part 11, Paragraphs 11.10, 11.200.
- Use extensible, dynamic record-level security and permissions to define access rights and functions for a user group and document status.
Activity-Based Product Costing
- Calculate full costs for items, including direct and indirect costs.
- Capabilities include full alignment with sales and manufacturing forecasts, cost center budgets (quality, purchasing, indirect manufacturing, etc.), and product standard costs.
AX for Pharma Fact Sheets
GMP Plant Maintenance Fact Sheet
Dispensing Module Fact Sheet
AX for Pharma Fact Sheet
Advanced Quality Management Fact Sheet
AX for Pharma is supported with a variety of insightful documents on pharmaceutical production and validation. To view our extensive resource library, simply follow the link below.