AX for Pharma is the most advanced and rapidly growing integrated ERP solution on the market today, successfully meeting the unique industry challenges of the pharmaceutical industry.
What are the reasons for such impressive success in North and South America, Europe, and soon in the Far East?
We, the team at AX for Pharma, believe that the market has immediately recognized the unique combination of factors on which this solution is build. The Pharmaceutical Industry has recognized that this unique solution is very hard, if not impossible, to achieve with legacy IT applications. Ax for Pharma offers distinctive features very difficult to imitate by any other ERP solution on the market today. The unique combination of factors include:
1. Focus, commitment and passion
The AX for Pharma team have applied a concentrated, iron-disciplined focus and commitment to achieve nothing less than excellence in the creation and development of the solution.
2. Competence and expertise
Competence and expertise specific for the pharmaceutical industry and its global needs, and the capacity to put these skills into action through our comprehensive services to our customers. Extraordinary services are provided by listening and understanding what our customers require to run the business and offering the right integrated solution.
3. Specialist IT knowlege
Proficiency and knowledge of the IT technology at all levels. This has enabled the team to make the best possible technical choices, from the innovative Dynamics AX platform to the use of state of the art IT tools.
4. Investment of resources
Even in the difficult economy of the last few years, the AX for Pharma team has devoted all the necessary resources to develop AX for Pharma with a unique architecture and features, comprehensively addressing the key needs of the Pharma Industry. The team has refused any compromises and/or hybrid solutions that so often characterize the IT market.
Results: Better Performance at Lower Costs
The integrated solution AX for Pharma can be purchased at a fraction of the cost of individual software variables purchased separately. Cost savings range from software to the expertise and consultation, to the implementation templates, and many more. The customer can select among various modules that fit their specific needs or can be graduated in time.
In addition to the functionalities provided by Dynamics AX for process industries, the fully integrated AX for Pharma ERP solution for the pharmaceutical industry covers the following specific functional areas:
- A complete review and, when necessary, the revision of the software to ensure that complies with the regulatory requirements and GxP guidelines of 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 moduleto 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, which is scheduled for release in late spring 2014, your company can ensure efficiently 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 (AVL) and manufacturer (AML) lists, backed by quality control integration for incoming goods.
- Ensure consistency with a structured vendor/manufacturer qualification process.
- 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 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
Ax for Pharma is supported with a variety of knowledgable documents on pharmaceutical production and validation. You are invited to view our extensive resource library, simply follow the link below.
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