Pharmaceutical companies face challenges that go beyond standard Enterprise Resource Planning (ERP)
Complex operations, modern project management and quality management, adhering to stringent regulatory requirements - and many other opportunities. Companies often spend too much time and money in their quest to build and customize a system that meets their requirements and achieves FDA validation. There is a good solution. AX for pharmaceutical companies is designed to meet all the needs of pharmaceutical companies, minimize potential personalization and deployment problems, and provide you with expert advice and support from a trusted consultant.
MANAGEMENT OF THE INVENTORY AND STORAGE
- The item approval workflow includes automated selective blocking of non-approved items.
- Container / package management offers full traceability across batches and containers, including lifecycle changes and the status of batch secured by electronic signature.
- The approval of the article logs is secured by electronic signature.
- Manage conversions of batch units by batch analysis and activity.
- Manage approved customer lists (ACL) by item, batch, and country.
- Book batches that are synchronized with the relevant attributes and batch specifications defined by item and customer.
- Ensure approval by a competent person before transportation by electronic signature.
- Generate Approved Suppliers (AVL) and Manufacturers (AML) lists with comprehensive quality control for incoming goods.
- Ensure consistency through a structured vendor / manufacturer rating process.
MODERN MANAGEMENT OF QUALITY
- The quality approval workflow process provides users with a graphical interface, multiple levels of analysis, approval, and escalation guaranteed by electronic signature and conditional release.
- Powerful integration links stability studies and clinical and analytical services to project management.
- Rationalize selection management, reduce the number of tests, and make accurate plans based on a statistical method.
- Generate Certificate of Analysis by Item and Item / Client.
- Test multi-level mathematical criteria according to US, Middle East and Africa, Latin America, and Japan regulatory requirements.
- The Distribution and Filling Module includes integration with scales with serial or RJ45 connections.
- Sample management includes theoretical and real testing of pratids as well as automatic recalibration / scale change and reserve of components (active ingredients and auxiliaries).
- Ensure precision with scale, classification, and maintenance.
- Manage reprocessing and processing.
- Generate a production batch record.
- Save time and reduce printing by batch control in master data of the system directly related to the formula.
MAINTENANCE OF GOOD PRACTICE WORKS
- Management of preventive maintenance and repair of equipment through multilevel object control.
- Preventive and preliminary work assignments integrate with Material Resources Planning and the availability of equipment.
- Spare parts management for control and optimization of costs, consumption and availability.
- Full traceability of maintenance activities includes workflows and electronic signatures.
PRODUCT PRICE EVALUATION BASED ON ACTIVITY ASSESSMENT
- Calculate the full cost of the items, including direct and indirect costs.
- Opportunities include complete alignment with forecast sales and planned production, cost center budgets (quality, purchase, indirect production, etc.) and costs according to the production standard.
AGREED WITH 21 CFR PART 11 AND EU ANNEX 11
- An electronic signature has a limited validity and a lock on the user account if a certificate is repeatedly broken in accordance with 21 CFR Part 11, paragraphs 11.10, 11.200.
- Usage of security based dynamic-level lock and permissions.