Microsoft Dynamics 365 ERP for Pharmaceutical Industry
Only in the pharmaceutical industry products are connected directly with the physical well-being and our health as the medicines, pharmaceutical products and medicinal products. Legislator and public authority therefore set up comprehensive regulations for the production and distribution of these products, which focus more and more on the integration of the ERP systems into the business processes. Meeting the physical requirements and legal regulations while keeping an eye on the own profit and competitiveness is one of the key challenges every pharmaceutical company faces. ERP systems as well as the entire IT-Governance therefore move in the focus of management to satisfying these conditions that these companies trust slim and non-conform methods and remain agile.
PHARMA
BIO SCIENCE
HEALTH INSTRUMENTS
CRO, CMO, CDMO
Complying with regulations
Having worked alongside pharmaceutical companies, we know that one of their greatest challenges is ensuring that products comply with a plethora of international laws and regulations. Microsoft Dynamics Pharmaceutical ERP software prompts companies, making FDA compliance a lot easier to achieve. Expensive paperwork errors are reduced, as are the number of preventable recalls. Quality management is reinforced at every stage through sample and batch management tools, accounting and work scheduling. Microsoft Dynamics contains the necessary functionality to ensure good Automated Manufacturing Practice.
Pharmaceutical ERP in accordance with GAMP 5
We develop and implement Microsoft Dynamics ERP systems according to the GAMP 5 recommendations published by the ISPE, which are certified for use in a validated environment. In addition to the actual software, we also supply SOP documentation and templates, so that the validation effort can be kept to a minimum when introducing a new ERP system in the pharmaceutical industry. A proven and established deployment method advances both the immediate project and subsequent commercial success.
Pharma Quality / Compliance
- Process & Resource Assessments
- Quality Remediation
- Policy, SOP & Batch Record Review, Preparation & Optimization
- Quality System (QS) Development, Assessment & Optimization
- CAPA Planning & Execution
- Training – FDA, EU, GxP, QSR & Design Control, Validation
- Internal Audit Programs
- QMS/DMS/TMS Implementation
Track and Trace
ERP Software for Pharma enables to determine a drug’s current and past locations. When track and trace is correctly implemented, a drug can be tracked throughout the supply chain and traced back up the supply chain upon return or recall.
In an effort to support track and trace for pharmaceuticals, serialization must be used to help identify a drug’s authenticity prior to sale, dispensing, return or recall. And, while a serial number provides a product with a unique identity, by itself, it is not enough to combat counterfeit, adulterated or expired medications from entering the drug supply chain. Serialized products must be supported by a number of other processes and data points, which are derived through track and trace.
Research and Development
Research and product development forms a huge part of any pharmaceutical company’s operation and the costs can rise exceptionally quick. Microsoft Dynamics budgeting forecasting modules ensure that inefficiencies and inaccuracies can be noted, and the budgeting and accounting is managed. The newly released Microsoft Dynamics 365 Operations, as well as the Dynamics AX and Dynamics NAV, Dynamics Business Central are all prime software choices to embed quality and visibility into your pharmaceutical operation.
Services Offered
Business Analysis
Requirement Gathering Workshop, Assistance in URS writing, URS Response, Functional Design Document
Software Customisation
Software Customisation, Code Review, Testing, Release Management, Change Management
User Training
User Training Seminars onsite, online, User Guides,
Scenario Walkthrough
System Validation
Installation Qualification
Production Qualification
Operational Qualification
Documentation support
Support & Maintenance
Support Desk, Ticketing System,
Remote Assistance,
Desk Sharing,
Support Portal
Pharmaceutical Manufacturing
Right from the R&D stage to delivering medicines to patients, the pharmaceutical industry has a close-knit connection with the physical well-being of humans. The various steps involved in this lengthy procedure require documentation at every step. Managing these records manually is a very tedious task. This is where ERP for pharmaceutical manufacturers comes to the rescue!
An ERP software for the pharmaceutical industry enables the integration and consolidation of pharma manufacturing processes across multiple units. It aids businesses with monitoring sensitive organizational operations such as compliance, quality, costing, formulation, yields and expiry management.
In an industry as dynamic as pharma, it is essential to have a system with stringent compliant practices. The ERP software helps pharma businesses to organize their procurement process while reducing production and delivery time. The key benefits that ERP offers the pharma industry include:
- Real-time bi-directional material traceability
- Batch tracking in WIP with yield reconciliation
- Effective management of BMR/BPR as per GMP
- Management Information Reporting at various levels
- Manage outsourced lab testing for microbiology tests
- Quality Management – IPQC, In-process inspection and Certificate of Analysis
- Wastage elimination through Expiry alerts & FEFO based material consumption
- Minimize the operational work through automatic alerts between departments
Pharmaceutical manufacturing ERP software is dynamically changing the way work is done. Supporting life sciences and pharmaceutical manufacturing, the ERP software also aids pharma businesses by:
Accelerating Product Development
The pharmaceutical manufacturing ERP software takes advantage of various time-saving tools and real-time actionable data to streamline pharma production. The product development process is accelerated by tracking the progress of samples. Multiple developers are allowed to work on separate formulae. The formulas are dynamically adjusted to meet physical and cost target values.
Timely Scale-up & Quality Check
Reversing the inventory for customer orders and scheduling batch jobs ensures a quick scale-up of production. Managing equipment, resource availability and capacities ensure that production related tasks are properly executed. Quality Assurance (QA) & Quality Check (QC) inspection, checklists and special instruction libraries are established to ensure the quality of production.
Compliance & Cost Control
Firstly, the ERP for pharmaceutical manufacturers identifies the cost of production, runs a cost analysis and consolidates demands using MRPs. Next, a masterbatch of records and other compliant audit reports is generated. This helps maintain full-fledged control over the cost and audit history.
Inventory Control
Lot numbers are auto-assigned during the production process. The variable characteristics of inventory are tracked, after which the appropriate inventory is selected based on:
- Expiry dates
- Certifications
- Current status
Inventory levels are then optimized using automated planning and procurement methods.
Planning & Scheduling
Determining a plan across horizons and calendars considers vendor delivery, order forecasts and planned production. Customer orders and prioritized and demand consolidation follows. Batch orders and runs are then linked & scheduled for generating synchronized purchase orders. This procedure gives access to real-time, accurate and actionable data.
Paperless Work in the Warehouse
Mobile warehousing through a pharmaceutical manufacturing ERP software facilitates paperless work in the warehouse with:
- Checklists
- WIP issues
- Inspections
- Adjustments
- Picking & shipping
- Warehouse transfers
- Receiving & put-away
Schedule a Free Consultation With our Business Transformation Expert!
Contact Us Now!