The document discusses the advantages of an integrated ERP solution for the pharmaceutical industry using Microsoft Dynamics AX. It summarizes that AX for Pharma 2012 is fully compliant with various regulatory requirements, enforces operating procedures and work practices, integrates key functionality like LIMS and plant maintenance, and supports a wide range of workflows to reduce costs and ensure consistency and compliance. The approach aims to significantly reduce implementation costs through a single team and minimizing customizations.

1. BUSINESS REQUIREMENTS
Manages the Prevents Enforces Automates Maintains
procurement of unsafe compliance to work production
raw materials products from regulatory processes for equipment and
needed for entering the requirements Quality machinery by
manufacturing supply chain, throughout the Management, scheduling work
as well as track manufacturing Projects, R&D, and shutdowns,
and monitor processes, manufacturing procuring
individual beginning with laboratories … maintenance
product units order release supplies and
and material managing spare
availability parts inventory
check, to
manufacturing
and packaging
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2. MODULES AX for Pharma Modules
Advanced Quality GMP Plant
Basic Pharma (BPH)
Management (AQM) Maintenance (GPM)
Activity Based Product
Dispensing (DIS)
Costing (COS)
Microsoft Dynamics AX Process Industries Modules
Manufacturing Distribution
Microsoft Dynamics AX Main Modules
Manufacturing Project Accounting Distribution
Human Resource Financial
Enterprise Portal
Management Management
Customer Relationship Supply Chain
Business Analysis
Management Management
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3. INDUSTRY CHALLENGES 1/3
Area Industry Challenge GxP
Item master Creation of a new item card with multiple approval steps and item √
usage restriction according to approval status
Sales Secure delivery of items approved by the customer in agreement √
with country regulations and customer specifications
Shipments Customer/item specific Certificate of Analysis, covering customer √
quality standards and country regulatory requirements
Purchasing Regulated material can be purchased only from approved vendors √
and after the completion of vendor audit and qualification
Production Production operations needs to be stopped in case of out of specs √
results during in process controls
Production Batch and expiry dates are calculated according to the intermediate √
product dates
Production Rework and reprocess orders with restriction of allowed operations √
and ingredients depending on order type
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4. INDUSTRY CHALLENGES 2/3
Area Industry Challenge GxP
Production Management of Master Batch Record √
QC Compliancy to statutory and regulatory requirements: √
1. Definition of internal and external specifications
2. Number of replications required
3. Statistical approach to testing (reduced testing/skip testing)
4. Test criteria
5. Sampling plans
6. Specifications approval process
QA/QC Possibility to manage QC and QA reports within the system √
QC QC quality order approval workflow different by item/item type with √
multiple levels of approval as required by GxP
Batch release QA review of analytical batch record and QP approval for the release √
of finished product to the customer
Lot 1. Restriction of changes of batch status allowed by role, following √
traceability the risk based approach of GAMP 5.
2. Verification of batch history and approval status of all
components of a manufactured product.
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5. INDUSTRY CHALLENGES 3/3
Area Industry Challenge GxP
Potency/ Calculation of Assay of APIs, Recalculation of Reservations, √
Dispensing Dispensing
Stability Management of Stability Studies, Cost of Quality √
Studies
Plant Management of GMP critical maintenance activities (e.g. cleaning, √
Maintenance calibration etc.) for laboratory equipment
Plant Possibility to manage preventive and corrective maintenance for √
Maintenance machinery and equipment
Plant Management of spare parts √
Maintenance
Plant Full traceability of the maintenance activities for each √
Maintenance machineryequipment
Documentation Documentation and Validation Methodology √
and Validation
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6. THE ADVANTAGES OF AN INTEGRATED ERP SOLUTION FOR THE
PHARMACEUTICAL INDUSTRY
AX for Pharma 2012
 Is fully compliant to EMA, US, and LATAM regulatory requirements (e.g.
FDA)
 Enforces operating procedures (e.g. GxP) and work practices
 Integrates or interfaces LIMS, Dispensing and Plant Maintenance
functionality
 Integrates laboratory data and plant maintenance activities with the rest of
the business
 Allows ERP users easily access to data (e.g. from laboratory and
maintenance) for reporting, result trending, workload assessment etc.
 Reduces the TCO of the ERP system
 Is a robust and adaptive platform
 Supports a wide range of workflows (e.g. item approval, purchase order,
quality order etc.)
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7. APPROACH
Our approach to enterprise solution architecture, design, development, integration
and validation significantly reduces implementation costs and enables companies to
work with a single implementation team, ensuring consistency, bringing savings and
achieving compliancy. These aspects, always important, become critical when the
validation of an extended ERP solution is required.
Working with carefully selected global partners, we help our partners and customers
understand their vertical and business needs and then provide the right solution fit,
while minimizing customizations and streamlining implementations
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