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Enterprise Solution for Pharma Manufacturers
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The Pharmaceutical Industry is faced with intense competition, rise in input costs, poor infrastructure, price control by the Government etc. These are just some of the factors that threaten to reduce market share and profitability and bring generic drugs manufacturers to forefront. Growth in Revenue and Improvement in Margins is becoming more and more challenging due to ever increasing competition, government regulations, product segmentation, high lead time for drug development, probability of drug development failure etc. Successful pharmaceutical companies are looking to manufacturing software and technology to not only survive but also grow in these turbulent and changing times. These companies are utilizing software to streamline operations, reduce production costs, and be more responsive to demand fluctuations.
The pharmaceutical industry is increasingly complex. Customers seek better service. Shareholders demand profitability. The government agencies require that you keep current with regulations and follow them to the letter. In this environment pharmaceutical manufacturers are confronted with a number of unique challenges viz.
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Need for accurate and timely forecast of customer demands.
Capability to respond quickly to the availability and changes in raw materials.
More Market demand for innovative products at more competitive prices.
Ability to maintain brand equity and increase market position through superior quality and value added services.
Expiring patents on blockbuster drugs and insufficient new drugs in the pipeline.
Visibility to and analysis of real-time, enterprise-wise information throughout the supply chain.
Support creative, promotional pricing tailored to a region, class of customers, or product lines.
Many Regulatory, Security and Reporting requirements.
Continual streamlining of operation processes to minimize costs and maximize yields.
Control and optimize inventory levels to reduce carrying cost and maintain optimal inventory.
Adequate flexibility required being pharmaceutical industry highly dynamic.
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Great dependency on third party data since most Pharmaceutical Inventory is sold to wholesalers and not directly to the end customers, making difficult to analyze sales data, without third party information.
Faced with this dynamic landscape, pharmaceutical manufacturers must adapt to the marketplace while being responsive to changing customer preferences. Successful manufacturers are effectively and efficiently leveraging technology to respond to these challenges and to satisfy current demands while anticipating future requirements.
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QUADSTM is enterprise resource planning solution specially designed and developed for pharmaceutical product manufacturers. It gives a real-time view of the business and the information needed to make effective decisions.
A pharmaceutical company depends on data from every link in the supply chain: inventory receipts, quality control and quality assurance test results, payments for purchases, production records, customer orders, shipments and invoices, payments from customers, maintenance of equipment and facilities, investments and taxes, etc. QUADSTM is designed to reflect the particular needs of company business processes like items with multi-pack, multi-size finished goods, bulk storage and replenishment control management, shelf life and batch expiry control, product development and specifications, centralized and local purchasing.
QUADSTM is tailored to meet the needs of pharmaceutical industry. It can deliver the power, scalability, and robust e-business functionality in a cost-effective manner, with rapid implementation. QUADSTM comprises versatile analytics and MIS reports, which gives the power to run businesses at peak performance.
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Presents real time organisational status with improved visibility
Material costing, batch costing, product costing, WIP
Equipment calibration, preventive maintenance, equipment capacity utilization
Electronic batch record generation viz. BMR & BPR
Batch reconciliation, RM / PM / FG management with batch / lot control
Pre-configured Pharmacopoeia, Quality Groups, Tests, Calculations with efficient laboratory management
Vendor analysis / evaluation ensuring effective material procurement with pharmaceutical specific supply chain management
Sales tracking at primary & secondary level with sales & returns analytics
Sales force management with targets, achievements, incentives
Material distribution with comprehensive routing & rating details
Budgeting, Accounts Receivable / Payable, Treasury management
Effective HR & Payroll management
Intelligent messaging / alerts to manage workflow
Support to multi-location activities, sub-contracting
Compliance to specific needs of 21 CFR Part 11, FDA, cGMP, cGLP, WHO, eCTD etc (Not validated)
Supports Data Warehousing & Business Intelligence
Increased visibility of key performance indicators (KPIs) across portfolio
Effective User Administration & Security management
Use of cutting edge technologies
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Material Procurement process initiation from production planning department
Indicates Shortages of Material for execution of plan
Material procurement cycle Indent / Enquiry / Quotation with approved vendors
Quotation Comparison & Analysis
Purchase Order creation with facilities for imported, staggered deliveries, multiple currencies
Interface with Stores, Production Planning and Finance
Report on pending PO's and reminders to suppliers
Purchase Rate History
Vendor Analysis: Analysis of approved vendor on the basis of on-time deliveries, returns, quality of goods, rate and other purchase statistics
Vendor Rating
Purchase return management
Purchase rate variance against standard rate
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Goods Receipt & Inventory Management: Follow-on activity to purchase order
GRN captures information like vendor's batch, AR Number, date of manufacturing, expiry period / BBU etc. with online update of Physical Inspection Checklist
Generation of Quarantine labels and intimation to QC for quality control activities
Stock Status: The stock in a warehouse is categorized as Open, Quarantine, Under Inspection and Blocked
The Stock Statement is available for any desired material and desired period
Date Controls: The system keeps track of multiple dates at the batch level, including Expiration, Manufactured, Best Before, Shelf Life and Re-test
Generation of Requisition, Issues (RM / PM) and Dispensing are provided on FEFO basis
Assay calculation in material issue process for batch
Valuation of the inventory
Use of Bar Code readers, ABC analysis, FSN Analysis
Interface with Production, Quality and Finance (Accounts Payable) modules
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Batch planning, Equipment planning, including personnel planning for optimum plant performance and Work-in-Progress
Product formula / BoM: Enables to define formula consisting of Raw Material (RM), Coating Material (CM) and Primary / Secondary Packing Material (PM) for theoretical batch size of the product.
Facilitates to define various tasks / operations for Batch Manufacturing (BMR) and Packing Process (BPR)
Batch Planning: Enables planning of the batch on the basis of Production Plan and Sales Orders, blocking of material based on product formula, addition of recovery.
Production Process: Facilitates step-by-step entry of the batch manufacturing process maintaining complete documents for the same (adherence to cGMP). Allocation of manpower and equipment utilisation (Active / Passive) task-wise, facility to enter IPQC results for the task / operation.
Monitoring of Material Yield Product-wise, Batch-wise, Stage / Task-wise
Annual Product Review based on yield, hardness, weight, assay etc.
WIP / Recovery transfer: Transferring bulk, blend etc. to WIP warehouse and intimation to QC for testing
Valuation of the work-in-progress inventory including cost of raw material and value addition at each stage of production
Production deviations during manufacturing, Out of Specifications, Market Complaints etc
Interface with MRP, Quality, Costing, and Sales
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Enable the product quality performance monitoring and management
Maintenance of Pharmacopoeia, Quality Groups, Quality IDs, Tests, Standard Limits, Protocols and Method of Analysis
Define the test specification for the quality management during production (for IP, BP, USP and In-house etc.)
Quality of Goods Receipt: Quality Management / Batch Management, ensuring correct quality is purchased, QM inspection results against limits to verify acceptance of materials
Laboratory Integration: Integrated quality control, according to cGLP functionality like In- Process Quality Control on Standard, Storage or Order specific request for QC
Product Real-Time & Accelerated Stability Testing
Control Sample Management
Reagent maintenance: Date of preparation, expiry, re-test due for the reagent
Generation of Worksheets for chemist with sample and specification details
Labels printing Sampled, Under-test, Approved and Rejected with standard colour codes
Quick retrieval of Certificate of Analysis and Analytical Report
Rejection Analysis helps in improving Material and Supplier Performance.
Interface with MRP, Production, and Accounts Payable
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Calibration of Test Equipment: Automatic generation of calibration orders on a regular basis and execution with calibration instructions with maintenance of calibration report
SOP Management and alerts generation on reviews
Facility to maintain various audit details like discrepancies found, closure details, corrective & preventive action etc
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Cost centre: Definition of cost centres in the manufacturing process
Production cost per machine per hour includes parameters like OEM data, overheads, depreciation, interest, cost of planning, inspection, operation and power consumption etc.
Process cost determination, Process cost monitoring and Activity based costing and Plant capacity utilisation
Batch-wise, Task-wise Raw Material, Packing Material showing standard quantity vice-versa actual used with standard deviation
Batch-wise, Task-wise Recovery, By-product showing expected quantity and actually generated
Batch-wise, Task-wise manpower and equipment utilisation
Cost-centre-wise equipment utilisation for various costing parameters
Revenue & Cost Accounting: Provides valuation and recording of financial data as the basis for all cost- and revenue-related reporting.
Trend Analysis Process Cost
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Facilitates Definition of equipments in system, mapping important spares for stock purposes,mapping trained manpower on equipment for decision support
Equipment calibration, blocking of the same on due date and generation of alerts, maintenance of Log-book, Preventive Maintenance with maintenance history
Equipment qualification against Design, Installation, Performance and Operation, also generation of automatic alerts on situational basis
Generation of alerts upon changing important spares and due for Operational Qualifications
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Stock transfer between locations
Rating: Management of freight tariffs
Decision Support: Transportation Requirements Plan
Carrier Selection: System driven assignment of carriers against shipments based on compatibilities and freight costs.
Quick and Flexible order entry for variety of item types including kits, configurable products and services.
Customized treatment for pricing, tax and discounting mechanisms, to handle various commercial policies
Multiple order processing
Order booking / Pack-list / Invoice Generation
Product issue based on FIFO, FEFO, near expiry and selected batches
Scheme management for sales promotion
Return goods management - adjustment of customer balances and sales returns
Payment from Distributors and adjustments against Accounts receivable
Batch hold from invoicing
Interface with Production and Finance
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Maintenance of various statutory documents viz. RG23A Part I & II, RG1, PLA, ER-1 etc
Integration with Inventory, Sales & Finance modules
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Generation of various mandatory export documents along with Custom Invoice, Packing List, Form ARE-1 etc
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Integration of Warehouse, C & F Agents, Consignee Agents and Depots
Stock, Sample & Promotional Goods management
Tour planning and actual visit of MR with online generation of Daily Call Report
Personal Order Booking
Distributor management using maximum credit limit, minimum dispatch limit, maximum invoice value and hold transactions
Sales achieved product-wise / value-wise/ territory-wise, Region-wise, Zone-wise
Sales targets against achievements based on primary and secondary sales data
Retail counter Prescription Audit
Sales incentives
Interface with Sales & Distribution and Finance
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The general ledger module integrates with accounts receivable and accounts payable, covering budgeting, financial reporting.
Accept details of vouchers, cash, bank receipts and payments
Reconciliation - Bank reconciliation on regular basis
Financial Statement - Statutory and management reports like Cash, Bank, Journals, Credit / Debit Notes, Ledgers, Trial Balance, Profit & Loss and Balance Sheet
Ratio analysis, Cash / Fund flow
Accounts Receivable keeps track of Receivables with automatic data update from Sales Management system
Accounts Payable keeps track of Payables with automatic data update from MRP and QC
Payment Planning based on Purchase Terms
Distributor-wise ageing analysis is available
Sales Tax Register
Depreciation on fixed assets Statement
Interface with MRP, Production, QC, Sales, and Payroll
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Time Management optimises processes for planning, managing, and evaluating the working times and activities of employees.
Attendance and Leave management
Process employee wages and salary
Payroll processing includes Payroll Accounting, Dearness Allowance, House Rent Allowance, Tax, Insurance, Travel Expenses Administration, Incentive Wages, Posting to Accounts.
Statutory reports to Provident Fund commissioner office, Income-tax office
Salary advance, bank loan, employee society Management
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Employee increments
Employee training On Job / GMP / External, Preparation of monthly training calendar, results, grades, feedbacks
Employee demographic data for HR
Employee competency matrix with details like Experience, Qualifications, trained on SOPs, Equipments etc
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Menu-driven ERP administration to manage users, user roles / privileges
Security management (Module level, Page level, Operations level)
The audit trail can be viewed by the System Administrator
Any data entry or modifications are recorded by date, time, user, action
Security is available in multiple levels like database, object and instance. It controls user access from the initial login through to the final logout.
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The Package has been developed using cutting edge technology that gives the security and ruggedness to ensure its functionality in the prevailing conditions at the shop floor
Front-end PHP 5.0, JAVA
Operating System Windows
Web server IIS
Backend Oracle 10g XE
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QUADSTM is preconfigured with Quality Control Pharmacopoeia. Database contains Tests, Limits, Protocols & Method of Analysis which are readily available during testing process and documents are maintained as per WHO-cGLP as well.
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