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Enterprise Solution for Pharma Manufacturers

Need of time

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.

  • 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.

  • 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.

    The Solution

    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.

    Salient Features of QUADSTM

  • 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

  • Proposed Solution

    Material Procurement

  • 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

  • Inventory Management

  • 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

  • Production Management

  • 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

  • Quality Control

  • 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

  • Quality Assurance

  • 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

  • Costing

  • 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

  • Equipment Maintenance

  • 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

  • Sales & Distribution

  • 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

  • Excise Documentation

  • Maintenance of various statutory documents viz. RG23A Part I & II, RG1, PLA, ER-1 etc

  • Integration with Inventory, Sales & Finance modules

  • Export Documentations

  • Generation of various mandatory export documents along with Custom Invoice, Packing List,     Form ARE-1 etc

  • Sales Force / MR Management

  • 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

  • Financial Management

  • 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

  • Time Office & Payroll

  • 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

  • HR Management

  • 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

  • User Administration

  • 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.

  • Technology

  • 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

  • Preconfigured Solution

    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.

    Implementation Methodology

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