CrisCon ERP, Integrated Business Software for Enterprises

Specifically designed for pharmaceutical / drugs manufacturing – An Overview

CrisCon is a functionally rich, integrated enterprise-wide information solution that can be deployed in pharma production units. A highly scalable and technologically superior system, CrisCon enables you to integrate all areas of your businesses and increase operational efficiencies across the enterprise. It helps you boost customer satisfaction through better control over costs and enhanced profitability. Designed and developed by Oasis Infotech, to meet the requirements of regulated market segments such as Pharma Production / API Manufacturing, CrisCon supports multi-division and other multi-department kind of organization structures. CrisCon’s flexible design and extensive parameterization allows it to cater to changing business requirements. In addition, its high scalability ensures that usage of application grows with the growth of the business. It is specially designed and developed for pharmaceutical product manufacturers. It gives you a real‐time view of the business and the information needed to make effective decisions. A pharmaceutical company depends on data from every part 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, financial accounting and taxes etc. and CrisCon is specifically designed to manage pharma specific activities like multi‐pack, multi‐size finished goods, shelf life and batch expiry control, product formula and specifications, centralized and approved purchasing. CrisCon Software comprises reports set and MIS, which gives the customers power to run businesses smoothly and efficiently.

Business Benefits

• A complete and integrated solution • Maximized productivity and efficiency • Reduced costs • Optimized processes • Technology to transform your business into an e‐business • Quick and easy implementation with best practices for pharmaceuticals

Salient Features

• Adherence to cGMP and cGLP • Supports multiple Divisions • Facilitates multiple currency transactions • Purchase management • production planning and execution • Sales management • Sales Analysis - representatives achievement • Compliance with statutory requirements of FDA, Local Taxes etc. • Can integrate with existing legacy systems • Audit trails for addition / modification or deletion • Batch Control from purchase of material to sales • Costing of product throughout the production life cycle • Exchange Rate variance (Foreign Exchange) • Balance Sheet with Schedules, Cash Flow & Fund Flow statements • Analytical reports with graphical presentation as MIS & DSS • Single‐window data capturing • Menu‐driven System Administration to manage Users, creation of roles/privileges, assignment of user‐rights and setting business rules • Security management (Module level, Form level, Operations level)

List of Modules

• Purchase management • Inventory Management and Control • Production Planning and Batch Management / BPR and BMR Maintenance • Quality Control and Assurance through Integrated LIMS • Sales Management • Financial Management • Payroll • Cost and Controls • User Administration

1. Purchase Management

Purchase management and material procurement process initiation from production department Indicates Shortages of Material for execution of plan Material procurement cycle Indent / Enquiry / Quotation with approved vendors Quotation Comparison & Analysis, the module triggers enquiries to approved vendors and captures information of quotations submitted by Vendors in response to these enquiries. Purchase Order creation with facilities for imported, staggered deliveries, multiple currencies Interface with Stores 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 purchasing statistics The status of the Procurement of the Material is available for review at each process stage in the Procurement cycle Purchase return management Purchase rate variance against standard rate

2. Inventory Management and Control

This Stores Management module automates the receipt, storage and issue processes from the Purchase Order generated by the Purchase Management module to the Manufacturing / Packaging Record. Materials are received from vendors at the Warehouse Stores at batch / lot levels and are placed in the quarantine area. Goods Receipt & Inventory Management: Follow‐on activity to purchase order GRN captures information like vendor's batch, AR Number, system keeps track of multiple dates at the batch level, including Expiration, Manufactured, Best Before, Shelf Life, Re‐test dates etc. Material, in excess of tolerance limits, is checked. Generation of intimation to QC for quality control activities, Quality Control (QC) draws standard quantities as samples and performs various tests based on the Pharmacopoeia grade and then approves / rejects the same. Stock Status: The stock in a warehouse is categorized as Open (unrestricted), Under Inspection / Analysis (restricted) and Blocked / on Hold The Stock Statement is available for any desired material and desired period Material Issue or Dispensing is according to stage wise Bill of Materials (BOM) that is defined for each product. Store generates a pick list and material tickets to facilitate materials moving to production. The system suggests an issue logic, which is based on ‘First Expiry First Out’ (FEFO), generation of Requisition and issues (RM / PM) on Potency basis after applying assay and LOD factors in issuance of materials. ABC analysis, FSN Analysis / Helps in reduction in unnecessary inventories The module also features extra usage requirements, usage returns, stock adjustments etc. Interface with Production, Quality and Finance (Accounts Payable) modules

3. Production Planning and batch Management

Product formula / BoM: Enables to define formula consisting of Raw Material (RM), Coating Material (CM) and Packing Material (PM) for theoretical batch size of the product. Materials resource planning on the basis of sales orders and routine production demands, system has provision to pull out three months advance planning of production batches accordingly requirement of raw, packing materials is generated to optimize and reduce inventory carrying costs where working capital in hugely engaged. Facilitates to define various tasks / operations for Batch manufacturing (BMR) and Packing Process (BPR) The Batch Manufacturing Record (BMR) and the Batch Packaging Record (BPR) is a stage wise capture of material inputs to the batch and the stage wise declaration of production output and yield. This BMR / BPR tracks the manufacturing process of formulation through its various stages – the system provides for capture of stage wise bill of materials. Excess materials consumed in the batch or returned from the batch are traced to the BMR / BPR. This facilitates the generation of stage wise batch cost. Production WIP is tracked at each stage in the manufacture of bulk and packaging. Hence Product batch wise WIP valuations are constantly available. 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 utilization task‐wise, facility to enter IPQC Results for the task / operation Monitoring of Material Yield Product‐wise, Batch‐wise, Stage‐wise WIP / Recovery transfer: Transferring bulk, blend etc. to WIP warehouse and Intimation to QC for testing Production cost per machine per hour includes parameters like overheads, depreciation, interest, cost of planning, inspection, operations and power consumption etc. Equipment calibration Valuation of the work‐in‐progress inventory including cost of raw material and value addition at each stage of production Interface with MRP, Quality, Costing, and Sales

4. Quality Management through LIMS - Laboratory Data Management

Enable the product quality performance monitoring and management Define the test specification for the quality management during production (for IP, BP, and USP 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 Calibration of Test Equipment: Automatic generation of calibration orders on a regular basis and execution with calibration instructions 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, Rejected etc 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

5. Sales Management and Analytics

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 Distributor management using maximum credit limit, minimum dispatch limit, maximum invoice value and hold transactions Sales targets against achievements based on primary and secondary sales data Interface with Material Distribution and Finance

6. 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, Balance Sheet and Profit & Loss 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

7. Payroll

Process employee wages and salary Time Management optimizes processes for planning, managing, and evaluating the working times and activities of employees. Payroll processing includes Payroll Accounting, Dearness Allowance, and House Rent Allowance, Tax, Insurance, Travel Expenses Administration, Incentive Wages, Posting to Accounts. Employee increments Statutory reports to Provident Fund commissioner office, Incometax office, Salary advance, bank loan, employee society Management Employee demographic data for HR Attendance and Leave management

8. Cost and Controls

Cost centre: Definition of cost centers in the manufacturing process Process cost determination, Process cost monitoring, Activity based costing and Plant capacity utilization Batchwise, Taskwise Raw Material, Packing Material showing standard quantity vis-a-vis actual used with standard deviation Batchwise, Taskwise Recovery, Byproduct showing expected quantity and actually generated Batchwise, Taskwise manpower and equipment utilization Costcentrewise equipment utilization 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

9. User Administration

Menu‐driven CrisCon administration to manage users, user roles / privileges Security management (Module level, Form level, Operations level) The audit trail can be viewed by the System Administrator CrisCon Software – CrisCon Solutions for Pharmaceutical Industry