The modern pharmaceutical industry came of age with the introduction of regulations demanding that new pharmaceutical products be proven both safe and effective before they can be marketed and sold. The consumption of allopathic drugs in Nepal in the Nepalese fiscal year 2056/057 (July 1999-July 2000) was somewhere to the tune of 79 million USD. The expected growth of pharmaceutical consumption by year 2005 is 186 million USD with annual increment of about 18-20%. At present only twenty six percent of the consumption is met by the domestic pharmaceutical companies. This reflects a wide scope of growth and development for the local pharmaceutical industry in the country.

But pharmaceutical industry face key challenges in today's sociopolitical and legal environment. Increasing competition, changing market scenarios and customer profiles, increasing awareness amongst end-users, and active regulatory enforcement on achieving World Health Organization recommended Good Manufacturing Practices (WHO GMP) guidelines are all forcing enterprises to be extremely competitive and at the same time offer high quality products and services. To add to this the increasing influx of the foreign products continue to present a very stiff competition to the local companies. This has made it imperative that enterprises rely heavily on information technology, enabling faster innovations, which are cost effective and help improve the bottom line. Data Analysis & Software Solutions (DASS) could be your ideal partner in delivering quick and innovative solutions ensuring you gain the much required competitive edge.

The software package, called PharmSys®, promises to allow pharmaceutical industries to integrate and streamline the processes from inventory management to QA/QC, in-process, production as well as maintenance and supply chain management. PharmSys® implements cutting edge front-end and centralized relational database ensuring the integrity of the system. Its access control mechanism and user authentication system allows controlled access to its features.

PharmSys® targets specific enterprise needs such as automated inventory management, automated document management and control, in-process control, quality analysis and control, deviation control, development of BMR, stability analysis, proper alert generation, maintenance scheduling, distribution/dispatch and can also address WHO GMP standards effectively.

PharmSys® is customizable. We are experienced in creating a wide range of customizations of the software, and consistently deliver them on time and within budget. We also offer a range of support services for PharmSys®, including training, support, data migration as well as hardware & software platform installation.

PharmSys® has been developed according to an industry standard software development lifecycle methodology and in conformance to our own stringent Standard Operating Procedures (SOPs) with due consideration of standards and specifications required to meet WHO GMP norms.

PharmSys® Key Features

1. Automated Inventory Management and Control.
   • Identification & Status indication of the received materials in the store. Eg. Generation of Green Slip, Yellow Slip for each container.
   • Alert generation for those items, which goes beyond the order level, and generation of purchase order.
   • Materials requirement planning as per the production plan and generation of purchase order to selected suppliers
   • Supplier rating on the basis of quality and delivery of supplies and selection of suppliers thereof.
   • Automatic generation of “requisition” and “dispensed tag” as per the standard / defined batch size and FIFO order.
2. Automated Document Management and Control
   • Generates document in the predefined formats (user specific), which reduces the nuisance of formatting the documents.
   • Document indexing, including storage/ updates/ retrieval of all Specifications, protocols, SOPs and Master documents.
   • Histories of the changed documents are stored which will be very helpful in reviewing the documents.
   • Management of sample received for bulk testing, RM/PM Testing, Retesting.
   • Consistency in documents as the reports & Batch records are generated on the basis of predefined templates
   • The access for the documents are designed in such a way that the generating, issuing, deleting, editing, printing and even viewing of the master documents needs a grant defined by the administrator.
3. Better In process Controls
   • The in process data are entered in the software which will then calculate and represent the results in tabular form. The results are interpreted by the software for rejection or acceptance.
   • The results are interpreted as per the test specifications of IP/BP
   • Batch Reconciliation is automated which will take the inputs from the different steps of manufacturing and assess the total yield. In case of deviation the software prompts for justification.
4. Proper Deviation Controls
   • Attributed to point 5 a. 5 b. and 9 c.
   • Prompt for “change control” system in case of change in normal procedure of dispensing.
5. Complaint Handling
   • Provision for complaint handling with reference to its production & QC analysis data.
6. Increased Productivity
   • During Production. Eg. Lesser the cycle time for document movement and retrieval, lesser time for in process analysis and recording, lesser reworks due to calculation and writing errors.
   • Automatic generation and control of BMR as per the process involved.
   • Generation of Identification tags indicating the stages of production for materials stored in containers.
   • In quality assurance. Eg. Less time in generating the documents, less time in retrieval and issue of documents, reduced typological error during generation of new documents.
   • Quality control. Eg. Effective control sample and tested samples management, less time for preparing the reports and slips (green slips and yellow slips).
7. Alert Generation
   • Planning, Scheduling and reminding the training programs and execution thereof.
   • Reminding of the maintenance activities to be performed.
   • Alert generation for the raw materials in case of retest date. And alert generation at least 2 years (can be changed as per users’ requirement) before the expiry.
8. Maintenance/ Utilities
   • Management of critical spares/consumables
   • Preventive maintenance planning and recording thereof.
   • System for breakdown analysis.
   • Generation of Preventive maintenance slips.
9. Distribution/ Dispatch
   • Statement of finished goods stock at hand.
   • Traceability of dispatched products according to the distribution
   • Stock Statement of Physician sample available
10. QC Analysis & Control
    • Stability Study Package
      • Provision for planning the stability Studies
      • Study Data recording and retrieval
      • Calculation of the data for shelf life.
    • Reference Standard Management
      • Provision for management of Reference Standard Management & Traceability
    • Test Report generation on the basis of analysis of data
11. MIS Reporting
    • Reports of daily activities on the basis of job completed (department wise)
    • Returned Goods/ Rejected Goods/ Breakage- Expiry recording and reporting
12. GMP related Information
    • GMP related information such as SOP formats, BMR, and guidelines for practice
    • Readymade information and data available all the time so that the records can be reproduced to satisfy audits at any time.
    • Save time and effort on managing required documents during processing work and reproduce the document during audit.
13. Support on Assuring Quality and consistency
    • The use of whole program would ensure uniformity in processing with proper record system.
    • This develops good confidence on management towards the control on operating processes for achieving assured quality products
    • The proper records and its availability at all the time would built company image in quality production with systematic processing principles.

PharmSys® System Requirement

Server Requirement
Hardware Requirements

• PC with 500 megahertz or higher processor clock speed recommended. (P III or higher processor)
• 256 megabytes (MB) of RAM or higher recommended (128 MB minimum)
• 500 MB of available hard disk space
• Super VGA (800 x 600) or higher-resolution video adapter and monitor
• CD-ROM or DVD drive (For software installment)
• Keyboard and Microsoft Mouse or compatible pointing device
• Windows compatible Printer
• Network Card

Operating System
Windows 2000, Windows XP or later Windows versions.

Other Requirements
SQL Server 2000 Enterprise Edition
Microsoft® .NET Framework version 1.1

Client Requirement
Hardware Requirements

• PC with 500 megahertz or higher processor clock speed recommended. (P III or higher processor)
• 128 megabytes (MB) of RAM or higher recommended (64 MB minimum)
• 100 MB of available hard disk space
• Super VGA (800 x 600) or higher-resolution video adapter and monitor
• CD-ROM or DVD drive (For software installment)
• Keyboard and Microsoft Mouse or compatible pointing device
• Windows compatible Printer (Optional)
• Network Card

Operating System
Windows 98, Windows ME, Windows 2000, Windows XP or later Windows versions.

Other Requirements
Microsoft® .NET Framework version 1.1

PharmSys® Development Team
The PharmSys® development team is comprised of cross section of experts including Pharmacist, Software Programmers & Engineers, WHO-GMP expert and Management professionals.

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