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Home Industries Pharmaceutical
 
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Pharmaceutical


 

Whether you are a supplier of synthetic, botanical or biological pharmaceutical products, stringent quality, traceability and other regulatory compliance requirements means that tight control and visibility to all aspects of your operations is essential to quality control and maximizing your profits in a dynamic global marketplace.

Delivery of innovative products of consistent quality, as well as effective integration of new technologies are key to your continued success.

SYSPRO Enterprise Software provides the tools and flexibility to help you to meet the industry's challenges and capitalize on your opportunities.


Customer Testimonial: BioVectra

Manufacturer of specialty chemicals uses ERP to integrate operational and accounting departments; improving visibility for managers across the board.




Selected Case Studies

Control product formula changes

Constant innovation is one of the key factors to remaining competitive and on-going research and development to formulate new and better products is integral to the industry. SYSPRO's ECC, Bill of Materials, Work-in-Progress and Factory Documentation modules enable you to implement controls to ensure that your products are manufactured under consistent processes, to the correct formulae and specifications. Single-level, multi-level, co and by-product bills are all catered for.

Flexible bill definitions accommodate complex raw material and intermediary requirements to ensure precision in quantities required for bulks, batches and packs. You can define each structure level in a bill based on absolute fixed quantities, fixed quantities per, or wet weight percentages. Precision is further enhanced by SYSPRO's allowances for high tolerances in quantity definitions, as well as the number of levels catered for in a multi-level bill.

SYSPRO's Engineering Change Control (ECC) enables you to streamline and apply strict control over your design-to-market processes by providing a rules-based electronic workflow system with full version control, security and auditable history. ECC gives you the tools to record and track new and modified product formula and process changes, assess the impact of these changes on costs and associated data, and control the change routing and approval processes. ECC's queries, audit trail, history and archive facilities, give you quick on-line access to details of prior product versions, as well as the option of reverting to the production of a prior product version if required.

The Where-used Query facility enables you to identify all items affected by the raising of an engineering change order for all routes identified as being under engineering change control. In addition, SYSPRO provides a 'replace component where-used' facility that enables the quick replacement of one item with a valid substitute item, thereby streamlining formula changes.

Demonstrate stringent, accurate record keeping

Regardless of the regulatory and legal frameworks within which you operate, stringent records management for all business activities is a core requirement within the industry. SYSPRO's robust integrated nature provides a central repository for the secure retention, tracking and retrieval of your financial and operational records.

The SYSPRO Enterprise Analysis and Modelling framework promotes the on-line modelling, development, definition and publication of the blueprints of your business processes, structures and KPIs. This provides a Single Source of Truth (SSOT), ensuring a common understanding among the stakeholders, of the organizational goals, roles, activities and dependencies. Furthermore, a built-in workflow engine - SYSPRO Workflow Services (SWS) - enables you to embed standard operating procedures within SYSPRO, as well as to create efficient interactions between SYSPRO and external touch-points.

Powerful queries and reports provide structured retrieval of master and transactional details related to products and raw materials. Adherence to regulations in terms of product and raw material traceability is facilitated through SYSPRO's Lot Traceability and Serial Tracking features, including the ability to trace from source to finished product batches and vice versa. Visibility to the source of ledger data and KPIs is provided via reporting, as well as drill-downs from on-line financial reports, general ledger queries and digital dashboards.

History options enable the specification of on-line data retention, while electronic archiving enables the secure on-line storage and retrieval of past jobs, sales orders, recipe revisions and lot information. The archiving functionality extends to SYSPRO Reporting Services which facilitates quick and secure access to electronic copies of user-defined and system reports as they were run.

Full audit trails are provided for all transactions as well as master data amendments, while electronic signature capability provides tracking of who is doing what in the system.

Improve System Security

Much in the industry hinges on patents and licences. Research and development cycles are long and costly, so protecting the fruits of your research and development efforts, as well as that of any licensor is critical to your business survival. Security requirements range from ensuring safety, quality and compliance standards so that your reputation is not compromised in the marketplace, to the safeguarding of intellectual property in product formulas and processes. Critical to these requirements is the ability to secure organizational information from unauthorized access and fraudulent activity.

SYSPRO's security features are extensive, enabling you to strengthen the safeguarding of your electronic information. The Role Management capability helps you to streamline complex system administration tasks by providing centralized control of the design of security, eSignature and user interfaces, for companies, groups and operators. It also facilitates the identification of role conflicts, thereby assisting you in demonstrating to regulatory and compliance bodies clear lines of accountability and responsibility. It enables the definition of an on-line organogram to provide users with a visual overview of the your company's role structure and simplifies the assignment of the appropriate settings where staff switch or perform multiple roles.

Besides multi-level operator and group access control, SYSPRO provides electronic signature (ES) capability, which improves transparency and accountability in business transaction processing, giving you strict authorization and access control at a granular level. Not only do the ES features enable the logging of transaction agency and chronology in SYSPRO, but they also give you the tools to define rules around who is allowed to process specific transactions, and under what conditions. ES also enable you to configure notifications and other triggers to be fired off in the case of specific events.

SYSPRO Workflow Services help promote the seamless execution of multi-level control and approval processes, while e.Net Solutions provide the tools to facilitate secure version-independent integration to core SYSPRO with 3rd-party systems and web applications.

Manage complex and highly variable pricing and discount structures in international markets

Whether you supply pharmaceuticals, food or other fast moving consumer goods, your pricing strategies are built to accommodate a wide variety of customer types in wholesale and retail environments. SYSPRO enables you optimize pricing for a heterogeneous customer base, providing you with the tools to implement and manage your global pricing requirements, and to minimize the costs and effort associated with the administration of trade promotions and deductions.

Comprehensive sales data, along with powerful analysis, querying and reporting tools provide multi-dimensional analysis of product profitability to inform the pricing strategy process, whether it is cost-based, performance-based, market-based, or a mix. In addition, deriving accurate and competitive pricing for commodity or customizable products is easily facilitated by SYSPRO's powerful costing functionality and visibility. Different costing methods per warehouse, quotations, bill of materials, product configurator and what-if costing functionality enables you to derive cost-based quotes and pricing with confidence.

The system accommodates local and foreign pricing techniques, from manual and simple automated pricing to contract pricing and complex trade promotions pricing and discounting. Sales order entry and electronic capture is streamlined through pricing automation based on customer and/or stock code matrices, and contract pricing at customer and/or buying group level by product or product group. Discounted, foreign and quantity-break pricing methods are catered for, as well as profit margin controls. The import, export and global price update facilities enable seamless implementation of extensive price changes.

Essential for suppliers of retail and wholesale customers, SYSPRO's Trade Promotions module facilitates the creation of rules that govern pricing, promotions, special offers, and rebates, as well as improved promotions tracking. In addition, the system's powerful rebate, accruals and deductions management functionality promotes fast, accurate invoicing and reconciliation, and improved cash flow management. Optional integration to SYSPRO's General Ledger module facilitates complete management and reconciliation of associated financial transactions.

Manage product and raw material traceability

Whether a compliance-critical requirement, or an analysis tool for continuous improvement strategies, the traceability of products from material origins through manufacture to final destination, is a key system requirement in many industries.

SYSPRO facilitates the recording of traceability and quality data on materials and products from purchasing through inspection, manufacturing, manufacturing inspection, stocking and sales. The recording of expiry and shelf-life information is also facilitated and powerful queries enable both upward and downward searches by stock code, lot number and transaction type.

SYSPROls lot traceability and serial tracking functionality afford full visibility to the origins, build and customer destination of products and batches, thereby providing the means to rapidly trace and analyse the source of defects, should they occur. In addition, SYSPRO's Engineering Change Control module enables complete management and traceability of changes to product designs, while the Return Merchandise Authority provides consistent handling of product returns, as well as analysis data for improvement programs.

SYSPRO's integrated nature enables full backward and forward traceability, as well as comprehensive record-keeping to meet strict compliance requirements. Shelf-life management is facilitated through expiry dates and you can use SYSPRO's customization and custom form features to record other compliance-code dates, as well as to capture storage and transport compatibility codes.

SYSPRO's Quality Management System (QMS) enables the configuration and tracking of quality inspection points and metrics, to help ensure product quality and high production yields. Where a full QMS system is not required, the system can be configured to force sample, or full quantities of items through inspection processes, where detailed records of counts, inspection, rework, scrap, defects and returns can be recorded. Basic quality management is further enhanced through the ability to specify approved manufacturers for material supplies, as well as the ability to monitor supplier performance.

Tracking material involves knowing where it is at any point in time. In addition to SYSPRO's powerful traceability features, the system provides inventory management and visibility across multiple physical and virtual locations, as well as detailed tracking of purchase orders, sales orders, works orders, inter-warehouse transfers and available-to-promise quantities and dates.

SYSPRO's e.Net Solutions enable integration with scanning and RFID systems, to reduce processing time, as well as processing lags and errors, as material moves through the different processes.

Manage product recalls

SYSPRO provides the capability for the secure storage and fast retrieval of reliable integrated information to enable quick extraction when a product or batch recall is necessary. Adherence to stringent EU/ MHRA /FDA/TGA regulations in terms of traceability and recall procedures in industries, such as food, pharmaceuticals and medical devices, is facilitated through SYSPRO's lot traceability and serial tracking features. Multimedia capabilities enable the linking of relevant documentation and graphics to products and material, while custom forms facilitate the capture of essential traceability data relevant to your industry.

SYSPRO includes the facilities to trace items from raw material origins to customer, and vice versa, as well as the ability to identify the processor of every transaction or data change associated with the item, via Electronic Signatures. Full upward and downward searches and extraction of the integrated traceability data is provided by SYSPRO's powerful queries, and standard or user-defined reports.

Using SYSPRO's powerful traceability features, you can confidently identify the source of defects and quality issues, and thus limit recalls to defective product only. This prevents the need for total product recall and the associated costs and reputation impact.

Provide secure systems access for a mobile salesforce

SYSPRO e.net Solutions provide the capability to create applications for handheld devices (such as PDAs) to interact with your SYSPRO database through wireless connectivity via the internet. This means you can equip your mobile sales force with secure remote access while they are out visiting customers. They can check stock availability, and product prices, and perform real-time processing of orders and merchandise returns with the relevant documents being emailed directly to the customer. It also means that they can update the SYSPRO Contact Management System immediately with any issues and requests raised by customers.

Track research and development costs, as well as royalty accruals

Because the industry is R&D-intensive, tracking the costs of the lengthy product development cycles is essential to identifying true return on investment, as well as accurately calculating cost-approach royalties where applicable.

SYSPRO's Engineering Change Control functionality enables improved control over product development activities, while SYSPRO's Work in Progress enables the capture, costing and tracking of time and materials consumed in various business programs. For complex long-cycle projects, SYSPRO's Projects and Contracts module enables detailed analysis of activities and costs by user-defined section. This provides instant fine-grained visibility to project cost performance, and identification of sunk costs and cost reimbursement values, with the user-defined sections enabling clear differentiations between development phases, as well as own-versus-collaborative efforts.

Royalties that are based on a percentage of sales can be automatically calculated and accrued via the deduction and accrual functionality in the Trade Promotions module.

 
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