Ross Enterprise - Enterprise Resource Planning

To access downloadable materials on modules within Ross Enterprise’s ERP product suite, please visit the System Overview Data Sheets section of our Resource Library. In addition to the systems information provided there, we also invite you to visit our Resource Library for complimentary document downloads on a range of other topics in Life Sciences that may be valuable to you and your organization.

Financial Management

The Ross Enterprise, process-manufacturing specific Financial Management module enables you to effectively manage your business operations across multiple companies, divisions, and individual sites. Whether users are down the hall, around the globe, or both, Ross ERP is designed to meet the specific needs of any process manufacturer.

Ross Enterprise's Financials module is a central source of financial information that leverages data from the entire enterprise and helps you manage your critical financial processes from planning through decision-making. Incorporating proven industry-specific practices, the applications provide the flexibility and functionality to manage large multi-national enterprises, as well as small- to medium-sized businesses in dynamic business environments.

The Financials module seamlessly integrates with the other Ross Enterprise software solutions to streamline and automate manual processes and deliver the information you need to make informed business decisions across your global supply chain.

Flexible Financial Processes Match Your Business

Seamless Integration with Other Applications

Competitive Advantages

Manufacturing Management

Ross Enterprise's Manufacturing module enables process manufacturers to make informed, real-time manufacturing decisions, ensure quality, increase plant throughput, contain costs and improve delivery performance.

Fully integrated with the Ross Enterprise Financial Management module, process manufacturers gain the added benefits of comprehensive management of order-to-cash, manufacturing planning-to-execution and procure-to-pay processes. Specific components of the Manufacturing module include recipe and formula management, work orders, product costing, maintenance, materials planning, inventory control software, and production.

The Manufacturing module defines the production process, calculates and tracks product and job cost, and records all of the activities necessary to manufacture products. Stages of manufacturing are consolidated into a process specification, and actual cost rollups within the process specification are compared to standard job cost for each lot or batch produced. All manufacturing-related activities are tracked and charged to a job, which determines actual job cost and variances. General Ledger journal entries are automatically created for all transactions and the lot trace information is recorded from the manufacturing activities.

Some of the specific functions of the Ross Enterprise Manufacturing module include:

Quality Management and Regulatory Compliance

Ross Enterprise's software is designed with quality control (QC) and quality assurance (QA) as integral parts of each application. This gives you precise control over all materials and products, including co-products, by-products and end-products. Throughout your entire process, from formulation to production and distribution, Ross ERP enables you to be more diligent in batch scaling, date code tracking, shelf-life expiration dating, lot tracing, and yield optimization.

Quality Management

Additionally, using Ross ERP, you can define and measure customer quality specifications at critical steps in the process. You can maintain the quality of your processes and products within strict tolerances to minimize delays and associated costs, and ultimately better satisfy the expectations of your customers. Shelf-life planning capabilities enable you to optimize production scheduling, while inventory control software helps better manage the expiration of materials and finished goods and maximize the shelf-life of shipped products.

Integrated Regulatory Management

In addition, Integrated Regulatory Management capabilities help you streamline your compliance efforts in today's environment of increasingly stringent local, national, and international standards. Ross Enterprise helps to streamline compliance with the regulations from organizations such as the International Standards Organization (ISO), U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and others.

Specialized Capabilities

Specific capabilities are included in the software to address requirements related to lot track and trace, Good Manufacturing Practices (GMP), 21 CFR Part 11, FDA Validation, Hazard Analysis Critical Control Points (HACCP), Standard Operating Procedure (SOP) Modeling, Material Safety Data Sheets (MSDS), and others. From regulatory planning, to execution and documentation of results, Regulatory Management solutions automate critical functions and minimize the risks of non-compliance while balancing operational costs and margins.

Materials Management and Inventory Control

The Materials Management and Inventory Control functionality within Ross ERP provides the ability to manage and view materials and products across multi-company, multi-division, or multi-site environments. The materials management and inventory control modules enable users to manage materials, intermediate goods, or finished goods on the basis of defined characteristics such as shelf-life, pH, moisture content, and potency level.

This is some of the functionality in the Materials Management and Inventory Control module:

Maintenance Management

The Maintenance Management functionality in Ross ERP provides the current and historical data you need to control and effectively manage maintenance and facilities assets. Key functional areas and benefits include electronic management of work orders, integrated procurement and scheduling, work order status and alerts, detailed equipment records and specifications, preventative and predictive maintenance (PM), and integrated costing and charge accounts.

This is some of the functionality in the Maintenance Management module:-

Business Analytics

Provide the timely, actionable information needed to analyze key performance indicators and make better decisions. With Business Analytics, the detailed transactional and statistical data from your operations is captured, summarized, and available to support your decision-making process - and ultimately to help you improve the performance of your organization.

Data Collection

The success of any business is almost always based on how well your company can compete in your chosen markets. For process manufacturers, this means higher quality products, faster time to market, quicker inventory turns and reduced manufacturing costs.

To achieve these goals, you need real-time data that accurately represents the steps in the manufacturing process. With this information, tactical problems can be identified and be addressed immediately, along with trends that may require further process improvements.

Examples of streamlining inventory management with Ross ERP Data Collection include:

Automated Tracking of Materials

Radio Frequency (RF) data collection for receipt of raw materials, bin transfers, material picking and shipment confirmation eliminates the need for keyboard data entry.

Improved Accuracy and Productivity

Real-time interaction ensures that configured business rules are not bypassed. Validations of transaction data elements are performed for each transaction. The results are improved data accuracy and increased productivity gained from instant visibility, which enhance your operational performance.

Receiving

When vendor shipments arrive, the receiving operator scans the bar-coded materials to capture the purchase order number, part numbers and quantities received. The user is prompted for put-away locations or direct issue to the shop floor. Goods Receipt Notes (GRN) are updated as inventory is received. Product Detail labels can be automatically generated as needed.

Inventory

Material handling personnel can easily scan parts and locations to perform one- and two-stage transfers, issues, adjustments & returns, update inventories in real time, and eliminate paperwork and manual data entry. Cycle counting and physical inventory processes can also be streamlined. Cycle count items, inventory locations and bin contents can all be downloaded to the end user's terminal directly, without having to log onto the system.

Shipping

Verification of dispatch data is the basis for shipping automation. Dispatch notes may be downloaded to a portable terminal, to prompt shipping personnel for the items, quantities and locations to select; each data element is validated against the dispatch when scanned. Once confirmed, inventory is relieved, sales order lines are closed and billing is generated automatically. Customer-defined shipping labels can print automatically without manual entry.

Real-Time Shop Floor Visibility

Automated production and job reporting provides real-time shop floor visibility. By bar-coding the job documents, production personnel can enter labor and stage count data with little or no keyboard entry. Jobs are automatically updated with elapsed labor, machine time, and manufacturing completed quantities. Multiple job close and stage count functions may be performed via a single transaction, saving valuable time at the end of each job.

Business Benefits

You know better than anyone -- in virtually no other industry are the business and regulatory requirements as complex and critical as they are in Life Sciences. So what's the good news? Ross Enterprise is specifically designed to address both your current requirements and those you see coming in the future -- we bring you peace of mind around issues that keep you up at night.

Browse the list below for details on the business drivers that affect you and how Ross Enterprise solutions address them.

Regulatory Compliance

As biotechnology and pharmaceutical companies are held to increasingly stringent regulatory standards, overhead costs associated with compliance requirements have the potential to be overwhelming, particularly in areas such as Validation, ePedigree, SOX, DEA regulations for scheduled drugs, and 21 CFR Part 11.

Providing the right tools for the job, Ross Enterprise solutions enable you to minimize the risks of non-compliance while keeping your operational costs down to maximize profits and enable growth. Our applications reduce the effort, costs, and risks associated with compliance with governmental and industry regulations -- from planning activities to execution to documentation of results, our software automates your most critical functions. With all standard processes documented and all operations and results tracked and logged to support your detailed reporting requirements, you can:

This list serves as only a sample of how Ross software addresses regulatory requirements your business may be may be facing. But regardless of the specifics of your compliance scenario, we streamline and reduce the cost of your compliance efforts by providing the visibility and control you need by automating:

Recall Protection/Risk Mitigation

Present-day threats and potential costs associated with recalls have never been higher -- one recall can put you out of business. As companies seek to increase their control and in turn, minimize their risks, they discover that varied activities within and outside the organization must be considered, and operations up and down the supply chain must be addressed.

Ross Enterprise software helps you monitor, track, and control your critical resources, including activities and materials. Capabilities in end-to-end traceability provide flexibility to follow complete histories and audit trails, forward and backward, across the supply chain. Specification management and change management also provide the control and predictability you need to detect and address variability early in your process. When potential issues are identified, you can quickly determine the underlying cause, make the necessary corrections, and provide supporting documentation.

Ross Enterprise’s recall/lot trace capabilities are unique, and are the most robust in the industry. You can select a lot of material anywhere in the supply chain -- raw material, manufactured intermediate, reworked lot, or finished item -- and within seconds have a single screen or printed report that displays all of the following:

Product and Process Quality Control

Quality control (QC) begins with the validation and approvals for suppliers' ingredients, batch sizes, process specifications, and individual stages (or recipes in the stages), and extends across the entire Ross Enterprise software application suite.

In Ross Enterprise, controls are in place for purchasing from only qualified suppliers, for QC controls and record keeping of incoming receipts, for the restricted movements of "on-hold" and quarantined inventory, and for use of material in manufacturing that meets quality and expiration date standards configured by the customer. Quality also extends beyond manufacturing to the customer with controls for manufacture dates, retest dates, and "ship by" dates if customers have a mandatory shelf-life requirement.

Quality begins with control, and control begins with security. Within Ross Enterprise software, roles for every function in your enterprise are maintained to ensure only those with the proper training and access rights can execute specific transactions. Audit trails, automated workflows for limiting use of expired or "on-hold" material, and single and double eSignatures are all part of Ross Enterprise’s software.

Because Ross Enterprise software is designed with QC and quality assurance (QA) as in integral part of the process, quality can be planned and managed as if it were any other process. This enables you to predefine and measure QC at all stages in the process.

Operational Effectiveness

Pressures related to New Drug Applications (NDA), Biologic License Applications (BLA), reducing costs, conserving cash, and/or growing revenues compel Life Sciences companies to optimize operations. Reducing costs and streamlining begins with accurately collecting and accounting for the costs of the operations.

To address these requirements, Ross Enterprise software has extremely sophisticated costing models for First In, First Out (FIFO), Last In, First Out (LIFO), Standard, Weighted Average, and Actual Lot Costs. All costs can be captured for material, labor, machine, overhead, quality tests, waste streams, employee expenses, and allocations for inventory, manufacturing, research, and clinical trials. With visibility across all areas of the organization, from finance to R&D to manufacturing, companies can begin to fully understand and address how certain practices impact margins and bottom-line profitability.

Ross Enterprise software provides company-wide visibility through integrated information and capabilities to speed the flow of goods, eliminate waste due to costly shelf-life expirations and returns, and gain the efficiency necessary to meet product demand while keeping costs at a minimum. As an example, support for actual costing exposes all material and operation costs, including indirect costs or value resulting from co-products and by-products, so you can better understand how and to what degree margins are affected.

Competitive Advantage

The intensity and diversity of the Life Sciences competitive landscape is unprecedented. For biopharmaceuticals, threats may originate from upstarts and generic drug makers. These unanticipated competitors challenge established R&D-driven companies to speed time-to-market so they can adequately recoup investments. Branded and generic pharmaceutical companies face the complexities of buying groups and expansion penalties for pricing compliance for Medicare/Medicaid. The trend toward business alliances, including mergers and divestitures, partnerships, and other cooperative ventures, constantly reshapes the landscape. This ongoing reorganization undermines traditional sales channels and increases pressure for cost-cutting measures.

Ross Enterprise software enables Life Science companies to optimize product service and value, deliver high-quality products on time, meet customer and regulatory requirements, increase operational efficiencies throughout the enterprise, and embrace and leverage opportunities for business change. All of these areas are critical to compete effectively and continually grow your business as market demands shift and requirements change.

Focused on Life Sciences

From small emerging biotechs to billion-dollar drug manufacturers, Ross Enterprise offers Life Sciences companies software solutions engineered to meet their needs today while also ensuring scalability for future success. With more than 15 years experience providing enterprise software solutions for the Life Sciences industry, we know how to speak your language, and we know how to help you optimize your business operations.

To ensure the production and delivery of high-quality finished goods, Life Sciences manufacturers have to be able to effectively produce, manage, and track goods, information and resources across the enterprise and supply chain while adhering to increasingly stringent quality standards and regulatory compliance requirements. Success starts with effective management of products and the manufacturing process with Ross Enterprise applications.

An unwavering focus on Life Sciences coupled with complete commitment to your success - that's the way we've delighted our Life Sciences customers worldwide, and it's our bottom-line promise to you and your business.

So what's the bottom line? Ross Enterprise's focus in Life Sciences means value to you. We don't overwhelm you with prohibitive costs, functionality you don't need, or unending implementation times. But most of all, our focus means we understand you and the complexities of your world - we speak your language.

Ross Enterprise software offers you all the functionality your business requires - all under one roof! Browse the list below for some of Ross Enterprise's best-of-breed Life sciences applications, and click a link for details on the topic.

Outsource Collaboration

At Ross Enterprise, we realize there are endless scenarios that could describe how you outsource. Maybe you outsource manufacturing and distribution logistics to one partner and have the contract manufacturer responsible for everything, with you paying only for finished product. Maybe you have 15 or more outsource partnerships. Maybe you fall between these extremes and have multiple manufacturers, in cascading or toll processing supply chains. Whichever side of the outsource equation you're on, we understand it and we partner with clients in it every day.

Exclusively from Ross Enterprise
Your outsource activities require an enormous amount of data collection, and in companies like yours, many of these transactions are left on paper or transcribed into Excel or Access. Ross Enterprise's Outsource Collaboration (OSC) software addresses critical factors not addressed by these manual methods:

But we're not exaggerating when we say that Ross Enterprise's OSC application gives our Life Sciences clients a combination of capabilities that aren't available anywhere else in the market, including:

Project Accounting

At Ross Enterprise, we recognize the complexity you face in addressing increasingly stringent corporate governance requirements, such as Sarbanes-Oxley Section 404, International Financial Reporting Standards (IFRS), Generally Accepted Accounting Principles (GAAP), and Government Accounting Regulations.

Designed by and for Life Sciences practitioners, Ross Enterprise's Project Accounting software provides you with a centralized source for reported project information across the organization; creates standard scheduling, costing, and monitoring of project progress; and enables efficient and effective overall management of projects and portfolios.

Designed exclusively for the Life Sciences industry, our Project Accounting application offers critical features to bring your business what it needs:

Contracts & Chargebacks

Time pressures, transaction volume, and requirements for data accuracy combine to make managing chargebacks a significant challenge for many Life Sciences manufacturers. Managing currently active Group Purchasing Organization (GPO) contracts with memberships numbering in the thousands while also processing manual and electronic chargeback submissions can be overwhelming for small to mid-size manufacturers.

In fact, studies indicate that for most pharmaceutical manufacturers, nearly one-fifth of chargeback lines are handled manually, underscoring the need for software that not only automates processes but also ensures data quality, decreases overpayments, and provides the audit trails mandated by regulatory requirements. That's where Ross Enterprise solutions come in!

Specific chargeback challenges addressed by Ross Enterprise's software include:

To address these and other challenges, the Ross application provides:

By automating the chargeback validation process and having up-to-date information on contracts, prices, and memberships, pharmaceutical manufacturers ensure that only valid credits are authorized and processed, reducing both the amount of labor they expend, and the volume and amount of their unauthorized deductions. Because each un-validated chargeback erodes the manufacturer's margin and quickly amounts to significant financial loss, the stakes are high. To address these and other challenges, Ross Enterprise offers its proven, cost-effective Chargebacks application, designed specifically for Life Sciences manufacturers.

SOX Compliance

At Ross Enterprise, we know that when it comes to Sarbanes-Oxley (SOX) and other regulatory mandates, the role of financial information systems in enabling compliance can't be overstated. In fact, most studies indicate "financial systems and procedures" are the most common problem among companies disclosing material weaknesses.

To address these and other issues, Ross Enterprise software provides Life Sciences companies with the financial systems foundation and best practices necessary to create the secure, auditable, and controlled environment needed to achieve SOX compliance.

Key Controls Processes
How can financial systems successfully enable and enforce SOX compliance? Most auditing firms point to six specific areas to carefully consider when evaluating a financial system's ability to support SOX compliance efforts:

Advantages of an Integrated Approach
Ross Enterprise's software is an integrated planning, purchasing, payables, receivables, sales, inventory, quality, manufacturing, and accounting system. That means journal entries are automatically posted to the ledger from the subsidiary modules, requiring no human interaction, uncontrolled interfaces, or manual re-keying of data -- all of these represent a significant advantage in compliance efforts, as integrated systems eliminate untested/uncontrolled points of entry.

While financial systems in and of themselves cannot automatically ensure compliance, they provide businesses with the foundations and best practices necessary for creating a secure, auditable, and controlled environment -- one in which financial reporting and performance can be easily measured.

Validation & Compliance Management

Life Science manufacturers walk a fine line as they try to balance the implementation of quality and regulatory compliance processes without breaking the bank. Using Ross Enterprise software to automate document control systems, corrective action and preventive action (CAPA) processes, training control, and other quality management initiatives, manufacturers are finding the results they've been looking for.

Ross Enterprise provides integrated quality and compliance management software systems for FDA and ISO regulated industries. These are the areas of Quality and Compliance Management our integrated software systems focus on:

Ross Enterprise provides easy-to-use, integrated quality and compliance management solutions that help companies automate FDA and ISO-based quality processes. More than just a software company, we also offer implementation, training, and validation services to maximize our customers' efficiencies and savings.

Radio Frequency Identification

Whether you need a short-term tactical Radio Frequency Identification (RFID) application to meet customer compliance requirements or a long-term strategic RFID solution that addresses demands for improved product tracking, traceability, and labor productivity throughout your supply chain - Ross Enterprise has what you need. Users of our practical, cost-effective, RFID compliance solution see reductions in retailer chargebacks, improvement in supply chain visibility, and subsequent increases in sales.

Flexible & Scalable
Our RFID2Go solution is an electronic product code (ePC)-compliant application that integrates seamlessly with Ross Enterprise's enterprise and supply chain product suites. Built to be both flexible and scalable, RFID2Go supports the practice of applying RFID tags to products during the receipt process, while in storage, and just prior to shipping. As process manufacturing specialists, Ross Enterprise works closely with our clients to ensure that these "Slap and Ship" and "Tag to Stock" practices align with your unique business, manufacturing, and distribution environments.

Ensuring 100 Percent Readability
Ross Enterprise Consulting Services ensure that client products, cases, and pallets achieve 100 percent read rates. Using automated scientific testing and analysis tools, the selection and configuration of tags, tag placement, and readers can be accelerated, saving significant time and cost.

Leveraging RFID ePC Data
Customer and manufacturing orders requiring RFID product compliance drive RFID2Go tagging process. Integrated into the Ross Inventory Control module, RFID2Go validates downloaded order and line item requirements, and controls the tagging process to support "tag at receipt" and "tag to ship" practices. To support "tag to stock" practices, clients can manually pull product from storage, tag cases and pallets using RFID2Go, and then restock the product. Enhancing our clients' enterprise and supply chain applications, RFID2Go not only supports customer RFID compliance requirements, but also improves product tracking and traceability in the supply chain by leveraging collected ePC read data.

Good Manufacturing Practices

In order to ensure the safety and efficacy of pharmaceutical products, the FDA mandates that manufacturers follow a set of methodologies and procedures known as Good Manufacturing Practices, or GMP. These guidelines are the FDA's way of regulating production processes that are constantly changing as new technology enters the scene.

Although specific regulations governing pharmaceutical production are often not feasible when dealing with novel technologies, GMP guidelines establish best practices as they evolve and also provide for extensive record keeping that helps reviewers determine the best way to make a drug. Manufacturers turn to GMP guidelines for direction on how best to perform laboratory processes such as calibrating instruments, preventing contamination, verifying drug stability, and labeling pharmaceutical products.

The FDA has defined current GMPs in 21 CFR 210 and 211. These mandates require drugs to meet quality, potency, and purity standards. In addition to delineating the required characteristics of drugs, GMPs also mandate specialized training and lab environmental controls such as instructions for ensuring freedom from vermin, instructions for how to build and maintain clean rooms, directives on how to house and handle lab animals, and strict policies for compliance.

Preconfigured and On Demand Solutions - Life Sciences Suite On Demand

What if you had an on demand solution that enabled you to cost effectively deploy infrastructure to meet 100 percent of your business and compliance requirements, and gave you all the benefits of traditional software with low cost, low complexity, and virtually no risk?

We know for growing life sciences operations, it's almost cost prohibitive to deploy infrastructure, buy software licenses, and pay staff to manage the systems critical to your businesses success. But the real question is, why would you do it if you didn't have to? Your business is about bringing your drug to market. Our business is about making your path to success affordable, simple, and virtually no risk.

Our Life Sciences Suite On Demand removes business, financial, and regulatory risk for emerging businesses that need to operate in validated environments. Check out the side-by-side comparison of our managed software service solution versus a typical software as a service (SaaS) option for life sciences businesses like yours.

On Demand Solutions
We know that On Demand solutions are having a major impact on the software industry - they're changing the way people build, sell, buy and use software. Simply defined, this model offers software deployed as a hosted service and accessed over the Internet.

CDC Software has partnered with Vantage Systems to offer a best-of-breed, fully managed enterprise solution that is tailored to the unique needs of life sciences companies including the need to:

Life Sciences Customers

At Ross Enterprise, we know that our success depends entirely on the success of our customers. In the life sciences industries, Ross Enterprise's customers range from single-plant companies to larger multinational companies. Their industry segments include: