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LIFE SCIENCES SOLUTION

Life Sciences Software: SAP Life Science Solutions

Stay Compliant, Safe, & Ahead of the Curve in the Life Science Industry

Accelerate Operation Performance

Life science companies come to Navigator when they find their ability to grow and/or adapt is being limited by their current business processes and systems. Navigator helps accelerate operational performance through digital transformation in life sciences software, so our clients can drive innovation, grow their business, become a leader in the industry, and increase market share.

“Overall, with the help of Navigator consultants, we’ve reduced our work probably on average 30% within the finance department alone.”
- Leah Peene, Business Analyst at CeloNova BioSciences

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A Tier One Software Platform Is Needed To Meet Regulatory Compliance Requirements

Life sciences companies are at the center of today’s healthcare and medical global supply chain disruption. They are navigating a dramatic increase in demand, rapidly changing expectations from global partnerships, and increasing competition from start-ups looking to capture industry market share.

They manage a complex and globally-based supply chain on a daily basis. This requires companies in the life sciences to have real-time visibility; going beyond price and availability to include the necessary quality and regulatory aspects of materials.

global supply chain with sap business bydesign

Ready-To-Validate Cloud Platform

Navigator Business Solutions offers a unique digital solution that meets the requirements of your life sciences company regardless of business life-cycle stage; from R&D start-ups, early-stage clinical trials, and scaling to full commercialization. Life science solutions combine a ready-to-validate (Validation Services) cloud platform with years of life sciences industry experience to deliver a fully 21 CFR Part 11 compliant solution.

“With a validated and scalable ERP system, the company is advancing its vision to build the world’s largest cell and gene therapy manufacturing and testing facility and enable the rapid development and delivery of groundbreaking treatments for patients,” said Peter Carbone, COO, Center for Breakthrough Medicines

The solutions are built on the fully integrated SAP Cloud ERP, enhanced with additional specific functionalities that help life sciences organizations optimize their supply chain, comply with business and industry requirements, improve forecast accuracy, drive operational efficiency while meeting Good Manufacturing Practices (GMP) including DSCSA compliance support.

How do quarterly ERP software updates impact FDA Validation [Blog]   

Prepare for growth with data business solutions that scale with you, stay compliant with built-in approvals & process flows, and improve quality control with pre-design quality levels.

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LIFE SCIENCE SUCCESS STORIES

“I think it speaks well to the knowledge and the experience that Navigator brings to the table, as well as being able to quickly migrate in a fast-paced environment.”
Marc Garofani
CFO
BIODERM, INC.
BioDerm implements SAP Business ByDesign

LIFE SCIENCE SUCCESS STORIES

“With a validated and scalable ERP system, the company is advancing its vision to build the world’s largest cell and gene therapy manufacturing and testing facility and enable the rapid development and delivery of groundbreaking treatments for patients,”
Peter Carbone
COO
Center for Breakthrough Medicines
Center for Breakthrough Medicines implements SAP Business ByDesign with Navigator Business Solutions

LIFE SCIENCE SUCCESS STORIES

"We can run reports upside down, inside out, any way you want it, you can get a report to tell you what the numbers look like. We now have all the information in one system – from CRM to the end of finance, we have tracking on everything we need."
Leah Peene
BUSINESS ANALYST
CELONOVA BIOSCIENCES
CeloNova BioSciences implements SAP Business ByDesign with Navigator Business Solutions

LIFE SCIENCE SUCCESS STORIES

“We told Navigator that we wanted their out-of-the-box, best practices for pharmaceutical companies"
Scott Harris
VP of TriRx
TriRx Pharmaceutical Services implements SAP Business ByDesign with Navigator Business Solutions

We’ve Helped Other Life Science Organizations Meet Their Goals

Configurable cloud-built ERP software, specific for Life Sciences Organizations

The question of why your local or global life sciences company may need ERP services is usually brought up by the growing pains your company is experiencing.

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You may be currently experiencing trouble with:

  • getting approvals & maintaining FDA compliance
  • closely monitoring expense management & full visibility over expenses related to projects and trials
  • meeting demand & accurately forecasting sales with reliable data
  • growing into a full ERP; taking on sales, manufacturing, production planning, quality management, & more when the commercializing process begins

5 Ways ERP Services Are Helping Growth-Oriented
Biotech, Pharma, and Life Sciences Industry Organizations

Handling business complexity and rapid technological changes are real challenges for life science businesses, especially biotech, medical technology, and pharmaceutical companies. However, by integrating robust ERP software into their business platform, these companies can streamline their production processes while also maintaining regulatory compliance and setting the stage for long-term life science success.

Companies in the life sciences today need to deal with a complex business ecosystem, including R&D, safety, regulatory compliance, quality control, intellectual property management, testing, sales, and marketing. They also need to chart a strategy with advanced digital technologies like artificial intelligence, deal with new manufacturing processes and techniques, understand the fallout from healthcare industry reform, take on global competition, and shorten time to market.

The integration of a cloud enterprise resource planning (ERP) solution enables organizations to lay out a digital foundation for future growth without a big upfront investment. ERP life sciences solutions can also reduce complexity as they scale up their business - or upgrade to a new digital system without interrupting existing operations. During the ongoing COVID-19 pandemic, the life sciences industry remains at the forefront of society’s hopes—and can achieve greater agility with the capabilities of an ERP for life sciences digital services.

Let’s look at five ways in which ERP services can help support the growth of biotech and pharmaceutical firms.

Regulatory Compliance

ERP systems empower organizations to achieve business growth, helping them gather information and meet all necessary quality and compliance requirements. An ERP solution can be configured for the unique needs of the life sciences sector and enables the organization to enhance its business model to meet industry standards and government regulations.

These capabilities help firms such as the Center for Breakthrough Medicines, an innovative contract development and manufacturing organization focused on cell and gene therapy services. The Center for Breakthrough Medicines is committed to regulatory compliance and cGMP-compliant services delivered by applied research, development, and manufacturing science and technology experts. And they lean on ERP services to get there.

Inventory Management

ERP software enables pharmaceutical companies to improve their use of raw production materials, reduce wasted costs and overstock, and increase the efficiency and accuracy of procurement, management, and replenishment.

By integrating an ERP platform with warehouse management software like Loxodo, businesses can increase the accuracy of their orders and get real-time data every day for better order management.

ERP can be interconnected with third-party logistic providers and EDI systems, leading to improved supply chain management.

Quality Control

For businesses juggling different laboratories and third-party manufacturing facilities, quality control is critical. ERP systems accommodate regular quality control tests, result tracking, and process validation.

By adopting an ERP system, organizations can also improve their production standards.

For example, the Center for Breakthrough Medicines has dealt with multiple third parties in various advanced, complex laboratories and production facilities while maintaining exacting quality standards.

Sales Controls

An ERP system can dramatically improve sales team performance. It can automatically produce sales quotes, notify agents when to contact prospects, track customer histories, programmatically transfer information to sales orders, and help unify marketing with sales, among many other user benefits.

In an age where automated and digital processes are as important as people skills for effective sales, ERP serves as the foundation for modern life sciences selling.

Financial Visibility and Reporting

The use of an ERP platform enables life sciences businesses to record historical data, facilitating seamless audit checks and document analysis with accurate information. For businesses with operations in various countries that must cope with multiple currencies and taxation regimes, ERP systems offer the financial team and top management visibility into overall business operations. ERP services also offer a holistic view of reporting as integrated real-time data, reducing redundancy and duplicated data.

An integrated ERP solution helps streamline the overall processes of the whole organization and makes it possible to connect with third parties for a comprehensive supply chain, resulting in increased overall efficiency, accuracy, and productivity. This gives companies the agility to quickly adapt to new industry opportunities. ERP also makes it possible to get real-time information and analytics, improving profits and efficiency.

Using a cloud ERP system that’s pre-built for specific industries can help organizations save implementation time and costs. Simple, scalable modular features that support a high-growth business will minimize the risk that a large and time-consuming IT project will end in failure; the shortened implementation time for this kind of ERP platform reduces the opportunities lost due to disrupted operations and production.

Navigator Business Solutions offers a unified system built to support and scale with the unique needs of life sciences firms. SAP solutions delivered by Navigator serve as the ERP platform and is accompanied by an innovative implementation approach that facilitates FDA validation with best-practice Standard Operating Procedures (SOPs) that enable customers to go live quickly and achieve full GMP on a timeline that may exceed their expectations.

Learn more about how this unique ERP software is designed to meet the needs of executives, accounting personnel, management, IT departments, operations, and even quality and regulatory control staff in the life sciences space.

Learn more about the Biotech FDA approval process.

Resources

ERP Evalutation Guide, Life Sciences Edition
Are you exploring ERP options? This guide will help walk you through all the questions you should consider when selecting the right solution for your company.
See our Industry-specific Cloud ERP Solutions in Action

Watch an on-demand demo now

SAP ByDesign an ERP Solution for Growth-Focused Life Science Companies

A guide for pharma, biotech, medical device, or contract manufacturers

9 Reasons Why SAP Business ByDesign is Designed for Life Science Companies

ByDesign is fundamentally well structured to support a validated environment

Explore Our Life Science Partnerships

Navigator has productized solutions that support the most common integration requirements through a single interface for all integrations providing for a more stable environment that is easier to maintain.

SAP ERP Solutions for Global Life Sciences Companies

SAP Business ByDesign for Life Sciences

SAP ERP DELIVERED BY NAVIGATOR

We at Navigator believe that our client's success depends upon understanding their Life Sciences focus well enough to help them achieve their goals.

We know your research and science are just as important as the business side of your organization. We're committed to helping you solve business challenges and create opportunities in the life science industry through technology. We're here because our clients need us; they trust us to help them grow their business. The key to building this understanding is knowing the life sciences industry and the detailed process and business issues related to each segment, and how an organization can use technology to keep up with the fast-paced nature of the industry.

Leveraging cloud ERP, Navigator Business Solutions helps growing Life Sciences companies access better visibility into their business, position themselves for success, and help manage and control the costs involved in research, trials, and commercialization. We know and have been building on top of the industry-leading SAP solutions for years now to support every business phase - from start-up and early research, into trials, and through commercialization, M&A, or an IPO.

Leveraging the SAP ERP Solution and specially developed industry extensions, we can work with you to implement technology that fits your organizational needs where you are and provide a robust platform for your company's continued growth.

Whether a pharmaceutical, biotech, medical device, or contract manufacturer, the demands of life sciences companies change as quickly as science. This type of dynamic industry requires an agile and scalable ERP solution, like SAP ERP. The correct ERP solution will help manage common challenges, track and trace requirements, provide real-time visibility into expenses and revenue, and provide tools for consolidation and reporting all within a validation-ready system.

Navigator's SAP ERP life science solution offers the best of SAP’s functionality, knowledgeably configured and implemented to meet the needs of life sciences organizations where they are today and scale with them into future growth. The ERP solution that fits your company's needs will allow your whole organization to focus on science, growth, efficiency, visibility, and compliance.

businessman hand shows gear business success chart concept

Services

Navigator brings more than ten years of experience delivering services and solutions to improve the way you work with flexibility & scalability to bolster the efficiency of your entire enterprise no matter the size

Our services, innovative solutions, and direct approach help you support:

  • Complex supply-chain visibility; Better Track & Trace Materials & Transactions
  • Compliance with FDA: CFR 21 Part 11
  • Global Project Management, Collaboration & Project Cost Functionality
  • Out-Of-The-Box Regulatory Compliance and Quality Control Functionality
  • CAPA (Corrective Action Preventive Action)
  • Recall Management
  • Electronic Signatures
  • Supplier & Internal Quality Audits
  • Plant Maintenance
  • Multi-Location Support: country, company, language, currency, taxes, GAAP, and industry regulations
  • Designed for GDPR Compliance

All services are delivered through a thoroughly tested digital implementation process provided on a fixed scope and fixed price, which minimizes risk and maximizes the opportunity for success.

Implement quickly with industry-specific ERP

RAPID IMPLEMENTATIONS

We have done numerous implementations of SAP ERP for life sciences companies and bring leading practices based on those past implementations as part of our life sciences packaged solution. With this expertise, we are able to get companies up and operating on the correct enterprise resource planning (ERP) system sooner and at lower costs.
SAP ERP grows with your organization

SCALABILITY

SAP ERP, a cloud-based enterprise resource planning system, provides a scalable solution that will grow with the organization as it progresses toward commercialization and beyond.

As you grow, life sciences manufacturing efficiencies are critical for upstream and downstream operational success. 

take control of your life science company with cloud erp

CONTROLS

Auditable change controls, configurable approval workflows, and user roles allow for the segregation of duties with strong internal financial and change controls providing for SOX compliance promoting investor confidence and Track and Trace as well as 21CFR part 11 requirements. Recommended tools and processes will improve the speed of your financial close and provide data transparently throughout the organization.
Project tracking in sap erp

PROJECT TRACKING AND LIFE SCIENCES ANALYTICS

SAP ERP solutions provide project tracking functionality, including time and expense entry and budgeting. It also helps track research and development and capital costs across your organization.

Make use of your data with life sciences analytics capabilities that help improve outcomes throughout your pipeline. 

support multiple entities, multiple locations, multiple currencies, and multiple languages

GLOBAL FINANCE

General ledger, payables, fixed assets, and cash flow are the engines that drive most transactions. The SAP ERP solution is designed from the ground up to support multiple entities, multiple locations, multiple currencies, and multiple languages with robust consolidation reporting features. With built-in system tools to help budget, plan, and forecast financials, inventory, and supply chain.

SAP Business ByDesign is a future-proof design to support inventory, sales order processes, research and development, and additional commercial operations down the road.

COMMERCIALIZATION

When the time comes and the commercial model has been developed for your product/service, we can optimize it to support your interactions with contract manufacturing organizations (CMO), third-party logistics providers, and procurement vendors. There is no need to implement another toolset to support future growth. Our supply chain professionals can help develop additional new processes to support your expanding business (through natural growth or acquisition). The SAP ERP solution provides a future-proof design to support inventory, sales order processes, R&D, and additional commercial operations down the road.


The benefits of an SAP ERP implementation for Life Science organizations:

  • Migrate from an on-premise solution to an audit-ready compliant cloud solution
  • Fixed cost and fixed time implementation model
  • Save time and dollars with partial remote solution implementation
  • In line with GMP Guidance, ERP can support IQ, OQ, and PQ validation and quality protocols
  • The phased implementation approach leaves the solution established and stable from the beginning 
  • User training allows for a smooth and quick adoption post-launch
  • Host entire solution without disruption to compliance processes with stable and secure Advancing Research and Clinical Practice (ARCC) hosting

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