Top 6 Challenges of the Pharmaceutical Manufacturing Industry & Their Solutions

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1 Attn: Pharmaceutical Manufacturers and CMOs Top 6 Challenges of the Pharmaceutical Manufacturing Industry & Their Solutions The pharmaceutical manufacturing industry is undergoing fast paced change in a highlycompetitive and regulated environment. As pharmaceutical manufacturing companies and contract manufacturing organizations (CMOs) mobilize to produce new drugs, improve and accelerate manufacturing processes, and manage their growth across national and international organizations - the complexities of their businesses are growing throughout their entire supply chain. The responsibility of managing the quality of their products is foremost, along with the challenge to remain compliant on multiple regulatory levels - all while growing a successful financial and operational corporation. Pharmaceutical Manufacturing and CMO(s) Top 6 Challenges: 1) Ensure delivery of high quality results (product/processes) on time and on budget 2) Scale operations for growth to produce new products, increase sales and meet demand 3) Traceability: maintain compliance with strict government and regulatory requirements 4) Effectively manage forecasting, planning, processes and inventory 5) Maintain operational visibility and track key performance data 6) Reduce operational costs

2 2 BPBD s New SAP Cloud-Based ERP Solution: Reduces Complications and Costs BPBD has worked with the world s largest enterprise application software provider, SAP, to develop an add-on package to Business ByDesign (ERP with a simpler implementation) for the pharmaceutical manufacturing industry that enables FDA CFR21-11 and EU Annex 11 compliance in the cloud environment. In the past, compliance certification has been onerous for cloud applications, but BPBD s new cloud-compliance solution package has solved this issue. With digital traceability through esign, validation of signatures, and process controls to enforce SOP, compliance requirements are efficiently met and with significantly less complications and costs. Solving Pharmaceutical Manufacturing & CMOs Challenges 1) Ensure delivery of high quality results (product/processes) on time and on budget BPBD unleashes its expert capabilities and deep product knowledge to customize the Business ByDesign solution to benefit your organization interdepartmentally and across the supply chain, manufacturing, and distribution. The cloud solution can be configured to hold as many required data fields as you need to ensure employees are not missing any critical data or skipping any regulatory steps. Together, we ll create a tailored solution that provides your team with the right data to comply with both industry and company specific standards. The upgrades to your organization will significantly increase your business efficiencies, consistencies and transparency. Consistent product quality is the culmination of the enablement of the organization through SAP Business ByDesign. Ensure high quality results on time and on budget 2) Scale operations for growth to produce new products, increase sales and meet demand Companies within the pharmaceutical and contract manufacturing industry need a customizable solution that automates key processes, streamlines inventory management, and provides real-time access to critical company information. SAP Business ByDesign is designed to grow with your company. One of SAP s leading Business ByDesign integrators, BPBD combines our proprietary methodology together with our in-depth industry experience to customize the application to your unique requirements. BPBD works to streamline and automate processes, affect quality control, create greater

3 3 operational visibility, simplify regulatory compliance, and effectively manage inventory. All of these improvements lend to operational visibility and the ability to optimally manage organizational performance and growth. 3) Traceability: maintain compliance with strict government and regulatory requirements Part of the FDA CFR mandates electronic signatures as a control mechanism for any logistics transaction which affects the product quality, or the health of the end user of the product. BPBD has designed a solution that provides electronic signature capabilities for transactions. It also validates the user and automatically attaches transaction documentation to each entry in the application. Given that companies in this industry must comply with strict regulations from the government, other industry standards, and their own company requirements - they need a tool with quality tracking functionality that is flexible and effective. SAP Business ByDesign also gives companies the opportunity to add extension fields to ensure that they are gathering all the information they need and that they are compliant with all regulations. Additional application functionality is available to help with quality tracking needs. For example, it is possible to set up routings to ensure materials are sequestered, and blocked for logistics use until properly inspected. This allows for more accurate and complete reporting in the future and gives executives insight on how their vendors are performing. BPBD has designed electronic signature capabilities for transactions that also validate users. 4) Effectively manage forecasting, planning, processes and inventory Most companies in pharma manufacturing have a complex bill of materials. They order and make only what they need to reduce inventory, carrying costs, and ensuring on-time delivery to their customers. The material resource planning (MRP) functions in SAP Business ByDesign can help improve forecasting and inventory management. The sophisticated forecasting tools allow executives to make important business decisions and ensure the company inventory is well positioned. SAP Business ByDesign also offers warehouse bin management and cycle counting to further simplify the inventory management process. Together these functions make it easy for employees to closely monitor supply and demand, and precisely manage it to inventory. These industry-specified tools also improve inventory control and enhance vendor relations. 5) Maintain operational visibility and track key performance data In today s world, information is available remotely -whenever you need it. The same kind of instant gratification should apply to the business world. Executives within the pharma and contract manufacturing industry want to be able to pull complete and real-time data about their business - at any given time and Business ByDesign delivers with access across devices.

4 4 With SAP Business ByDesign and its extensive Business Analytics, companies can pull countless real-time reports from virtually anywhere. Executives can set up dashboards with relevant business information to make informed decisions. Customized reports can be created and accessed via mobile devices, providing full visibility of business - at any time. These reports allow decision-makers to streamline their business operations and deliver pertinent information to staff, customers, vendors and much more. This means employees can go into work every day knowing the operational status of their portion of the business and what needs to be done that day. 6) Reduce operational costs Let s start with one of Business ByDesign s great benefits, reducing the total cost of ownership of a cloud ERP solution. With no hardware or hosting expenditures, only monthly subscription fees and reduced implementation times, your company is set to extract profit from the solution sooner. Mostly importantly, the bottom line is the benefits of Business ByDesign for the organization with business transparency to enable production, increased sales, profitability and your overall achievement of business goals and objectives. Case Study Highlights Global Pharmaceutical Manufacturing Co. - Headquartered in USA - Subsidiary in EU working with regional CMOs - Manufacturing and distributing to more than 30 countries Implemented SAP Business ByDesign for: Support of supply chain operations Multiple distribution agreements Customized and configured to ensure proper cross-country materials movement Headquartered in USA, this pharmaceutical manufacturing organization retains full control over the product, production recipe, and other master data. It tasks its subsidiary with manufacturing and distributing the product to more than 30 countries around the world. Business ByDesign was configured and setup to cover these areas from a supply chain planning and execution perspective, as well as being application-certified according to regulations specified in US CFR21, 11, and EU Annex 11. Several additions were developed and configured to ensure proper cross-country materials movements. With respect to corporate reporting, Business ByDesign was setup and configured to address both corporate and local reporting, as well as statutory reporting in different countries according to local GAAP.

5 5 Who is BPBD Specializing in SAP Business ByDesign, BPBD is led by industry professionals with more than 100 years of combined software experience. More than software implementers, we are your business partners, your engineers and your innovators dedicated to your needs. We are a dynamic collection of skilled individuals that strive constantly to create the world s best Business ByDesign implementation. Partnering with your company and leveraging our expansive network of industry specialists BPBD combines best-inclass practices, world-class experience and creativity to provide our customers with the SAP Business ByDesign foundation for their present and ongoing business processes. Born from a desire to provide the highest level of expertise and customer service, BPBD strives to not only meet but exceed customer expectations. Learn more about BPBD at BPBD and SAP Deliver a New Cloud-Based ERP Solution for Pharmaceutical Manufacturing & CMOs. Request a Demo Today About Business ByDesign SAP Business ByDesign is designed for mid to large-sized enterprises. It enables growing businesses within the pharmaceutical manufacturing industry to transform their organizations with this cloud-based enterprise resource planning application for real-time visibility into your company s operations and performance. SAP Business ByDesign provides one solution that is simpler to implement than competitor s and offers a lower total cost of ownership. Business ByDesign has over 94,000 users in 120 countries. BPBD has worked with SAP to develop an Add-On package that specifically meets the needs of pharmaceutical manufacturing companies for FDA CFR21-11 and EU Annex 11 compliance in the cloud environment. Meeting this certification requirement enables companies to move to cloud computing and substantially reduce IT costs, along with transforming their businesses to run leaner, accelerate their production and the adoption of new products. Learn more about this exciting new ERP cloud solution for pharmaceutical manufacturing organizations by contacting BPBD Working with SAP SAP, the world s largest provider of enterprise application software, has over 355,000 customers in over 180 countries. The company s vision is to help the world run better and improve people s lives. Who runs on SAP? 100% of the Dow Jones top scoring sustainability companies, 98% of the most valued brands, and 87% of the Forbes Global 2000 companies. Learn more about SAP at