With patient health at stake, biopharmaceutical companies today are under intense pressure to bring new drug therapies to market quickly. Compounding this pressure, especially for small and midsize businesses (SMBs), is the need to be prepared for dramatic growth once approval from the FDA occurs.
Meeting FDA regulations throughout the product lifecycle is the next hurdle; a hurdle particularly hard for SMBs to jump. The standalone systems and manual processes found in many of these companies simply cannot keep up with the strict regulations surrounding every step of the manufacturing processes – from procurement, through recipe management and reporting. In response, SMBs spend an inordinate amount of time and labor dollars on repetitive data entry across the business.
Larger pharmaceutical companies with greater financial resources are taking advantage of the latest technology to help address these issues. But tighter budgets and resources have kept many SMBs from realizing the tremendous business benefits this technology provides.
Now, these SMBs can leverage the IBM BioPharmaceutical Solution for mySAP All-in-One, a fixed-price and fixed-timeline solution that is pre-configured to accelerate deployment and improve time-to-benefit. In fact, the solution can be implemented in as few as 12 weeks.
This shortened implementation timeframe is intended to minimize business disruption, lessen risks and deliver a predictable return on investment. A single integrated platform is designed to help SMBs get products to market sooner and establish themselves as globally enabled enterprises.
“The mySAP All-in-One Solution leverages IBM’s 10+ years of experience in implementing SAP solutions in the world’s largest pharmaceutical and biotech companies,” says Alex Deaton, a partner in IBM’s Business Consulting Services group. “We’ve combined that experience with SAP’s leading practices for the industry to deliver a cost-effective, pre-packaged solution that works for SMBs just like it works for industry giants.”
Qualified by SAP in May 2004, the IBM BioPharmaceutical Solution for mySAP All-in-One is part of the industry’s largest mySAP All-in-One solutions portfolio. IBM already offers 55 vertical and horizontal solutions to select geographic regions around the world. Further, IBM has partnered with SAP to deliver SMB solutions for nearly 15 years.
Integrated for action
A midsize business cannot spend scarce resources on clerical activities or repetitive data entry. Instead, companies need to be free to focus on researching and developing new products and devices and analyzing the business.
The integrated mySAP All-in-One solution replaces these inefficient processes to decrease costs, increase productivity and improve product lifecycle management. Leveraging industry-specific leading practices and a pre-configured platform, the solution is designed to optimize, integrate and manage virtually every business process – from materials and warehouse management and production planning to sales, distribution and finance.
With the mySAP All-in-One solution, there is no need for multiple people to maintain the same customer, vendor or product information. Data is entered only once into a master record which is immediately available for any department to see, use or analyze.
SMBs are also anxious to integrate data with suppliers and partners. This collaboration is a benefit that large companies have long enjoyed through electronic data interchange (EDI). The mySAP All-in-One solution provides SMBs with EDI tools to facilitate the exchange of information about schedules, purchases or shipments to quickly optimize the entire supply chain network.
“SMBs can now have integrated data and business processes across the value chain while decreasing time-to-market and managing compliant systems,” says Deaton. “With integrated information, SMBs have a seamless view of the business. They can make informed decisions around upcoming procurement and inventory needs to meet demands and have immediate insight into where to focus efforts for the best business results.”
The FDA has rigorous regulatory mandates in place to protect consumers. Additional compliance regulations present a challenge for SMBs, which are subject to the same standards as large companies. Preparing operations for compliance can be costly. But the penalties for non-compliance can be harsh, including orders to cease production entirely. “Since millions of people may rely on that product, non-compliance can be devastating not only for the company, but also for many patients,” explains Deaton.
The integrated mySAP All-in-One solution from IBM makes tracking and managing data for FDA requirements much easier and more cost-effective. Industry-specific reporting capabilities and standard SAP audit trail and electronic signature functionality help biopharmaceutical companies address the requirements outlined in 21 CFR Part 11.
Even more importantly, the solution helps SMBs respond to the FDA’s current Good Manufacturing Practice (cGMP) for the 21st Century initiative. Announced in 2002, this initiative is aimed at making sure that regulatory review, compliance and inspection policies are based on state-of-the-art pharmaceutical science to ensure the quality of drug products in the US.
Ready for high growth
With full product lifecycle management, the IBM BioPharmaceutical Solution helps SMBs prepare for the rapid growth that occurs once they secure FDA approval. Rapid growth is a challenge for any SMB, but growth is especially hard for start-up companies without efficient systems and processes in place to support data-intensive activities, including finalizing and documenting bills of materials and defining standard operating procedures and routings for each product.
“Speed is critical to bringing the product to market and obtaining FDA approvals,” says Deaton. “The All-in-One solution helps ensure that all the activities supporting the product lifecycle run as efficiently as possible, so companies can ramp up production immediately.”
As the business grows, the flexible solution scales to support strategic objectives and shifts in market conditions. Leveraging open Linux technology, it provides this scalability at a reduced cost. The solution is also available on the IBM DB2 Universal Database, IBM eServer and TotalStorage platforms, as well as other commercial platforms.
A pre-packaged platform and configuration template built into the solution, along with inherent SAP leading practices, are designed to speed implementation. IBM Business Consulting Services works with each customer to deliver the pre-configured solution. A typical implementation can be completed within a 12-20 week timeframe, depending upon customer requirements.
This implementation timeframe can include a “quick scan” workshop where consultants validate the customer fit for the IBM mySAP All-in-One solution. Biopharmaceutical solution consultants then take part in all aspects of the blueprinting, realization and implementation phases, including conversion of master data, training and testing. Consultants even return after implementation to determine which expected benefits are being realized or if additional optimization would help customers further leverage the solution.
Deaton says a key differentiator for IBM solutions on the biopharmaceutical market is the continual re-evaluation of the mySAP All-in-One solution to ensure it is addressing key customer business issues. For example, when the Drug Enforcement Agency introduced regulations around the tracking of controlled drugs, IBM added functionality to support this requirement.
“We’re constantly adding functionality to new releases, based on feedback we receive from live client implementations,” he says. “So we’re continually improving the solution to increase customer benefits.”
For SMBs, those benefits are many. “mySAP All-in-One enables SMBs to adopt progressive business practices that position them for profitability and growth,” Deaton continues. “More importantly, it frees biopharmaceutical companies to do what they do best – discovery and development.”
For more about the IBM BioPharmaceutical solution for mySAP All-in-One, visit: http://www.sap.com/solutions/smb/allinone/prepackagedsolutions/ibmbiopharm.aspx.