(Wheaton, Illinois) May 30, 2007 — Each day, Life Sciences organizations are inundated with a large amount of information to manage related to their customer-facing, manufacturing and supply chain processes. Specific records are required to log every procedure and step involved in customer orders, the procurement of materials and the manufacturing and distribution of each product produced. Previously, all information was captured in unstructured files, such as spreadsheets and word processing documents, and then printed and manually acted upon as paper forms.

Often, these paper forms are required to be tracked and manually transported along as the business process is performed to record every verification and approval involved in each activity and step. The use of paper-based processing consumes an excessive amount of resources and time, and introduces other inefficiencies into the organization.

Why go electronic?

With electronic systems supporting key operational processes, activities and steps happen faster, and the work is able to be acted upon by multiple authorized users. As an example, if a qualified supplier’s information requires an authorized signer before the record can be changed, it would involve physically finding the authorized signers’ list, physically finding an available authorized signer, getting the document signed off on, and filing the original and copies into physical locations. The same process happening in electronic systems could have the system display the authorized signers for the change, notify the signers electronically (regardless of their physical location), have the authorized signer review and approve the change online, and have the system catalogue the change electronically, including all of the prerequisite audit trail information. The electronic process is faster, more efficient, more controlled and more secure. It saves time during the process and will also save time in the future if the history of the process is reviewed.

Advantages of electronic processing

For many Life Sciences companies, the move to electronic records is centrally about efficiency. With advances in technology, portions of these cumbersome paper-based processes have become obsolete. Electronic processing offers immediate access to data from multiple sources and multiple locations. At a touch of a button, users may access a vast amount of information that may be used to improve planning, optimize decision-making, and lower costs. For other Life Sciences companies, it is about moving to tighter controls. Electronic records properly implemented will vastly reduce the risk of non-conformance over a paper-based approach. But perhaps the most significant advantage that Life Sciences companies obtain is improvements in their customers’ experience. Because processes can be performed faster, products can be delivered faster with the same or higher level of quality and control. Services can be delivered real-time when all of the information is at the search bar, versus buried in some file cabinets. New web services and search components enable information to be consumed in the form and device mode that is most easily adopted by companies’ team members and customers. But while the benefits of electronic processing far outweigh the old, manual paper based approach, it is not without its own challenge.

What is the risk?

Though ultimately far superior, the transition to and maintenance of electronic business systems has been complicated by government regulations specifying criteria necessary for electronic records to be accepted. In 1997 government regulations took effect, with enforcement beginning in 2000, that defined the parameters by which Life Sciences companies can author, approve, store and distribute such records electronically.

Part 11 of the Federal Drug Administration’s Title 21 of the Code of Federal Regulations (known as FDA 21 CFR Part 11) was specifically designed to ensure government compliance for pharmaceutical and other Life Sciences organizations using electronic records. Similarly, publically traded organizations using electronic records must comply with Sarbanes-Oxley (SOX) regulations. Depending upon the structure of the business, some Life Sciences companies must comply with both regulations. Non-compliance could lead to expensive downtime, compromised product quality, regulatory fines and, in the case of fraud, possibly even prison sentences.

General industry business software does not meet the needs of Life Sciences companies looking to move to electronic processing. They lack the architecture for tracking and recreating change history according to the regulations and the way auditors will want to see the electronic information. They also lack the preventative controls that must exist inside the software to enforce business process rules and support authorized signers. In addition, consulting services firms often lack the knowledge and experience required to deploy business systems in a validated manner in accordance with FDA regulations. When the stakes are high, business systems must be in place that mitigate risk points and ensure proper processing of critical data. Consulting firms must also be able to support the deployment process necessary for validated systems.

It is a challenge to determine the optimal balance between documentation, organizational productivity, costs and procedural risk. Many organizations lack the ability to effectively integrate mandatory government compliance in a feasible manner because of lack of resources, cost, inexperience or all of these.

How to minimize risk in electronic processing

For Life Sciences companies who meet FDA 21 CFR Part 11 regulations, electronic records and signatures can legally replace their traditional paper counterparts. Although Part 11 does not actually require companies to adopt electronic processes, it does regulate those who do. For companies with high risk, whose products can cause life-or-death situations, quality compliance is an essential government requirement. It is also essential for the production of a top-quality product. To pull everything together swiftly and accurately, specific compliance expertise is essential.

About Merit Solutions Life Sciences Software and Services

For Life Sciences organizations who are making the move to electronic business systems, Merit Solutions offers pre-built software that meets the specific needs of the Life Sciences industry. Merit Solutions’ Life Sciences software includes the architecture necessary to control risk processes, comply with FDA and other regulations, and meet the common business process needs of Life Sciences companies. Merit Solutions Life Sciences software is built within Microsoft Dynamics business systems, the global leader in business applications software for growth companies. As a result, Life Sciences companies are able to get the dual benefit of innovation in Microsoft business software along with the benefit of specialization from the Merit Solutions software components. In addition, Merit Solutions’ experienced Consulting Services team offers expertise to effectively deploy business systems that comply with federal regulations.

Merit Solutions offers a proven, repeatable and predictable consulting methodology that ensures rapid deployment of system integration. Merit Solutions’ implementation methodology is comprised of predesigned FDA validation templates and a process that is easily customizable for individual environments. When additional customization is desired, Merit Solutions Consulting Services works along with the Merit Solutions Software Development Services team to automate even the most complex, unique situations.

Merit Solutions is a leading IT consultancy and software development firm specializing in the Microsoft Dynamics technologies. Directly and through a channel of partners worldwide, Merit Solutions helps clients plan their technology investments, design solutions, and implement competitive business processes through innovative software products, software development services and business consulting services. From locations near Chicago, near San Francisco and in Europe, Merit Solutions serves general industries, and specializes in Manufacturing and Life Sciences.

For more information about Merit Solutions software and services, contact:

Tim Strudeman at tstrudeman@meritsolutions.com or 630-614-7133, x227 and visit our website at www.meritsolutions.com

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Please address editorial inquiries to Jan Coopman at
jcoopman@meritsolutions.com or 630-614-7133, x232.