The Record - Issue 9: Summer 2018

122 www. t e c h n o l o g y r e c o r d . c om I nvented as the ‘language’ to give instructions to computers, software has long been the back- bone of every successful organisation. Initially companies invested in software to automate repetitive manual processes and thereby speed up, and improve the quality of, their operations. To differentiate themselves from the competi- tion, some companies contracted IT vendors to develop software solutions that were custom- ised to their specific needs. Over time, these IT vendors identified patterns in the software requirements for each industry and began to create customer-independent (or standardised) commercial-off-the-shelf (COTS) solutions. Developed and maintained by one vendor, COTS software offers standard features that have been extensively tested for general use by any company, which means it can be quickly scaled and validated when it is implemented by a business. COTS solutions can be more easily updated and revalidated whenever a new ver- sion of the software they’re built on is upgraded, which means that companies face significantly lower costs and fewer compliance issues. COTS solutions designed for a specific market have the added benefit that their standard features can be configured to meet a company’s specific needs without extensive programming. For example, one organisation could configure a standard COTS solution to offer one step item approval process, while another could configure it to provide a more complex approval process by involving different departments. The first COTS software was designed to address basic business needs, such as sending written communications electronically and performing calculations. These COTS solu- tions included operating systems, integrated development environments and individual productivity applications (such as spreadsheets and word processors). Next, IT vendors created COTS software that automated industrial busi- ness processes, such as financial management, accounting, and sales and purchasing. These solutions saved companies time, increased quality and user satisfaction, and generated business performance data. Financial manage- ment systems evolved into enterprise resource planning (ERP) systems, which can be inte- grated with other external systems and applica- tions to provide all the functionality a company needs to operate successfully. The International Society of Pharmaceutical Engineers’ Good Automated Manufacturing Practices (GAMP) subcommittee adopted the COTS concept to develop and implement soft- ware solutions that complied with the pharma- ceutical industry’s Good Manufacturing Practice (GMP) guidelines. The guidelines provided in GAMP 5 are used to classify software into var- ious categories, including Category 4 configur- able COTS solutions that can be parametrised to meet a company’s needs without coding. Today, there are multiple GAMP 5 Category 4 configurable COTS solutions that can be implemented by pharmaceutical companies, but there’s not yet an end-to-end solution that Taking a COTS approach Commercial-off-the-shelf software offers multiple benefits to pharmaceutical companies who want to cost-effectively manage their production processes, while remaining compliant with industry regulations ANDR E A RUOS I : AX FOR PHARMA V I EWPO I NT “AX for Pharma Dynamics 365 is the only COTS solution that covers all the needs of pharmaceutical manufacturers”