Sparta Systems.pdf - Pharma
One interesting aspect of these technologies is that while each handles its core competency well, each has also tried to expand into nontraditionalfunctionalities in response to organizations asking them to ‘do more with less’. This results in simple functionality that might meetthe needs of certain business cases, and maybe even look attractive during software demonstrations. However, it will fall short when eventhe slightest complications arise – such as multiple product lines, discrete vs. process manufacturing and supporting multiple changingregulations. ERP is the most common system people think about in this scenario, as these systems often represent a company’s mostsignificant software investment and therefore are very attractive to ‘leverage’, however the same challenges exist when attempting to leveragePLM for EQMS functions.A good test of any vendor is to ask for references – which can prove challenging for any vendor that’s ‘new’ to a space and should definitely beleveraged on something as critical as EQMS. Also consider asking your quality and regulatory colleagues to describe a key quality process, suchas deviations, and then ask vendors to share their vision of the same process. Undoubtedly, EQMS vendors will more closely express what endusersdescribe, in particular the relationships of OOS/OOT and EBR systems, while PLM vendors will dilute most of the process into high-levelbuckets and focus more on the resulting change request/engineering change order.Figure 3: Deviation Handling ProcessLet’s go back to figure 2 : If PLM’s core competencies developed in the past 15 years are revision control and reusable parts, while EQMS’s corecompetencies developed in the past 15 years are workflow management and closed-loop processes, what’s the likelihood that either couldquickly and fully develop the functionality that took the other more than a decade to develop and refine? Clearly not likely. Pharmaceuticalmanufacturers must ask the question, then, whether they really want to be a software vendor’s “test case” for a critical component of thebusiness.
So what is the impact of not effectively managing quality?• Increased regulatory risk: CAPA continues to be the number one item cited by regulatory bodies, while new regulations are anafterthought, at best, for PLM and ERP vendors.• Increased TCO: Changing processes in systems costs money; validation costs even more. ERP and PLM simply cost more toimplement and change than EQMS.• Increased time-to-value: Implementing any system takes time and stretching a solution’s functionality beyond its limits takesadditional resources before any business benefits are realized – if at all.• Hidden costs: Due to a) customization and b) force-fitting an individual business into a templated model.• Failed projects: What happens after years of ‘trying’ to go live with the wrong system? Turn it off and try again, all at unnecessary costand risk to the business.• Inability to evolve as the business and regulations change: A ‘new’ IT system becomes a liability in maintaining a compliant stateand could stop the business from acquiring new companies that follow different requirements, such as combination products,pharmaceuticals or biologics.Conclusion:As companies strive to achieve the optimal mix of IT systems to optimize their business, it’s important to recognize the strengths andweaknesses of all potential systems to ensure what’s being leveraged will truly bring the business forward and reduce TCO.In today’s competitive environment, companies that choose to ‘leverage’ ERP or PLM to handle EQMS capabilities are really electingto fall behind the competition by placing themselves at greater regulatory risk. They also are likely to spend more money than if theychose the path of implementing a best-of-breed EQMS system and integrating it into their system landscape.Sparta Systems’ global quality management solutions enable high-value organizations to safely andefficiently deliver products and services to market. Its TrackWise® Enterprise Quality Management Software,a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatoryaffairs professionals to manage compliance, reduce risk and improve safety across the global enterprise.Headquartered in New Jersey and with locations across Europe and Asia, Sparta Systems maintains anextensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturingand consumer products markets.www.spartasystems.com | http://blog.spartasystems.comGlobal Headquarters2000 Waterview DriveHamilton, NJ 08691(888) 261-5948(732) firstname.lastname@example.orgEuropean OfficesBerlin | London | Tel Aviv | Viennaeuropeemail@example.comAsia Pacific OfficesHong Kongapacfirstname.lastname@example.org