The pharmaceutical industry is mired in a period ofunprecedented change and uncertainty as many top-sellingdrugs are coming off patent while pipelines are rather limited inmany top companies. These trends are leading companies tolook for efficiencies to reduce costs, via mergers and acquisitions,increased reliance on outsourced organizations like CROs, andnew ways to partner with third parties for development efforts.Companies are particularly interested in ways to bring newproducts to market faster and at a lower cost while improvingquality – whereby the concept of Quality by Design (QbD) isreally helping to shape the ‘new’ development paradigms.Simultaneously, companies are looking to reduce costs byrationalizing Information Technology spend. Rather than settlefor sub-optimal processes and systems, organizations shouldlearn how best-in-class companies are utilizing IT systems for theirintended use to save the organization money while increasingcompliance at the same time.The Situation:Time and time again pharmaceutical organizations follow afamiliar path when evaluating their software landscape. EveryGMP organization has debated the roles of ERP and EQMSsystems, with most ultimately deciding that supply chain belongsin ERP and quality processes belong in EQMS, yet now a newtechnology, Product Lifecycle Management (PLM), is starting tocrop up in the same conversation. Where did PLM come from?What role does it play in regulated industries? Can it really replaceexisting systems or is it an additional technology to support thepharmaceutical industry? These questions are asked in manypharmaceutical companies but few are equipped to answer.The value proposition of PLM is compelling, bringing newproducts to market faster, and aligns directly with QbDstrategies. Senior Management, led by the R&D implications,may have even bought into the concept and is aligned behindthe methodologies. Now that the money has been spent, IT islooking for ways to ‘leverage the investment’ based on the visionof PLM.At this point the quality organization starts facing the familiarquestions “why do you need EQMS when PLM can do the samething? Why do we need to maintain multiple systems when fewerwill do the same job?” Much like with ERP, the situation becomesclearer when the voice of experience, not software vendors, istaken into account when evaluating strategies to deploy systemsthat meet the organizations needs at the lowest Total Cost ofOwnership.Figure 1: Typical EQMS DiagramEQMS Vision:Although most companies start with one qualityprocess, forward thinking organizations see the value ofintegrated systems and ultimately build full EQMS.
Introduction to PLM:PLM is a technology that has been around for 20+ years, howeveronly in limited capacity in pharmaceuticals. While ERP began as atechnology to streamline operations and supply chains and EQMSwas designed to help companies meet the quality obligations ofhighly regulated products, PLM was designed to help R&D bring newproducts to market faster by introducing the concept of ‘reusableparts’ in the automotive industry. Clearly, it’s easier to make the nextgeneration of a product, including validation and documentationactivities, when you reuse components from an existing product andPLM provides technology that enables such reuse.Reusable parts are a great concept, but in reality it is primarily adiscrete-manufacturing concept. In FDA-regulated industries, PLMwas historically used in some medical device companies but is justnow starting to show up in pharmaceuticals, in particular with theintroduction of QbD concepts. PLM is prevalent, however, in non-FDA-regulated industries such as automotives, aerospace, and oil andgas– essentially anything that uses Computer Aided Drafting (CAD) todesign their products. FDA compliance, as well as global regulations,just isn’t a cornerstone of PLM systems like they are for EQMS.The vision for PLM in pharmaceutical companies makes sense: Asingle system to manage all design information from initial conceptto the different stages of development and through end-of-life, whileapplying appropriate controls along the way. Drug portfolio andcommon technical documents (CTD) information is managed andmaintained in the system and due to the robust permission model,partners can access data to collaborate on new products or clinicaltrial results to introduce products faster than ever before.Now that PLM vendors are opening the door into the pharmaceuticalmarket via R&D, they are attempting to build a case to performEQMS functions as well because after all, a central premise of QbD isbuilding quality into the product initially. This has long been a tenetin other PLM industries like automotive, aerospace, and medicaldevice, and certainly makes sense to apply to pharmaceuticals.Although quality processes seem like a logical extension of a PLMsystem, the reality is that quality functions in PLM are centeredaround product changes, called engineering change orders intraditional PLM lingo. Manufacturing organizations simply can’tfunction if design changes aren’t propagated effectively across theorganization. For example, can you imagine purchasing a new AppleiPhone 5 that came in an Apple iPhone 4 case?Over time PLM vendors looked upstream in the process flow andrealized that many changes come from CAPAs so now PLM vendorsare attempting to expand footprint there as well. This makes senseon the surface, but where do CAPAs come from? Primarily deviationsand complaints, as well as audit deficiencies. Logically, PLM also aimsto capture these to show the inputs to CAPA as well – which is thespace on which EQMS has been focused for years.It’s helpful to compare and contrast technologies and how theyhave evolved:Figure 2: Quality Systems TechnologiesEach is geared towards a specific audience and has features/functions that appeal to that community as well. Below are summaries of each technology:ERP PLM EQMSPrimary Audience Operations, Supply Chain R&D, New ProductDevelopmentManufacturing Quality, Auditors,Complaint Handling UnitsProcessesInventory Management, HoldStatus, Bill of MaterialQuality by Design (QbD),Document Management,Change Order ProcessingCAPA, Nonconformances, Audit,Complaints, Holistic ChangeManagementCore competency Inventory Management, Costing Revision Control/DocManagementWorkflow Management,Closed-loop Processes,ConfigurabilityKey Value Proposition Enable supply chain efficiencies Develop new products faster Streamline processes and enablecontinuous improvement in bothprocesses and productsFlexibility Low Medium HighCost $$$ $$ $Time to Value High Med Low