Current challenges and trends
Lack of information. Historically, the major drivers for visibility and analytics in the life-sciences industry have been process understanding
and control, as well as corrective-action programs to address adverse events, recalls, and other unexpected problems after
they occur. The value of visibility was often measured by "how quickly can you get the data to fix the problem." Historical
data, although valuable when "fixing problems," did not support the proactive and predictive approaches needed to support
today's agile and fluid pharmaceutical manufacturing environments. Having postfacto visibility alone is not a viable option.
Figure 3: Brand-owner visibility into external suppliers’, distributors’, and shippers’ practices.
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When asked, "What is your visibility into your external suppliers', distributors,' or shippers' practices?" 77% of industry
executives responding to the Axendia survey stated that the primary method used is a periodic audit (see Figure 3). Only 25%
of respondents said they share common practices and information with suppliers, and only 3% have access to suppliers' data
in real-time. This trend is a bit higher with contract manufacturers, with 51% of executives reporting that they share common
practices and information. The downside of a periodic audit is that it only demonstrates what's happening at a given facility
at one time, and often, it only takes place once every year or two. After performing an audit, companies often do not receive
new data from their suppliers or contract providers until they get a batch of product along with some form of a quality certificate
or certificate of analysis.
Figure 4: Usefullness and timeliness of currently used industry systems for retrieving data from multiple locations and sites.
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Lack of control. When asked about their ability to gain global visibility into the supply chain (i.e., across multiple locations), only 19%
of survey respondents said they can get data in real time. Another 15% said that obtaining real-time information was not possible,
and 66% said they can get the information but then have to manually aggregate the data (see Figure 4). It becomes even more
difficult to maintain quality control over products when your company is not the one producing or manufacturing the active
pharmaceutical ingredient or component, as is the case when sourcing/outsourcing. With so many processes and raw materials
manufactured outside companies' facilities, however, it is crucial to maintain contact with all parties in the product's network.
When asked, "How useful is your current supply-chain process or system for managing your business?" only 21% responded that
their current systems or processes are useful. Thirteen percent said their current systems do not provide help in managing
their supply chain, and 57% reported that obtaining the information needed to run the business is slow, although their current
systems are helpful.
As expected, the vast majority (96%) of large organizations (those with revenues more than $1 billion) responding to the Axendia
survey say they have implemented systems or processes to manage their supply chains. However, industry executives of those
larger companies have lower satisfaction levels with their systems; only 17% ranked their systems as useful.
Figure 5: Systems used by industry to support global supply-chain visibility. (Note: Homegrown includes spreadhseets, databases,
etc. ERP is enterprise resource planning, QMS is quality management system, CRM is customer relationship management, LIMS
is laboratory information management system, SCM is supply-chain management, ECM is electronic content management, MES is
manufacturing execution systems, and PLM is product life-cycle management.)
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Most companies said they use enterprise resource planning (ERP, 65%) and quality management systems (QMS, 55%) to gain visibility
into their supply chains (see Figure 5). Thirty-one percent still use homegrown systems, such as spreadsheets, custom systems,
and databases, and 27% still rely on paper.
When asked, "What information can you currently track related to key/critical components of your product?" the vast majority
of executives said they could track manufacturing location (84%) and genealogy (73%) such as the raw material, ingredient,
or component. On the other hand, less than 50% said they could track critical information for key components, including: transaction
history, chain of custody, record of ownership, environmental storage conditions (i.e., when critical to for product safety/efficacy),
or ePedigree.
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