Operational challenges for the Pharma Industry

For most Pharmaceutical businesses it is a highly complex problem, particularly when near real time views are of paramount importance and data creation is exponential.

If you are trying to collate and make sense of

A&E (Alarms and Events) data from the shop floor – the problems that are anticipated.

They are probably using a Historian application which builds a historical database of huge amounts of Alarms and Events Data from a wide array of sensors, devices, applications etc. This requires the creation of a huge schema that allows the database to hold and manage disparate data types in a single warehouse style application. The data is then loaded, batch wise, and the resulting dataset is usually analysed using a complex specialist tool like Hadoop, or more generically in large spreadsheets.  These are always backwards looking.

Data feeds from myriad devices and processes – the source of data that might be able to predict problems before they happen

Modern manufacturing plants are full of things that generate data all the time, not just when A&E have been triggered.  That data is often ignored unless an A&E occurs.  There is value there, but it is difficult to identify unless it can be analysed in accurately collated time series.

How your assets are performing and being used, their patch status and vulnerabilities – the metadata about the assets rather than what they are doing.

Factories are also full of computers, and computers are vulnerable.  It is essential that they are kept patched up to date, with regard to their operating systems, and malware protection particularly It is common to find companies that have invested in Governance Risk and Compliance (GRC) software for this purpose, but in the deluge of information their reports are viewed irregularly and always in arrears.

How those assets are being calibrated, maintained and serviced – more metadata, this time about the way the assets are maintained etc.

The Pharmaceutical business is complicated by the very high levels of compliance, sometimes known as GMP Maintenance and Calibration, your processes and products must balance GMP compliance with maximum productivity.

Many of the factory floor devices must be calibrated frequently to ensure accuracy, and of course maintained and serviced to make certain that they are functioning correctly. Accordingly, they invest in tools to allow them to record and report on these activities.  These tools generate data that needs to be viewed and understood to be valuable.

The performance of the networks and systems that connect them all – the network info rather than the devices on the network.

More reports, more data. The complexities of this environment are such that some technical expertise is required to interpret them. Typically, the Exec team get sight of these interpretations, usually some time after the events that are being monitored have occurred.

The extent to which Standard Operating Procedures (SOPs) are being followed. The rules that have to be followed by everyone in the organisation.

SOPs are written to comply with legislation.  Failure to comply can lead to prosecution and multi-million-dollar value fines as well as reputational damage.  Large amounts of organisational time are devoted to monitoring processes for compliance, collating the data in reports, publishing them to a defined audience who then devote time to reviewing them.

Keeping up with this extreme amount of data is hard.  Keeping up with it in real time is very difficult indeed unless you have the right tools, properly configured.

What is needed is the ability to

• Recommend a toolset, often reusing something that is already licensed/subscribed for by the organisation and configure it to
• Ingest/integrate vast amounts of data streaming from the myriad of devices
• Place them accurately as events on a timeline
• Interrogate that timeline, identifying cross correlations between different devices and sources on a single device
• Display the outcomes of these processes on a convenient, easy to interpret near real time dashboard
• A toolset and process that does really deliver an Enterprise view of compliance risks is absolutely critical

apto has recently helped a leading pharma company in achieving the enterprise view, using Splunk.  Splunk has helped many pharma companies and there is some useful further reading here Why not contact us below and see how we can help.