The Journal of Industry and Technology

Industrial Analytical Instrumentation

Euro Technology

Serving industry for over 36 years
Three leading magazines for key executives,  engineers, universities,
manufacturers, laboratory technicians, scientists, and research establishments

Life sciences and clinical instrumentation

Smarter steps to compliance: The future of
regulatory compliance in the pharmaceutical industry

The pharmaceutical industry today operates in one of the world's most heavily regulated environments. Over the past few years, the industry has experienced significant regulatory change and looking to the future, the strict nature of the industry doesn't appear to be slacking.

The repercussions of failing to comply with industry standards can be detrimental for pharmaceutical manufacturers. It's no secret that the integrity and reputation of pharmaceutical brands is integral to their success. As a result, even the smallest failure can be irreversibly damaging.

With industry standards surrounding crucial elements like product integrity, energy efficiency, health and safety and product testing, there is more pressure than ever to ensure manufacturers begin to take steps towards compliance. In this elaborate regulations landscape, how do manufacturers ensure production operates in an efficient and effective way?

Validation-friendly technology
Digitization of processes and the emergence of Industrial Internet of Things (IIoT) has transformed the entire manufacturing industry. However, for pharmaceutical manufacturers, the benefits of IIoT have far surpassed an increase in automated productivity.

The introduction of smart devices enables real-time data reporting to central control systems. Naturally reducing manual intervention and minimising adverse events during production. Paired with validation friendly software, an IIoT enabled factory provides live monitoring of regulatory reporting, potentially reducing the validation efforts many manufacturers face with a risk-based approach. This can greatly help to maximise production agility, allowing manufactures to respond to change and ultimately increase profitably.

For example, with batch control being a key step of the validation process, the combination of a smart factory and intelligent SCADA software couldn't be more valuable. Automatically generating a trail of reliable audits, electronic signatures and real-time reporting, complicated pharmaceutical standards like FDA 21 CFR Part 11 are not so difficult to obtain.

The cloud and compliance
As manufacturers embrace IIoT, migrating to the cloud is the obvious solution to house and manage the growing expanse of production data. However, the cloud does more than just collect and store data, it allows manufacturers to gain actionable insights, directly from it.

Predictive analysis, for example, produces an intelligent forecast of when and where industrial equipment is most likely to fail. Using this data, contingency plans can be made to ensure, regardless of equipment failure, pharmaceutical production will continue to meet regulatory standards. 

In addition, cloud computing enables simplified regulatory submissions. Using data stored in the cloud, manufacturers can directly feed digitised production information to regulatory bodies. This feature can be particularly helpful speeding up the lengthy process of clinical trials as well as post drug launch. 
With the ever increasing risks concerning drug counterfeiting, efficiency challenges, adaptations to modern day agile processes and the industry-wide efforts to implement serialisation, it will be interesting to witness how IIoT can continue to solve these challenges moving forward. 

Getting the green light
Over the past decade, the global focus on environmental sustainability has been hard to ignore. In industry, initiatives such as the European Union's Energy Savings Opportunity Scheme (ESOS) and the voluntary certification ISO 50001, have put pressure on manufacturers to jump on the efficiency bandwagon. Using the same IIoT and smart software combination, organisations can gather comprehensive data from the entire factory and subsequently meet these efficiency requirements.

COPA-DATA in profile
COPA-DATA is the technological leader for ergonomic and highly dynamic process solutions. The company, founded in 1987, develops the software zenon for HMI/SCADA, Dynamic Production Reporting and integrated PLC systems at its headquarters in Austria. zenon is sold through its own offices in Europe, North America and Asia, as well as partners and distributors throughout the world. Customers benefit from local contact persons and local support thanks to a decentralized corporate structure. As an independent company, COPA-DATA can act quickly and flexibly, continues to set new standards in functionality and ease of use and leads the market trends. Over 80,000 installed systems in more than 50 countries provide companies in the Food & Beverage, Energy & Infrastructure, Automotive and Pharmaceutical sectors with new scope for efficient automation.

About zenon
zenon is COPA-DATA`s highly versatile product family for industry-specific ergonomic process solutions: from sensors through to ERP. It consists of zenon Analyzer, zenon Supervisor, zenon Operator and zenon Logic. zenon Analyzer provides templates to create tailor-made reports (e.g. on consumption, downtimes, KPIs) based on data from IT and automation. zenon Supervisor, an independent SCADA system, allows comprehensive process monitoring and control of redundant systems, even in complex networks and with secure remote access. zenon Operator guarantees, as an HMI system, safe control of machines and simple, intuitive operation - including Multi-Touch. zenon Logic, which is an integrated IEC 61131-3-based PLC system, allows optimum process control and logical data processing. As a platform-independent portfolio for process solutions, the zenon Product Family integrates smoothly into existing automation and IT environments and provides set-up wizards and templates to enable easy configuration and simple migration from other systems. The principle of "setting parameters instead of programming" is a characteristic feature of the zenon Product Family.

For further information, view website: www.copadata.com 
Refer to page 906 

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