admin

Most common data integrity violations in life science manufacturing and how to avoid them

Data integrity is defined as the extent to which all data are complete, consistent, and accurate throughout the data lifecycle. It includes all original records and true copies, including source (raw) data, metadata and all subsequent transformations and reports of these data. The requirements for data include that they are attributable, legible, contemporaneous, original and accurate (ALCOA).

Data integrity is not a new topic – it has been around for more than two decades, with FDA warning letters citing lack of control with computerized systems already in early 2000s. But why is it suddenly becoming such a hot focus area for the regulators?

Technological progress has enabled introduction of numerous IT systems and solutions to support manufacturing processes. On one hand, this means that increasing amounts of data are being generated, which can be used for process insights as well as quality and efficiency purposes. On the other, expectations from the regulators regarding monitoring and reporting tools and procedures have also increased. Thus, a positive loop was created of higher expectations and additional (required) progress in manufacturing IT solutions for data gathering, aggregation and processing.

Advisory company Deloitte analyzed FDA warning letters and identified that majority of them contain elements of data integrity. Moreover, the trend has been worsening in recent years. Four most common data-related infractions were:

1. Data not fully and accurately documented.
2. Critical deviations not investigated.
3. Lack of adequate access controls. 
4. Data not recorded contemporaneously.

Moreover, a lot of data is siloed in production systems and machines, without any connection to manufacturing IT systems, and is thus dispersed and unmanageable in “Data Integrity” principles. Furthermore, such data is inaccessible for reporting and analytics purposes. It gets even worse – as per market research company Vanson Bourne, as a result of disconnected data, workers are on average also spending more time searching for, acquiring, entering, or moving data (8 hours per week) than they do making decisions on that data (7 hours per week)!

That is why more and more life science companies are actively working on breaking down the data-isolating silos in their manufacturing not only to solve Data Integrity and regulatory compliance issues, but also to exploit the gathered data to the fullest extent for process insights, reporting and analytics.

Solution lies in a central manufacturing data management platform

To connect all the manufacturing sources of GMP-relevant data, from existing data historians to dispersed data storages on the machines, life science companies are opting more and more for the introduction of a central manufacturing data management platform. This way, they are enabling proper “Data Integrity friendly” data management as well as access to real-time (contextualized) production data for reporting and analytics.

Contemporary central data management platform must provide the following functionalities:

• Connectivity to various data storage historians and databases as well as ability to provide automatic data acquisition from manufacturing devices / systems
• Central data management and contextualization
• Ability to enter manual inputs (where automatic acquisition is not possible)
• High user security and full audit trail
• Seamless exposure of data to reporting and analytics systems (including 3rd party)

With such a platform, all ALCOA requirements can be met and full data integrity achieved.

MePIS PDM – State-of-the-art platform for production data management, reports and process analytics

MePIS PDM is an advanced process data management platform that enables you to gather, organize and manage production data. It is the cornerstone for the creation of production reports, comprehensive production analyses and data integrity in life science manufacturing.

On the one hand, MePIS PDM enables you to create tailored production reports with custom report approval workflows and also has an embedded audit trail, contributing to higher levels of GMP and regulatory compliance.

On the other hand, it provides a basis for production transparency and process analytics. MePIS PDM ensures a real-time overview of equipment status and quicker reaction times in production. It also allows you to compare time-series data with events and compare batches to identify the “golden batch”.

MePIS PDM can seamlessly connect to production systems and machines on the one hand, and production IT systems (MES) on the other.

Key MePIS PDM functionalities:

Achieve effective reporting, process visibility and stressless audits

MePIS PDM users report the following benefits:

• Improved data integrity, GMP and regulatory compliance
• Seamless and fast report preparation, tailored to production needs
• Improved transparency of production processes and faster response to events in production
• Fewer deviations and operator mistakes
• Analysis of time-series data and events, ability to compare batches and identify the “golden batch”
• Systematic development of process and quality improvements
• Fast data export and access for further analysis and data mining

For more information, please contact sasa.sokolic@metronik.si or visit: https://mepis.eu/solutions/mepis-pdm/

by admin

Metronik at the National Manufacturing & Supply Chain Conference and Exhibition in Dublin

Metronik is participating in the international fair "National Manufacturing & Supply Chain Conference and Exhibition," held on 25 and 26 May 2022 in Dublin, Ireland.

The two-day event, intended to manufacturing companies and solution providers for various industries, is divided into several content areas such as Industry 4.0, 3D printing, digitalization of production, smart factories, lean manufacturing, robotics and automation, sustainable strategies, maintenance and management of production equipment and others.

Metronik will present the complete set of MePIS solutions for the comprehensive digitalization in the pharmaceutical production.

At the exhibition, Metronik will represent "MIT” (Metronik, Inomatika, Trac) partnership – a partnership of Slovenian companies, which joined forces for business expansion to the Irish market of automation and digitization solutions for pharmaceutical production. The partnership was endorsed in the public tender "Promoting partnerships for more effective performance in export markets 2020-2022".

The operation is co-financed by Spirit, the Ministry of the Economy of the Republic of Slovenia, and the European Regional Development Fund.

by admin

Zero carbon footprint as a precondition for competitiveness of manufacturing companies

One of the key global challenges today are the climate changes. To help fight them, more and more manufacturing companies and other organizations are actively working to reduce greenhouse gas emissions and carbon footprint.

In most ambitious manufacturing companies, they intend to achieve zero carbon footprint, and to do that, they must take into account both direct emissions caused by themselves and indirect emissions that occur along their supply chain. Thus, carbon management is becoming a topic relevant not only for large corporations, but also for many other companies which are or aim to be their suppliers.

This means that the pressure on manufacturers will continue to increase in the coming years, as the carbon footprint will become an essential factor for their competitiveness.

Biggest part of greenhouse emissions are caused by energy consumption in the industry

Out of approximately 50 billion tons of greenhouse gases released into the atmosphere each year, about three-quarters are generated by energy consumption, of which more than 24 percent is in the industry.

This shows that the rational energy consumption is a fundamental condition for reducing emissions and carbon footprint.

The guidelines for systematic energy management are described in the ISO 50001 standard and include three key phases. The first is identifying areas in companies where energy consumption is highest. After that comes implementation of measures to improve energy efficiency. And finally, there is continuous monitoring and reduction of consumption.

Rising prices putting additional pressure on energy consumption optimization

In the industry, in addition to digitization and coronavirus, the most frequently discussed topic recently has undoubtedly been energy, and for several reasons. The main reason are soaring energy prices, which do not show any signs of normalization and which directly impact production costs. Despite increasing product prices and possible government subsidies, most producers will have to find solutions to higher energy prices by reducing their energy consumption.

For any kind of improvements mentioned above, reliable and properly processed data is required, which can only be obtained with the energy information system.

Reduce consumption, costs and carbon footprint in production with MePIS Energy

Based on years of experience, Metronik has developed its energy management solution, which is tailored to the needs of manufacturing – MePIS Energy. It includes all functionalities required for managing and reducing energy consumption.

MePIS Energy enables users to detect and eliminate hidden energy losses, and improves visibility for key stakeholders in energy consumption to shorten response times and carry out effective measures.

It provides manufacturing companies with real-time transparency and in-depth understanding of the causes of losses, as well as targeted monitoring of energy consumption with the help of proven techniques (e.g. M&T, CuSum).

With implementation of MePIS Energy you will gain:

• comprehensive overview of energy consumption in production processes and buildings
• collection and robust storage of all energy consumption data in one place
• quick detection of anomalies and ability to eliminate unnecessary consumption in real-time
• effective energy management at all levels of the organization, from operations to management
• enduring reduction of energy consumption and costs by 15 percent and more
• easier achieving of regulations regarding greenhouse gas emissions and related reporting
• the basis for setting objectives and verifying the effectiveness of measures following ISO 50001, ISO 14001, and ISO EN 16001
• solid foundation for effective carbon management and maintaining competitiveness in international supply chains

Experience of MePIS Energy users confirms that significant energy losses are identified and cut soon after its implementation, resulting in immediate savings. That is why, in most cases, the investment in MePIS Energy pays back in less than a year!

Moreover, with structured approach and measures, further improvements are ensured on the long run.

For more information on how to step-up energy management in manufacturing, please contact Vanja Tomažič at vanja.tomazic@metronik.si.

More information on MePIS Energy can be found here: https://mepis.eu/solutions/mepis-energy/

by admin

Happy New Year 2022!

by admin

How to effectively reduce energy consumption and cut greenhouse emissions in manufacturing?

Rising energy prices are putting a strain on manufacturing, driving up costs and forcing many manufacturers to rethink their energy efficiency strategies. Furthermore, with dire predictions coming from the scientific community regarding global warming, it is imperative that the manufacturing sector also contributes and reduces its carbon footprint. This puts life science and other manufacturers in an uncomfortable position, where they simply must react and optimize energy consumption.

A proven approach to reducing energy consumption is active energy management - systematic monitoring of the consumption with key performance indicators, detecting unnecessary losses, and developing initiatives for continuous improvements. At the core of such approach lies a platform, which enables it – the energy information system.

Based on extensive experience with energy management, Metronik has developed its own advanced energy information system MePIS Energy. By automatically gathering the data from meters and other data sources, correctly processing and contextualizing it, and displaying it in user-friendly dashboards, manufacturing companies can achieve immediate savings and also systematically tackle energy consumption through long-term improvement initiatives. In many cases, the introduction of MePIS Energy has a payback of less than a year!

For more information on how to reduce energy consumption in manufacturing with MePIS Energy see: https://mepis.eu/solutions/mepis-energy/

by admin

How can you reduce setup time for tablet press by 50%?

In Oral Solid Dosage manufacturing, plants need to produce millions of tablets daily. As tablets vary in shapes, weight, active substance dosing and other parameters, the production is broken down in multiple batches. Yet for every batch, the production setup process need to be completed. With hundreds of parameters to be defined, reviewed, approved and downloaded to machines, this process can become unnecessarily long!

The solution lies in digitalization of the setup process. With introduction of MePIS RM, cutting-edge recipe / parameter management software, the process is significantly simplified and thus optimized.

Find out more: link

by admin

Metronik at Making Pharmaceuticals expo in Coventry (UK), 5-6 October

Metronik will exhibit its innovative solutions for digitalization of life science manufacturing – MePIS at the Making pharmaceuticals exhibition and conference, which is going to take place from 5th to 6th October 2021 at the Coventry Building Society Arena in Coventry, UK.

Meet our experts at stand no. 305, and find out how MePIS solutions can help you optimise your production processes, avoid deviations, improve product quality and enhance regulatory and GMP compliance.

We are looking forward to seeing you there, in-person after a long time!

More about the event: LINK

by admin

State-of-the-art digitization technologies as a key element for a substantial leap in production efficiency

The issue of productivity has been around in the manufacturing world for decades. However, in practice, we have often seen failed investments and unexploited opportunities to improve production efficiency. Fortunately, a proven approach exists that delivers productivity growth and cost optimization on a constant basis – digitally supported approach of Operational Excellence (OPEX), which can also be upgraded with artificial intelligence (AI).

What is OPEX and how does it work?

The OPEX approach is based on an in-depth insight into manufacturing processes and monitoring of their performance through key performance indicators (KPIs), and systematic detection and elimination of root causes causing downtimes and losses.

The essence of operational excellence lies in the reduction of losses, for which acquisition and storage of manufacturing data in real-time are required. In the next step, the data is processed and transformed into clear, transparent and valuable information, with which we can identify opportunities for improvements.

At the core of the approach lies OPEX information system, which collects and processes manufacturing data, and provides relevant information to all key stakeholders in manufacturing.

However, technology is often only a part of the solution. Productivity growth and manufacturing costs decrease require also various skills and, above all, experience.

In addition to knowledge, experience and technology, what is essential is strategy. In practice, we too frequently encounter isolated solutions, focusing on individual problems. Instead, manufacturing improvements should be tackled comprehensively and with a clear vision of the ultimate goal.

Five key benefits of the OPEX information system

With the introduction of the OPEX information system and the operational excellence approach, we gain several significant benefits:

• better understanding of manufacturing processes for development of improvement measures for productivity increase and cost reduction
• easier detection of hidden losses with KPIs, using standard methodologies such as OEE and TPM
• faster response to events and anomalies in production, leading to shorter downtimes and losses
• elimination of manual data recording and often unclear / inaccurate paper logs more effective cooperation among key stakeholders such as management, operations and maintenance.

What does an upgrade of OPEX system with artificial intelligence bring?

Artificial intelligence is nowadays extensively used in numerous, especially consumer-oriented industries (e.g. banking, telecommunications) to support classical analytics and diagnostics.

Recently, with advancements in computer methods and predictive modelling, it is gaining ground in more complex environments as well, such as manufacturing. With proper preparation of data infrastructure, it can be used as decision-making support for various crucial processes – from manufacturing to planning and maintenance.

In combination with OPEX information system, artificial intelligence enables various process improvements, simplifications and accelerations, while relieving the burden on key decision-makers. Thus, on the one hand, it ensures faster identification of problems and easy interpretation of indicators that affect manufacturing efficiency. It enables the execution of simulations and predictions, with which critical events in production can be tackled before they even appear and affect productivity. Artificial intelligence is also increasingly used in product quality improvement, employee control and guidance, predictive maintenance, and optimal planning.

Although artificial intelligence in connection with production systems appears in more and more areas, its real boom in manufacturing is yet to come. In the future, in combination with the OPEX system and other tools, it will contribute even more to productivity growth and successful operations of manufacturing companies.

How can we help you at Metronik?

At Metronik, we have been working in the fields of automation and digitalization of manufacturing for over three decades. We employ numerous experts in automation, informatics, digitalization and manufacturing process-domain, which is why we can carry out the most demanding OPEX projects in various industries.

Based on our experience in increasing productivity and reducing production costs, we have developed a proprietary software solution MePIS OPEX. It consists of several modules that allow users to automatically detect and classify downtimes, calculate KPIs, provide useful information through control panels and dashboards, and offer advanced functionalities for reporting and analytics based on artificial intelligence.

OPEX is a web-based platform, which means that all functionalities are available anytime, anywhere, with the device of your preference (e.g. computer, smartphone and tablet), which makes the solution effective also for remote work.

Cutting-edge architecture and technology enable easy deployment of MePIS OPEX and seamless connection to existing information systems. Flexible artificial intelligence algorithms can be integrated with other applications to tackle productivity and production costs comprehensively.

For more information on how to improve productivity with the operational excellence system MePIS OPEX, please contact Vanja Tomažič by e-mail vanja.tomazic@metronik.si.

by admin

How German life science manufacturers set up their production environment

As a life science manufacturer, if you want to produce high quality medicines on consistent basis, you have to have well-defined process in place for how you define and set up machine parameters in order to produce them. This process includes all necessary steps for preparation on production, from creation of recipe parameter lists and their approval, to download to machines and storage – all while adhering to GMP requirements. The process is commonly referred to as recipe management.

Through time, recipe management process significantly progressed, from its start with pen and paper, to new and more advanced approaches, like completely digital. Depending on scale, type of production and digital progressiveness, several approaches can be used, each with its own pros and cons – and German life science manufacturers are all over the spectrum.

1) Recipe management with papers only

As the name already reveals, in paper-based recipe management recipes are written on paper, the whole approval workflow defined with SOP is done on paper, parameters are manually entered in the machines and used recipe parameters are stored in paper archive. Not many life science companies employ this approach, which was widely used in the past, before technological advancements enabled proper software support for process improvement. Typically, manufacturing environments with low scale, narrow product portfolio and/or older machines that have no recipe storage or external data import enabled are proponents of this approach.

Pros:

• No investment required,
• Robust approach (pen and paper),
• Self-sufficient manufacturing site (no vendors).

Cons:

• Highly inefficient (walking around, waiting for approval, manual entries...),
• High operational costs,
• Eco-unfriendly,
• Physical archive required with employees to manage it,
• Paper audit trail,
• Data integrity risks,
• Security concerns,
• Highly prone to errors,
• Lacking overview,
• Unfriendly for regulatory audits.

2) Recipe management on machines

The next option for recipe management is the one, where machines are capable of storing recipes and users manually select them for production from there. Recipe changes and updates are done on the machines, but the workflows defined with SOPs are executed manually, on paper. Archiving is done manually based on SOPs. Precondition for this approach are machines modern enough to enable recipes storage.

Pros:

• Usage of existing machines’ options,
• Recipes stored in machine – existing recipe can be reused easily,
• Digital data backup possible

Cons:

• Still inefficient (manual data entry and selection),
• Questionable data storage (additional yearly validation activities required, impractical for audits, storage limits),
• Lacking audit trail,
• Data integrity risks,
• Audit trail,
• Security concerns,
• Highly prone to errors,
• Lacking overview,
• Impractical for regulatory audits.

3) Recipe management with SCADA system

The third option to manage recipe parameters is through custom programmed SCADA functions. The scope of automation is dependent on functions programmed by the (local) system integrator on site personnel’s demand. That is why workflows can be partially covered by SCADA, and partially manually. Typically, this option is specific for each site, as also processes, local desires / requirements, capabilities and way of working of (local) system integrator vary site by site.

Pros:

• Custom solution tailored to processes in certain manufacturing site,
• Local support,
• Exploitation of existing, installed software.

Cons:

• Custom and complex solution,
• Still lacking complete functionality,
• Hard to scale up and leverage enterprise-wise,
• Expensive and difficult to maintain in the long run (high TCO),
• Lack of best practices and long-term vision for further developments and upgrades,
• Questionable full GMP compliance,
• Dependence on single system integrator (lock-in).

4) Recipe management with DCS system

The fourth option how to manage recipe parameters, is with dedicated modules in the DCS system. The installed modules can cover many aspects of recipe management, but they are proprietary to the provider of the DCS system and can have certain limitations. Typically, this option is used in larger manufacturing environments (e.g. API, biopharma), which already have existing DCS systems in place.

Pros:

• Comprehensive recipe management,
• Exploitation of existing, installed software,
• Unified software for production execution.

Cons:

• High investment,
• Vendor lock-in (1 provider),
• Potential rigidness and inability to adapt to site processes difficult to deploy to entire production site (not all machines are usually covered by DCS),
• Not appropriate for diverse and older sites (predominantly used in new sites)

5) Recipe management with dedicated centralized software

The final option is to manage recipe parameters centrally with a dedicated software. This way, the whole process is fully supported with a software solution that is adapted to it. Thus, the process runs smoothly, doesn’t burden employees, minimizes errors and deviations, and ensures full GMP compliance (e.g. complete audit trail, built-in security and user management, electronic data exchange among stakeholders and systems). After the workflow is executed properly, the automatic download to machines can be triggered and an operator just needs only to press start. Such an approach delivers maximal benefits in environments with sizeable manufacturing that have diverse product portfolios.

Pros:

• Comprehensive recipe management,
• Covering all regulatory, procedural and efficiency aspects (process, errors),
• Favorable cost-benefit.

Cons:

• Certain machines cannot be connected (too old) – then only download to machines is done as in approaches 1 and 2.

Due to the rising requirements for more production flexibility and quality control, recipe management has undergone a massive transformation. Nowadays, several smart solutions are out there to help life science manufacturers on their journey.

One of the most modern recipe management solutions is MePIS RM, which is used already by several  top 10 international life science manufacturers.

by admin

Avoid deviations, batch destructions and delays caused by human errors in recipe management

Errors and deviations occur in every manufacturing process. But when they happen in pharmaceutical industry, it means that people suffering from life-altering diseases may not receive their medicine in time or not in the expected quality.

A typical area – which is often neglected – where errors and deviations occur, is the process of defining and setting the production parameters on the process equipment. In most pharmaceutical manufacturing sites, this process involves numerous activities of which many are performed manually and on paper (e.g. review and sign-off, versioning, storing, parameter inputting) – all while we know how such way of working exposes manufacturers to high risks for errors…

The most effective remedy to mitigate such risks is digitization. By digitizing the defining and setting of production parameters, the process becomes bulletproof and error-free, ensuring that the patients get their much needed, high-quality medicines on time, every time.

The advanced solution for the digitization of the production parameters’ life-cycle is MePIS RM – discover more

by admin