Digital transformation in life science manufacturing.

Körber has officially certified HighByte Intelligence Hub for seamless integration with PAS-X MES as part of the Körber Ecosytem Partner Program. HighByte has achieved the “PAS-X MSI Plug & Produce” certification. This partnership empowers life sciences manufacturers to fast-track their digital transformation, enabling improved data visibility, enhanced operational agility, and increased manufacturing efficiency.

John Harrington (top)
& Lars Hornung

The Life Sciences industry is rapidly evolving toward the digital factory of the future, where seamless interoperability between systems, equipment, and devices is essential. Critical to this evolution is the convergence of Information Technology (IT) and Operational Technology (OT) systems—allowing real-time data flow across the entire manufacturing ecosystem.

Through this partnership, HighByte Intelligence Hub and PAS-X MES now natively connect using the PAS-X MSI Plug & Produce interface, a pre-validated, out-of-the-box standard. This seamless integration eliminates complex custom coding, reduces deployment timelines, and ensures reliable data exchange between systems, setting the foundation for advanced analytics, process optimisation, and enhanced regulatory compliance.

“Life science manufacturers face unique regulatory and digital challenges – from lack of data standardisation to siloed laboratory, maintenance, and supply chain data. These constraints create an agility paradox. While processes need to be closely controlled, analytics requires a real-time, iterative approach,” says John Harrington, Chief Product Officer at HighByte. “This is why the seamless integration between PAS-X MES and HighByte Intelligence Hub is so powerful. The collaboration demonstrates our commitment to providing a best-in-class integrated solution for our mutual customers and the life sciences market.”

“We are committed to delivering robust and flexible solutions that enhance pharmaceutical manufacturing processes,” explains Lars Hornung, Senior Principal Alliances & Technology Partners Software at Körber Business Area Pharma. “HighByte’s technology complements this vision by simplifying the integration of MES with data applications and automation sources through standard interfaces. Together, we help manufacturers streamline their digital initiatives, making real-time data a cornerstone of smarter, more flexible production environments.”

---

@WerumKarriere @HighByteInc #Koerber #Pharma #PAuto #MES

Partnership for seamless SAP's ERP Platform.

Endeavor Consulting Group has received the “PAS-X ERP Integration Ready” partnership certificate for its iMES solution and becomes an important partner in the Körber Ecosystem Partner program.

Pharma and biopharma companies can greatly benefit from integrating their Enterprise Resource Planning (ERP) system with a Manufacturing Execution System (MES) solution like Körber’s Werum PAS-X MES. While ERP systems primarily focus on managing various aspects of an organization's operations, such as finance, human resources, or supply chain, MES solutions step in to address the specific needs of the production. Integrating ERP and MES systems has a highly positive impact on life science manufacturing companies who can establish a seamless connection between the shop floor and the rest of the organization. With this integration companies can optimize forecasting and inventory management, effectively avoid production delays, and increase productivity in production.

In the past, Endeavor Consulting Group and Körber have collaborated multiple times to provide an out-of-the-box solution for clients with specific needs for integrating PAS-X MES with their existing SAP ERP software system. The PAS-X MES Suite digitally controls, monitors, and documents the manufacturing process in real-time. Endeavor’s solution “iMES” is a set of pre-packaged, SAP-configurable integration applications combined with an event monitoring system, designed to simplify changes to the SAP system should they be required. iMES follows the same design principles as SAP's standard software, offering configurability, flexibility, and ease of maintenance. It has been thoroughly tested for compatibility with recent SAP version upgrades, including SAP S/4 HANA.

"We are pleased to recognize Endeavor for achieving the 'Ready' level certificate with their integration tool, iMES. This accomplishment highlights their expertise and commitment to delivering high-quality solutions. As a partner, we are excited to collaborate and offer clients enhanced capabilities, seamless integration, and optimized operational efficiency between PAS-X MES and SAP's S/4HANA ERP software system," says Lars Hornung, Senior Principal Alliances & Technology Partners Software, Körber Business Area Pharma.

“iMES is a result of extensive experience and global design requirements, incorporating best practices. It can accelerate implementations, reduce risk and total cost of ownership. As a proud member of Körber's Ecosystem partner program, we are excited to bring our expertise and innovative capabilities to empower businesses in their digital transformation journey,” says Chris Chambers, Managing Partner, Endeavour Consulting Group.

---

@KoerberPharma @WerumKarriere @endeavorcg #PAuto #Pharma

Partnership program for equipment, machine, and system suppliers.

Körber has announced a new partnership program for equipment, machine, and system suppliers. With two different PAS-X MSI Plug & Produce partnership levels, vendors can now prove that they are able to use the MSI (message-based shopfloor integration) technology.

"As a certified partner, we offer a verified, reliable and configurable PAS-X MES connection as part of PAS-X MSI Plug & Produce, which provides our customers with seamless vertical machine integration within the shortest possible time," concludes Jürg Messmer, Head of New Business Packaging Machines, Körber Business Area Pharma.

Communication between shop floor equipment and an MES (Manufacturing Execution System) can be challenging if the IT systems do not have a common interface. That is why Werum PAS-X MSI Plug & Produce – an add-on to the market-leading Werum PAS-X MES suite – enables standardized message-based communication between the MES and the equipment or machines on the shop floor. Based on industry best practices, the technology allows a fast and easy integration of machines and automation systems into the pharmaceutical production environment. This leads to a significant reduction in manual configuration effort, with workload being reduced by up to 75%. PAS-X MSI Plug & Produce from Körber is increasingly seen as a standard in the industry and leverages the Concept Paper of the ISPE Plug & Produce Working Group.

With the new PAS-X MSI Plug & Produce partnership certificate, equipment, machine, or system suppliers globally can now become Körber Ecosystem Partners. “We believe that together with our partners we can deliver the difference for our mutual customers in the pharma, biotech or cell & gene industry,” says Lars Hornung, Senior Principal Alliances & Technology Partners Software, Körber Business Area Pharma. "For this reason, we have created a certification model that shows the added value of a standard integration we can bring to our joint customers.”

The “Ready” certification is a free, entry-level certification that shows that the partner company has a basic understanding of the technology and has implemented a system interface based on the MSI interface specification provided by Körber. “Certified” is the advanced certification level that proves that the partner company has implemented an interface and in addition has participated in a formal interface acceptance test. "As a PAS-X MES customer, we need to be sure that machine manufacturers can offer standard integrations of their products. This certification gives us the necessary assurance," says Daniel Degn-Hansen, IT & Automation Area Specialist, Novo Nordisk.

@KoerberPharma #PAuto #MES

MES for pharmaceutical and biotechnological production improved!

Werum further improved its best-in-class PAS-X MES/new technological features for accelerated MBR and EBR handling / all customers profit from innovations


In cooperation with the PAS-X User Community, Werum further improved the leading Manufacturing Execution System (MES) for pharmaceutical and biotechnological production. "We integrated new features and improved the usability, making working with PAS-X even easier and more efficient", says Robert Welter, Head of PAS-X Product Management, Werum IT Solutions GmbH. "PAS-X is a functionally complete and scalable MES out of the box, which widely automates actions that previously had to be performed manually."

Robert Welter

Accelerated MBR creation
The newest PAS-X version V3.1.6 provides many new technological features. The extended control of storage conditions and the automation of basic functions improve both production security and efficiency in creating Master Batch Records (MBRs) or executing Electronic Batch Recordings (EBRs). MBR creation is further simplified by the "External Parameters" feature based on generic Master Batch Records (GMBRs).

"Our customers face the challenge of managing a large number of packaging MBRs while also being required to quickly react to changes, e.g. in packaging design. These changes can be quite complex today", says Robert Welter. "The new PAS-X feature offers the possibility of making changes in the ERP and directly creating an executable EBR. Thus, the creation of individual product-specific MBRs becomes obsolete. In this way, we enable our customers to considerably reduce the number of packaging MBRs and really accelerate MBR creation."

Efficient EBR execution and release
The new alarm & event handling ensures an even better shop floor integration and thus guarantees continuous processes as well as a smooth information flow between PAS-X and the SCADA, DCS and Historian systems. Via interface, PAS-X directly retrieves the exceptions from Level 2 and allows the seamless assessment of all exceptions. This improvement enables QM personnel to go for a full "Review by Exception" (including Level 2 alarm & events) and allows the accelerated release of Batch Record Reports (BRRs).

The release process can be even further accelerated by the "Auto-Closure of BRR" feature. It automatically closes the BRR if there are no exceptions. As a result, QM personnel do no longer have to check batches without any exceptions and critical parameters so that a manual release is not required anymore.

Upgrades: Customers benefit from PAS-X innovations
"All our customers can benefit from continuous PAS-X innovations and improvements. New functions are provided through upgrades without compromising the stability of a running system. This is ensured by our mature upgrade procedures", says Robert Welter. "For a successful introduction of PAS-X, we also offer support and consulting services as well as PAS-X Content Packages. Along with the innovative features of the latest PAS-X version V3.1.6, our customers can thus achieve a high return on investment."

Long-time customers, such as the fast-growing generics manufacturer Actavis, have already ordered upgrades to the newest PAS-X version and are enthusiastic about all the benefits: "We currently upgrade to PAS-X V3.1.6 at our main manufacturing plant in Dupnitsa, Bulgaria", says Brandur Hauksson, Validation Manager, Actavis. "PAS-X V3.1.6 offers a significant increase in functionality. This enriched toolset gives us the ability to do exactly what we want and eliminates any need for customization."

Speeding up of MES project timelines

Pre-configured PAS-X content "Out of the Box"

Werum Software and Systems offers content packages for its customers "Out of the Box" to enable best practice based configuration of the PAS-X software.

When setting up PAS-X, the customer no longer needs to start with an empty application, but can instead utilize pre-configured content targeted to the specific processes of pharma and biotech companies. The new content packages, with their GMP-compliant templates, ensure an easy setup of the system and speed up the overall project timeline. They are based on the best practices of Werum customers and driven by the PAS-X User Community PFU.

Torsten Isenberg

PAS-X Rights and Roles Content Package
One of these Content Packages is the PAS-X User Rights and Roles Content Package. It is available for the configuration of PAS-X user rights based on global profiles targeted to GMP compliance and pharmaceutical manufacturing. The already included user profiles, with predefined rights, are designed for defined roles in a GMP organization. Examples include Shop Floor Operator or MBR Designer. These roles can be combined with each other, if needed. In line with Werum's project experiences, the "descriptive names" of the profiles make it clear which user these roles are targeted to.

"The pre-configured content along with supporting consulting services clearly defines a new standard and facilitates harmonization in the industry" says Torsten Isenberg, Director Head of Department Consulting & Training, Werum Software & Systems AG.

The User Rights and Roles Content Package considerably simplifies the configuration and maintenance of PAS-X's highly flexible user rights capability. Based on the clear and well-structured documentation of the rights and profiles, system administrators and project team members can save up to 95 % of the time usually required for the initial configuration and testing of rights.

Package aids pain therapeutics process plant

Software product ensures transparent management of starting materials in pharmaceuticals development at Grünenthal (D).

Grünenthal bundles all research
and development activities at 
its campus in Aachen (D).

The research-based international pharmaceutical company Grünenthal will deploy the PAS-X process development package. The group is leading in the field of pain therapies and invests more than a quarter of its revenues in research and development. Operating Werum's PAS-X process development, pharmaceutical and biotech companies can simplify and accelerate the modeling of manufacturing processes for pre-clinical and clinical studies. Grünenthal will initially install the package for substance tracking of clinical batches at its plant in Aachen, Germany.

"With PAS-X process development we are capable of tracking the use and consumption of all raw materials in pharmaceutical development," says Dr. Martin Lueck, Vice President Head of Pharmaceutical Development & Drug Delivery at Grünenthal. "This enables us to further increase the efficiency of our development activities."

In addition to PAS-X process development, Grünenthal will also deploy the PAS-X business functions master batch records, warehouse management and weighing & dispensing.

Human reliability in Middle East

Human reliability software company extends Middle East support

PAS has opened an operations office in Saudi Arabia, broadening and deepening its presence in the Middle East.

The Saudi Arabia expansion will enable PAS to meet growing demand in the region and serve key clients such as Saudi Aramco and SABIC. The Saudi Arabian office will further strengthen PAS’ regional capabilities that already includes offices in Bahrain and Doha, Qatar set up to service clients such as Qatargas, Qatar Petroleum, Kuwait Oil Company, Kuwait National Petroleum Company (KNOP), ADGAS, Petroleum Development of Oman, and many others.

“The expansion of our presence in the Middle East is a significant milestone. Many customers seek our expertise in minimizing human error by delivering critical process information in context to plant operators, engineers, and managers in the Middle East power generation and hydrocarbon industries. We’re helping plant personnel to make the right decision in time-sensitive situations, helping them to maintain a safe and productive operation.” said Bill Dennison, PAS Vice President of EMEA.

The additional Middle East office is part of the company’s broader plans to increase its presence worldwide. PAS has operations locations in the US, Canada, Australia, South Africa, Asia, UK and Europe.

Improving human reliability

New application improves human reliability by identifying safe operating limits

inBound™ from PAS improves vigilance of plant safe operating limits and exposes process safety risks 

PAS has released inBound, an application that makes plant operators continually aware of safe operating limits.

Boundry hierarchy example

Safe operating limit information is maintained by various groups within the plant and is not readily available to operators.  As such operators are generally unaware of the design and safety limitations of the processes they operate.  PAS has addressed this shortcoming with inBound, a layered application for PAS’ market-leading PlantState Suite© alarm management software. 

InBound aggregates, validates, and displays physical constraints such as a vessel’s Maximum Allowable Working Pressure (MAWP), design constraints such as relief valve settings, and safe operating limits.  These constraints may be manually entered, calculated, or imported into the software from engineering applications and databases.   

The application enables engineers to develop a boundary hierarchy and automatically detects and reports deviations from that hierarchy, such as an alarm setting that is higher than a pressure-relief valve setting.   This capability provides assurance that configuration parameter changes such as alarm limits and instrument ranges remain within the safe operating envelope of the plant.  

By displaying safe operating limits in real time and in context within the plant’s existing control system graphics, inBound enables operators to proactively monitor measurements and take action as needed to prevent violation of limits.  “A compelling use for inBound is the monitoring of environmental limits.” said Eddie Habibi, Founder and CEO of PAS.  “Exposing these limits in context enables operators to visualize the process’s proximity to boundaries in real time, and take action before an excursion occurs”. 

Software &engineering services improve plant operability and safety

Qatargas Selects PAS for Site-wide Alarm System Improvement Project

Qatargas, the world’s largest liquefied natural gas (LNG) producer, has chosen PAS’ PlantState Suite™ alarm management software and engineering services for an improvement project across all their units.

“We chose PAS to optimise our alarm systems.  With this project, we expect to reduce operator loading and facilitate plant safety, all in service of continuity of customer shipments.”; said Alae Sadic Al Hassan, Acting Chief Operating Officer – Engineering & Ventures, Qatargas.

PAS’ PlantState Suite™, which is a comprehensive alarm management and operations support software suite, will be utilized on the project to provide event analysis, documentation and rationalization, auditing and enforcement, and dynamic alarm management. Post-project, the software will then be used to properly monitor and maintain the alarm system.

“We are honored that Qatargas chose PAS for this important project to extend their leadership in process safety, reliability, and performance,” said PAS President, Chris Lyden. “We are proud to be their partner in this endeavor.”

Management of change

Integrity iMOC detects inadvertent and unapproved automation configuration changes to fortify control system security and safety

PAS has released Integrity iMOC, the next evolution in electronic Management of Change (MOC) software. Integrity iMOC ensures that all changes made to a plant’s automation systems are detected and reconciled with specific management of change cases.

While most countries have regulations governing management of change for such things as process chemicals, equipment, documents, facilities, and procedures, few have specified requirements for management of change for automation systems. As a general rule, if an automation change affects other items that clearly require change management, then a rigorous MOC process is to be followed. However, critical changes are often made to automation systems with no record of whether they were approved or not, leaving the systems vulnerable as these undocumented changes carry the potential to be destructive. Only by ensuring that all configuration changes (except for the most fundamental changes required to operate the plant, such as setpoints, outputs, and control modes) are included in the MOC process and reconciled against outstanding MOC cases, can companies be certain their automation systems are secure.

“Undocumented and unapproved changes to automation systems have been identified as contributing factors in a number of process industry incidents and accidents.” said PAS President Chris Lyden. “With the advent of new viruses that affect the interaction of controls with the process, ensuring that all automation configuration changes are detected and reconciled with MOC cases is an essential element of control system security.”

Integrity iMOC provides a graphical environment for the definition of MOC workflows, which includes describing each state within the workflows, as well as the checklists and required transitions for the states. As an Integrity-enabled application, iMOC takes full advantage of the capabilities of PAS’ Integrity ™ software, which maps the configuration of more than 50 different automation systems and tracks all changes to them. Additionally, it reduces the time required for engineers to acquire design information, since it automatically identifies all links and interdependencies for any automation entity under change management.

As part of the installation services for Integrity iMOC, PAS can integrate it with a plant’s existing MOC system, configuring it to act as a subordinate to that system. PAS can also implement an S95-compliant plant asset hierarchy to link MOC cases to specific parts of the plant as is often done in general MOC systems.

Strategic partnership for comprehensive substation automation

Process software and engineering services provider PAS has partnered with NovaTech. NovaTech will offer PAS’ automation and operations effectiveness solutions to increase the safety, productivity, and reliability of their client’s facilities.

“Our clients routinely request alarm management, high performing operator interfaces, and comprehensive configuration management solutions to operate their facilities safely and profitably. We recognized PAS’ leadership and expertise in these areas and decided to introduce them into our portfolio. This will strengthen our competitive advantage and give our clients a more comprehensive automation solution,” said NovaTech President, Aubrey “Buz” Zey. 

“We are very excited to have NovaTech as an alliance partner. Through this partnership, NovaTech will take PAS solutions to industries and clients that we would not typically have exposure to, creating new opportunities for both companies,” noted PAS President, Chris Lyden.

PAS’ operations effectiveness solutions include alarm management software, control loop performance software, and high performance Human Machine Interfaces (HMIs). PAS’ PlantState Suite™ is a comprehensive alarm management and operations support software suite, providing event analysis, documentation and rationalization, auditing and enforcement, and dynamic alarm management. PAS also designs and implements high performance HMIs that improve situational awareness, enabling console operators to make quick and accurate decisions.

NovaTech will also resell PAS’ automation effectiveness solution, Integrity™ software, which maps the configuration of automation systems, including Distributed Control Systems, Programmable Logic Controllers, Historians, and Safety Instrumented Systems. Integrity software provides comprehensive configuration management and management of change within and among disparate vendor’s automation systems, which facilitates compliance with industry standards such as NERC CIP.

Guide to alarm management

The definitive guide to best practices for effective alarm management and a concise summary of the new ISA standard

PAS has recently published the second edition of The Alarm Management Handbook by Eddie Habibi, PAS Founder and CEO, and Bill Hollifield, PAS Alarm Management Principal Consultant. It is the most comprehensive best-practices book available for designing and maintaining an effective alarm management system.

Ineffective alarm systems continue to haunt the processing and power industries worldwide, contributing to plant upsets and shutdowns. Alarm management improvement has been identified by many industrial companies as a critical business and safety improvement imperative in recent years. In response to this market need, PAS published the first edition of The Alarm Management Handbook in 2006. With the release of the new ANSI/ISA-18.2-2009 Management of Alarm Systems for the Process Industries, PAS has updated the book to incorporate the ideas presented in it. This new standard sets forth the work processes for designing, implementing, operating, and maintaining a modern alarm system in a life-cycle format. The 2nd edition includes a summary of the standard’s scope, regulatory impact, requirements, recommendations, and other details.

The new edition also includes much additional practical information on benchmarking alarm system performance, developing a comprehensive alarm philosophy, solving nuisance alarm problems, performing alarm rationalization, implementing advanced alarm handling techniques, and improving the operator HMI for optimum situation awareness and incident mitigation.

“The Alarm Management Handbook is a very practical guide to implementing an alarm management program, presented in a unique and entertaining style,” says Nicholas P. Sands, ISA-18 Co-Chair. “This edition provides new information, and ties the guidance in the previous edition to the new ISA-18.2 standard.”

New sales VP at processing industries supplier

PAS has appointed David Vinzant as Vice-President of Sales. He has over 30 years of industry experience and joins PAS from SunGard Energy where he was the Chief Operating Officer and Head of Sales. Prior to SunGard, he held executive-level positions at Invensys and TransEnergy.

Mr. Vinzant, who holds a Bachelor of Science degree in Chemical Engineering from Texas A&M University, has global experience in multiple industries, including Oil & Gas, Refining, Petrochemical, and Utilities. For the last 15 years, he has managed customer facing activities for all phases of sales and delivery of implemented software and industrial automation solutions.

"PAS provides unique solutions critical to the safe and effective operation of our customer’s production assets,” he says. “I look forward to working with our customers to meet the growing and changing needs of their business, as well as contribute to PAS’ continued growth.”

“I’m very excited about David joining our team here at PAS. His extensive background in sales will help strengthen our leadership within our target markets,” says Chris Lyden, President at PAS.

Safety management compliance

New software facilitates process safety management compliance

PAS has released a new version of its comprehensive alarm management and control loop optimisation software with new features to improve plant safety and productivity.

PlantState Suite Version 6.5 provides new features to help improve process safety and to demonstrate good practice in accordance with process safety standards IEC 61511, ISA 84 and compliance with the OSHA 29 CFR 1910.119 rule for plants handling highly hazardous chemicals in the U.S.

To facilitate improved process and plant safety, PlantState Suite Version 6.5 now incorporates the ability to audit and enforce control system parameters when a pre-configured event occurs. This capability provides a mechanism for proving the proper execution of control-system and safety-instrumented-system shutdown routines. It acquires the necessary information automatically, thus precluding the need to manually prove the functionality at a subsequent time.

Change management is another important factor in safety lifecycle management. PlantState Suite Version 6.5 is now integrated with PAS' Integrity(tm) Software, which maps and tracks the configuration of the industry's major control and safety instrumented systems. With this capability, users can access control strategies and change management details in the context of any alarm or event with a single click, thus enabling faster and more accurate troubleshooting.

"Helping our customers to improve their safety and regulatory compliance, while simultaneously improving their bottom line, is PAS' mission. The new capabilities of PlantState Suite Version 6.5 are targeted specifically at these needs," says Chris Lyden, PAS President.

New VP of technology

PAS recently appointed Jim Huff as Vice-President of Technology. He has over 25 years of industry experience and will use this extensive knowledge to lead the company's technology and solution marketing strategies that shape PAS' go-to-market, corporate, and solution offerings. He joins PAS from Invensys where he was Vice-President of Product Marketing and Portfolio Management.

During Jim Huff's career, he has held a variety of roles spanning the engineering & services, consulting, and marketing disciplines with leading companies such as Emerson, Apsentech, and Invensys.

As PAS' Vice-President of Technology, he will be responsible for bringing the innovative technologies at PAS to market while serving on the leadership team to drive ongoing operations and further alignment of PAS' solution strategies with customers' need for operational and automaton effectiveness.
"I'm excited to have Mr. Huff on board with us here at PAS. He has been a long time business associate and I'm confident in his ability to help PAS develop and bring its technologies to the market. His years of industry experience will help PAS to develop solutions that are maximally aligned with our customer's business goals," says Chris Lyden, President at PAS.