rfXcel provides SaaS (Software as a Service) based solutions that enable pharmaceutical companies to quickly meet their serialization, traceability, and compliance needs.

rfXcel offers private-cloud solutions which are fully validated and controlled by their customers who manage “what”, “how” and “when” changes are deployed.  As one of the first and longest-lasting providers in this space, rfXcel delivers the most robust features to the pharmaceutical industry and is committed to providing standards-based, open-solutions that integrate with all trading partners, governmental agencies and end customers.

www.rfxcel.com

PQE is a complete quality solution provider operating in the life science industry since 1998.  Thanks to the 16 offices worldwide from Japan to USA, we can rapidly support you anywhere you require in the following areas:  Data Integrity Assurance & Computer System Validation, Qualification & Engineering, Compliance, Regulatory Affairs and 3rd Party Audits.
Our unique capabilities enable companies to achieve and maintain compliance with FDA, EMA and other international, regional and local regulatory agencies.
We will support you to find the most sustainable way to develop practical and tailored plans that align global quality capabilities with your business strategy.

www.pqe.eu

Adents is a leading software company providing solutions for unique product identification and traceability to help Marketing Authorization Holders (MAHs) and Contract Manufacturing Organizations (CMOs) adapt to market changes and comply with regulations on drug traceability.

• Adents Seriza, a serialization solution for manufacturing sites, selected as preferred solution by Siemens for its customers
• Adents Prodigi, a Cloud solution jointly developed with Microsoft and empowered by Azure technologies, allows for secure data exchange and helps leverage the power of serialization data.

Adents operates globally with offices in Europe and in the United States as well as with a global network of solution partners.

For more info, visit 

www.adents.com

The clients benefit from Systec & Services’ experience in their core businesses in. the Life Sciences industries. This orientation and focus allows us to provide the highest level of customer services.

Focusing our efforts on a few target markets such as pharmaceuticals, biotechnology, medical devices, active pharmaceutical ingredients, cosmetics and consumer goods has a big advantage: We can offer a wide range of top services at competitive prices which ultimately provide our customers with more efficiency.

Systec & Services is a full-services system integrator that offers a wide range of products and services to regulated industries:

• Business and Enterprise Manufacturing Intelligence solutions.
• Systec & Services Life Sciences Intelligence System LiSI allows customers in regulated industries to increase their quality, productivity and transparency. All relevant sources of data can be retrieved, correlated, presented and analyzed.
• Professional services for the optimization of production management.
• Based on the requirements of regulated industries, we offer various tailored MES software solutions: ProductionCentre for Medical Devices, PharmaSuite™ for Pharma and BioTech and CPG Suite for the consumer goods industries.
• Process and System Application Consulting and MES Recipe Management.
• Professional project services and innovative software solutions are aspects of a software project‘s success. Pre-consulting as well as maintenance and support after-sales maintenance and support ensure in the end total success. Systec & Services supports you thoroughly and professionally – across the entire project life cycle.
• Successful Track & Trace implementation.
• With comprehensive skills and expertise in track & trace solutions, project and program management, we ensure successful serialization implementations.

As a system integrator with locations in Karlsruhe, Germany, Bad Saeckingen (Germany, close to Swiss boarder) and Cary, North Carolina Systec & Services is located where their customers are. Since its founding, Systec & Services has enjoyed continuous growth in terms of sales and number of employees.

www.systec-services.com

Videojet Technologies is a world leader in industrial coding and marking solutions with a dedicated global pharmaceutical team supporting organizations and supply chain partners with solutions, certificationsand fast, reliable service.

A product portfolio including thermal inkjet, laser marking, continuous inkjet and labeling provides consistent, high-quality serialization and traceability codes, helping the pharmaceutical and medical device industries safeguard their products against counterfeiting and protect consumer safety. With a wide range of technologies addressing virtually any application, Videojet is the expert in realizing the specific requirements of a wide range of healthcare applications.
With decades of knowledge, Videojet Technologies’ expertise in industry standards and global regulations makes them the right partner for understanding complex coding needs. Videojet solutions code 10 billion products a day worldwide, playing a vital and responsible role in the world. With over 4,000 associates serving 135 countries, Videojet has the capability to provide local service through global resources.

www.videojet.de

Enterprise System Partners (ESP) is a leading global consulting and project engineering company – supporting manufacturing IT solutions for the life science industry since 2003.

We offer specialist support and consulting services exclusively for manufacturing  and supply chain operations in biotechnology, pharmaceutical and medical devices, with core focus on Manufacturing Execution Systems (MES) and serialization.

We design, implement and integrate Manufacturing Execution Systems (MES).  Our key people have a collective knowledge of the entire systems landscape including Enterprise Resource Planning (ERP), Process Automation and Laboratory Systems.  In short, we understand how it all fits together and can deliver system projects for individual systems or an integrated solution across the systems landscape.

Our primary focus is delivering value to our clients by the selection and implementation of appropriate systems to achieve their goals, such as, increasing efficiency & flexibility, reducing the burden of compliance & meeting regulations (e.g. serialisation).   We have earned the respect of many of the keys vendors, yet remain vendor independent, so we can represent your needs exclusively.  We can operate at both site and corporate levels to achieve the best approach.  We will leverage experience and cost from past projects both within your corporation and from our expertise gained throughout our industry.

www.EnterpriseSystemPartners.com

World class through Efficiency & Transparency

Integrated processes, from shop to top floor, from planning to distribution, is a strategic objective but yet remains a major challenge for most companies in the regulated industry. Full benefits cannot be achieved by just installing alone a system for process control. To reach that full potential – situational analysis, specifically tailored concepts and efficient implementation strategies must be developed in close alignment with the company’s organisation, associated culture and established processes.

We at prime4services actively engage and support your organisation to realise the maximum use and optimal potential across all processes and company levels. With our agile and innovative approach we ensure an optimal and efficient implementation of projects.

Use our skills and rich experience for your benefit!

Our methodology-based approach brings together processes, technologies and people. This holistic approach leads to a solution that makes optimal use of both existing and new systems / resources – neutral and vendor-independent.

www.prime4services.com

Rockwell Automation Inc. (NYSE: ROK), the world’s largest company dedicated to industrial automation and information, makes its customers more productive and the world more sustainable. Headquartered in Milwaukee, Wis., Rockwell Automation employs about 22,000 people serving customers in more than 80 countries.

The most successful pharma and biotech organizations are rigorous about their processes, especially as they relate to better understanding of manufacturing operations, process control, validation and quality improvement. By applying advanced technologies and integrating production processes  with the rest of the manufacturing enterprise, Rockwell Automation helps to reach higher quality products, less rework, increased profits and a distinct competitive advantage.

PharmaSuite™: MES for Life Sciences industry
Rockwell Software PharmaSuite™, within an electronic batch record framework enables a rich set of capabilities such as weigh-and-dispense, electronic batch recording, equipment management (tracking, e-logbooks), material track and trace / batch geneaology, shop floor logistics, in process control, review by exception. Rockwell Software  PharmaSuite™ can easily connect the automation layer as well as other level 3 and level 4 sistems (ERP, LIMS, CAPA, scheduling, production analytics systems, etc) and  help companies optimizing process operations, lower manufacturing risk and reducing costs while complying with current GxP regulations.

Longstanding life sciences industry experience combined with the Rockwell Automation best-of-breed technology delivers a unique offering well suited to the fast-paced evolution of pharma and biotech companies.

www.rockwellautomation.com

Movilitas was founded in 2006, and today employs nearly 200 experts around the globe of which approx. 50 are exclusively dedicated for and experienced in Track & Trace/Serialization.

Movilitas is an expert partner in the domains of Track & Trace/Serialization, Warehouse Management, Manufacturing, Analytics and Mobile. All these domains combined make Movilitas a key player in Supply Chain Integrity.

Movilitas is the world market leader for the implementation of SAP Track & Trace solutions. Movilitas have had an exceptionally close relationship with SAP for many years and is already involved with several clients implementing the new SAP Track & Trace solution, “SAP Advanced Track & Trace for Pharmaceuticals” (SAP ATTP). Movilitas have been implementing SAP based T&T solutions for over 9 years, and our track record of success means we have an enviable set of USPs for SAP ATTP and SAP OER/AII that no other competitor can match.

www.movilitas.de

Our vast production experience in labels, leaflets and system solutions for the pharmaceutical industry since 1933 combined with passion for digitalization makes us a true specialist for tailor made solutions. The latest offering is an alternative way to comply with the Falsified Medicines Directive 2011/62/EU. 

We support your track and trace project with Pre-Serialized Labels. Furthermore we have a label solution, which combines the serialization with the anti-tampering device in only one label. The customizable Pre-Serialized Labels are possibly the answer to your special serialization case e.g.:
- small batches,
- repackaging,
- manual packaging,
- special packaging size,
- pouches or dose packaging
- or as a backup to fulfil the deadline.

But it can even be your standard:
- save investment,
- save space,
- save time
 
and outsource the complex serialization processes.

Serialized, produced and 100% verified according to the global anti counterfeit legislation.

Upgrade your serialization project with flexibility.

www.baehren-druck.de

Laetus ist weltweit führender Anbieter innovativer Qualitäts- und Sicherheitskontrollsysteme und kompletter Track & Trace-Lösungen für die Pharma-, Kosmetik-und FMCG-Industrie. Mit 40-jähriger Erfahrung und  weltweitem Netz für Verkauf, Service und Projektmanagement sorgen wir dafür, die Qualität Ihrer Produkte und die Effizienz Ihrer Produktion zu erhöhen. In unserem Fokus stehen technologische Innovation und hohes Engagement für unsere Kunden und Partner. Dies hat unsere Marken zu Marktstandards in Codelesung, Qualitäts- und Füllgutkontrolle gemacht – mit über 18.000 verkauften Systemen weltweit.

www.laetus.com

Now a Certified B Corporation, OPTEL is a leading multinational provider of traceability systems, and its mission is to use its innovative technologies to create a better world through responsible capitalism. The company’s renowned solutions ensure the quality of consumer health products and help stop counterfeiting of pharmaceuticals and medical devices throughout the world. OPTEL is also adapting its technologies to create efficiencies in various other sectors ─ from health-related industries to smart manufacturing and more, all can benefit from global traceability. OPTEL’s expertise will allow diverse industries to measure, inspect, control and track a variety of elements to improve quality and make better use of resources.

www.optelgroup.com

Secure and straightforward, all-in-one print & verification solution

HSA Systems is a leading manufacturer of industrial inkjet equipment. Our core business is developing and manufacturing high-resolution inkjet printers, as well as a range of other products for coding, marking and commercial printing applications.

For the pharmaceutical industry, HSA Systems has developed a unique all-in-one print & verification solution. Unlike other systems in the market, the HSAJET® Print & Verification system controls all units from only one interface and provides all the necessary features to comply with important international regulations and standards, among other things: 

• Print on blisters, labels, folded and un-folded cartons
• Marking of packaging, including ECC200 Datamatrix codes according to GS1 standard
• Verification and validation of 1D/2D codes in accordance with ISO 15415/15416
• Object Character Verification (OCV) at a score level of 1-100
• Software in compliance with 21 CFR part 11

The HSAJET® print and verification solution provides human machine interface (HMI), printer, vision and controller as well as design, print and verification software in one package.

The HSAJET® Print and Verification solution is available as integration kit as well as turnkey systems. HSA Systems offers the PV650C Pack Handling Unit for folded cartons and the PV950F Flat Carton Handling Unit for lay-flat media such as un-folded cartons. Both systems are configurable for in-line or off-line use.

The system is ready for integration in other pack handling modules. The I/O connection panel enables easy connection of HSAJET® printer, controller and software to customer’s choice of camera and transport unit.

HSA Systems is HP OEM partner and our printers are built on reliable HP TIJ 2.5 technology providing consistent high quality printing with virtually no maintenance. 

HSA Systems has provided printing solutions to a vast number of small, medium and large size pharmaceutical companies and machine manufacturers.

www.hsasystems.de

Goldfish ICT is a specialized SAP consulting agency focused on the Life Sciences/Chemicals and Food/Agriculture industries. Our branch focus leads to better business process understanding whereas our best practice approach and solutions help customers face their day to day business challenges, beyond only the level of IT. Our consultants are passionate and dedicated because of the nature of these industries, where it’s all about consumer/ patient safety, reducing business complexity and helping our customers to innovate.

Goldfish ICT supports businesses that want to perform excellently. We deliver the support they need in (re)structuring/optimizing their business processes and implementing user-friendly solutions in validated and non-validated environments. Batch management, labelling and scanning, production planning and execution, traceability and serialization are just a few examples where our solutions and standardized approach are ‘fit for purpose’. 

To better support our global customers, Goldfish-ICT joined the itelligence group on July 1st, 2017. itelligence is a leading global SAP service provider which shares our strategy and vertical focus.

www.goldfish-ict.com

Werum IT Solutions is the internationally leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical indus¬tries. Its out-of-the-box PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies but also by many mid-sized manufacturers.
Werum provides integrated IT solutions for all phases of production – including process development, commercial production, and packaging as well as track & trace serialization. PAS-X MES helps pharma manufacturers to increase efficiency, im¬prove productivity, and meet regulatory require¬ments.  The company is headquartered in Lüneburg, Germany, and has many locations in Europe, America, and Asia. Werum is part of Medipak Systems, the Pharma Systems business area of the international technology group Körber. Körber unites around 11,500 professionals in industry-leading companies worldwide, achieving annual earnings of 2.3 billion Euros.

www.werum.com

Tradeticity provides cost-effective serialisation solutions, designed from the ground-up with quality compliance in mind. Our system is in accordance with GAMP 5, and is capable of end-to-end serialisation (to be compliant with the EU Directive 2011/62/EU) and full, item-level Track and Trace. Whilst the final solution we provide is bespoke for our client’s needs, the core system is standard, therefore easy to document and maintain compliance.

Our team was assembled solely for this purpose, and includes IT specialists, and pharmaceutical compliance specialists who have many years’ experience at the biggest software and pharmaceutical companies in the World, giving us a deep understanding of the challenges faced.

We are proud to be a Croatian company, giving easy access to pharmaceutical manufacture in South-East Europe, but equally we have an International presence, with offices in US, Brazil and UK.

www.tradeticity.com

HGP is one of the leading business consultancies specializing in the healthcare industry. Based in Switzerland, with subsidiaries in Germany and Singapore.
Our expertise lies in the efficient use of technology, streamlined processes and standardization that is required in today’s healthcare industry which researches, produces and markets in global networks.
HGP provides expert consultancy for

• Paperless Manufacturing and MES
• Serialization / Track & Trace
• Information Risk Management
• CSV / IT Quality Management

Our clients are global corporations and medium size companies - manufacturers as well as suppliers - in the following fields: pharmaceutical and bio-pharmaceutical industry, medical devices and related industries.
Our international approach with sites in strategically important pharmaceutical industry locations enables us to carry out even global projects with the necessary expertise and presence.

www.hgp.ag

Indegy protects industrial control networks against operational disruptions caused by Cyber Threats, Malicious Insiders and Human Error, and ensures operational safety, continuity and reliability, by providing real-time visibility and control. The Indegy platform delivers unparalleled visibility into the critical control-plane of ICS networks to identify threats that put industrial automation controllers (PLCs, RTUs, DCS) and the processes they manage at risk. It maintains a comprehensive asset inventory and captures all changes to these assets, whether performed by malware or human, and whether authorized or not.

www.indegy.com

Smart Manufacturing Hub delivers industry related content for professionals from manufacturing & process industry sectors. Among the issues covered are Energy Efficiency, Manufacturing IT (e.g. Manufacturing Execution Systems), Chemical Manufacturing Strategies and Maintenance & Reliability issues.

www.smart-manufacturing-hub.com

PharmaVOICE magazine provides readers with insightful and thought-provoking commentary about the challenges and trends impacting the life-sciences industry in a multiple-perspective format through articles covering a range of issues from molecule through market. PharmaVOICE’s more than 41,000 BPA-qualified subscribers are also kept abreast of the latest trends and information through additional media resources, including WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.

www.pharmavoice.com