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Year: 2018

PACIV at the 2018 CSIA Executive Conference

Rick Straw, President, and Jorge L. Rodríguez, CEO, recently attended the Control System Integrators Association (CSIA) Executive Conference in San Francisco, CA. At the conference, our CEO Jorge Rodríguez participated as panelist in the “A Tale of Two Hurricanes and an Earthquake” presentation. He shared the experiences and lessons learned regarding “Disaster & Recovery” and “Business Continuity” after going through Hurricane Maria in PACIV’s offices in San Juan, Puerto Rico. PACIV has been a member of CSIA for over 10 years. There are 500 integrators from around the world that attend the conference to benchmark best practices, discuss challenges facing our businesses and for suppliers to present new equipment and hardware. Themed “Growth...

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ISA Ireland Conference: Cybersecurity for Automation

Brendan Hyland, Business Development Manager, and Denis Gorey, Vice President Operations at PACIV-Ireland attended the ISA Cybersecurity Conference at Rochestown Park Hotel, Cork. The conference focused on Industrial Cyber Security and preventing/mitigating the damage that a cyber-attack will have on Automation Systems – across e.g. Manufacturing, Critical Utilities, Healthcare and Transportation sectors. International experts, from leading Control Systems Manufacturers, presented practical solutions to increasing Cyber Security difficulties – so systems and infrastructure can be better protected. Additionally, the conference highlighted how to identify cyber threats, mitigate risks & limit exposure of control systems and networks, introduced proven industrial...

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FDA’s Data Integrity (2016), Part 11 (1997) and “Appropriate Controls” (1978) – are we back to the future?

Over 25 years ago, as an Automation Engineer, I was responsible for process automation systems (DCS and PLC’s) at a pharmaceutical company. The company happened to be the very first one to get an FDA “Warning Letter” on “computerized systems”. Computerized systems within the industry were regulated at that time solely by 21 CFR 211.68. In 2015 and 2016, approximately 80 percent of all warning letters include a “data integrity” component. The leading observation within that 80% continues to be based on 21 CFR 211.68, a 40-year-old ruling. At the time we received the “Warning Letter”, a task-force of Automation Engineers was formed to understand the FDA’s 211.68 ruling (1978). We found the 1983 “Guide To Inspection of Computerized Systems in Drug Processing” used by FDA Inspectors to be...

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PACIV at PIA’s 2017 Annual Meeting

PACIV, a PIA Affiliate Member since 2009, was present at the Pharmaceutical Industry Association (PIA) – Annual Meeting held February 22, 2018 at the Sheraton Puerto Rico Hotel & Casino in San Juan. Under the motto “Growing Our Future – Seeds of Innovation”, PIA’s annual meeting this year was about the challenges and opportunities our industry faced after last year’s hurricanes and as we move towards a new business environment. The event also discussed how to build a robust and resilient energy system, what sustainable healthcare reform for Puerto Rico looks like, as well as emphasizing the importance and contribution of the bio-pharmaceutical industry to the overall economy of Puerto Rico. PACIV is proud of being a PIA Affiliate Member, representing our leading role...

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DeltaV Certification Course in PACIV USA

Recently, our PACIV Puerto Rico Engineering Leader, Jean Paul Pepin, traveled to the USA office and led a week-long DeltaV workshop for some of our USA and Ireland associates. (FROM LEFT TO RIGHT: PACIV associates Eric Broyer, Allison Beddow, Jonah Pettet, Jacob Dispennett, Vito Maglio, Ben Kahn, Jean Paul Pepin and Michelle Vander Missen.) The course allows our associates to sufficiently define system capabilities, define nodes, configure continuous and sequential control strategies, create process alarms, operate the system, troubleshoot the system and modify operator displays. PACIV utilizes a virtual DeltaV™ system to practice and review course materials. The course also touched on the DeltaV™ Batch application;  it is planned...

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OSIsoft University Training Certificate of Completion

Brendan Hyland, Business Development Manager at PACIV Ireland, recently accomplished the Certificate of Completion of the Partner – Product Learning of OSIsoft University training. In this Partner Bootcamp, Brendan had the opportunity to learn the basic technologies of OSIsoft. This course is an accelerated course bundle conceived specially for partners. The material was delivered at a rigorous pace, but with ample time to develop skills. Brendan was exposed to the working of the PI System and Applications, Architecture and Analytics from a wide range of perspectives: implementation, administration, end user, and integration. The primary goal of this course is to the provide a solid grounding in the OSIsoft technologies to bring maximum value to our customers. At PACIV,...

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2017 PACIV Annual Meetings

Recently, PACIV held its 2017 Annual Meeting in all its offices to discuss industry context, strategic objectives and provide all the associates with the 2017 Year in Review as well as the 2018 Forecast, Insights and Objectives. (TOP PICTURE CLOCKWISE: Associates from PACIV Puerto Rico, PACIV Ireland and PACIV USA.) Additionally, acknowledgments & awards were given to the associates in recognition of their years of service as well as Perfect Attendance for the year. Our Rhode Island team. At this year PACIV Ireland Annual Meeting, the new associates were welcomed into the PACIV family. The PACIV Ireland office has seen enormous growth the past year and the meeting helped associates come together and learn more about the company. At the PACIV USA Annual Meeting, the Perfect...

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ISA Ireland Honors & Awards at University College Cork (UCC)

Brendan Hyland, Business Development Manager/Director at PACIV Ireland, recently attended the ISA (International Society of Automation) Honors & Awards Ceremony at University College Cork (UCC). (TOP PICTURE: Brendan Hyland and John Murphy, ISA Ireland President.) ISA holds this annual ceremony to acknowledge and encourage excellence for those training for careers in Instrumentation, Systems and Automation. This program provides an opportunity for ISA to recognize outstanding individuals for the contributions they have made to the Society and the automation industry. PACIV as an ISA Ireland Section Partner, continues providing ongoing support and we are delighted to be a sponsor and represent at these activities that clearly show the industry’s awareness and support...

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PACIV Baseball Family Day

Recently the PACIV Puerto Rico office sponsored the local baseball team “Los Cangrejeros de Santurce” and gained access to the Baseball League Season games. The associates were able to attend and enjoy the games throughout the season with their family and friends. (TOP PICTURE: View of the Hiram Bithorn Stadium from the luxury booth the PACIV associates enjoyed the games.) More over and as part of our sponsorship for the team “Los Cangrejeros de Santurce”, PACIV was invited for a Family Baseball Day. At the Family Baseball Day, the associates and their families watched the game from one of the luxury boxes and enjoyed hors d’oeuvres and drinks. The associates also enjoyed a visit from the Cangrejeros team President, Justo Moreno, who interacted with the associates,...

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Luis García & Amilcar Canales Completed Assignment at Indianapolis

PACIV Puerto Rico associates Luis García and Amilcar Canales, both Validation Engineers I, recently relocated to Indianapolis for eight (8) weeks and successfully assisted in a large Waste Water Treatment Facility Project and Lilly’s Global Serialization Program respectively. As members of the Automation and Quality team, Luis and Amilcar supported automation activities for the startup of a two-pump wastewater lift station and the development of Serialization Program cases. In addition to supporting our client needs and enhancing their professional careers, the trip was also a wonderful adventure. They were able to visit the Indianapolis Motor Speedway Museum and see around the Indiana area. (TO THE RIGHT: Amilcar Canales and Luis García at the Indianapolis Motor Speedway...

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Joshua Gomez Completed Assignment at Ireland

PACIV Puerto Rico associate Joshua Gomez, Automation/Validation Engineer I, recently successfully completed his eight (8) weeks relocation assignment at PACIV Ireland. Joshua joined the PACIV Ireland Instrument Service Provider (ISP) team, and his duties included Inspection, Tagging, Shipping and Vendor Turn-Over Packages (VTOPs) development for Lilly Instruments received on site. (TOP PICTURE: Joshua visiting the Cliffs of Moher. TO THE LEFT: Joshua visiting the Giant’s Causeway.) In addition to supporting our client needs and enhancing his professional career, the trip was also a great adventure. Joshua was able to visit the Cliffs of Moher in County Clare, Ireland and Giant’s Causeway, in Northern Ireland. PACIV can relocate resources across offices to provide support...

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New Computer System Validation Project @ PACIV Ireland

Recently, PACIV Ireland won a computer system validation project with a large multinational life science company in the Cork area. The project involves the provision of validation remediation support to assist with the successful completion of a large automation project implemented at a biopharmaceutical manufacturing site. The duties will include a range of critical computer system validation related functions such as reviewing operational and computer maintenance SOP documents, preparing system risk assessments and a validation plan, generating OQ documents, SATs and generating RA reports. At PACIV, we ensure with documented evidence, that our automation systems are delivered and implemented meeting their functional intent and that your requirements and approved design are aligned...

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