Month: July 2018

PACIV at ISPE’s ‘Productivity & Innovation in Advanced Pharma Manufacturing’ Conference

Great speakers and insight into the latest trends and technologies in the global pharmaceutical industry. PACIV recently attended the ISPE (International Society of Pharmaceutical Engineering) ‘Productivity & Innovation in Advanced Pharma Manufacturing’ Conference at The Radisson Blu Hotel & Spa in Cork, Ireland with the representation of Brendan Hyland, Business Development Manager and Geraldine Nolan, HR/Administrator Lead (PACIV – Ireland). The conference offered great business development and networking opportunities with our partners in the field. The...

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PACIV at the Corriente Verde Environmental Magazine Fair

Recently, PACIV participated in the Corriente Verde Environmental Magazine Fair. In this event, PACIV had the opportunity to visit and showcase their services to Haemonetics, Stryker and Coopevision plants in Puerto Rico. The Corriente Verde Environmental Magazine Fair is a business tour where companies share their services and other information at the premises of the companies such as Haemonetics, Stryker and Coopevision. The associates that participated in the event were Suliman Rodriguez, Sr. Automation Engineer, and Jaroldi González, Communications Representative II. This expo...

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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...

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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...

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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...

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