Month: August 2018

PACIV at Data Integrity in Packaging Operations Workshop

Recently, Jorge Rodríguez, PACIV’s CEO, presented the “Data Integrity in Packaging Operations Workshop” hosted by the Institute of Packaging Professionals Puerto Rico Chapter at San Juan, Puerto Rico. The presentation discussed how Data Integrity compliance is captured within existing FDA Predicate Rules, how CFR 211.68 (“appropriate controls”) and 21 CFR Part 11 (“Scope & Application”) addressed approximately 95% of the Data Integrity requirements and the more cited topic within the “Data Integrity” related Warning Letters and 483’s is the Computer System Validation...

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PACIV at the 16th PIA Regulatory Conference

PACIV, a PIA Affiliate Member since 2009, was present at the 16th Pharmaceutical Industry Association (PIA) – Food & Drug Administration (FDA) Regulatory Conference held June 21, 2018 at the Sheraton Convention Center in San Juan. Undet the “Innovation for Transformation Leading the Path” slogan, the conference was attended by officials from the U.S. Food and Drug Administration to conduct a program focused on quality metrics, data integrity and risk, control strategies and manufacturing. The event allowed members of the biopharmaceutical and medical devices industries to engage...

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Reduce Your Project’s Delivery Time and Cost with PACIV’s Innovative ISP Service

PACIV has been providing its innovative ISP (Instrumentation Service Provider) Service for several years to a wide range of life science companies and the feedback and results have been impressive. In a nutshell, PACIV’s ISP service takes the hassle and risk involved in procuring and delivering instruments to site away from the project management team by managing this process for them. As project schedules get shorter and shorter due to increased pressure to deliver new pharmaceutical products to international markets quicker, many companies are looking for proven, innovative solutions to help...

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