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Bigfinite Achieves ISO Certifications: ISO/IEC 27001/27017 for Information Security Management and ISO 9001 for Quality Management

SAN FRANCISCO, CA – (August 26, 2020) – Bigfinite, Inc. (Bigfinite), the leading manufacturing artificial intelligence (AI) and advanced analytics platform company for regulated industries, today announced that it has achieved certification to ISO 9001:2015 in recognition of its commitment to quality management systems (QMS) and ISO/IEC 27001:2013 for information security management (ISMS) including the extension ISO 27017 which includes security in cloud environments. These certifications validate Bigfinite’s ability to deliver reliable systems that align with industry best practices. The certifications were awarded by Lloyd’s Register.

Pere Merino, Chief Operating Officer, Bigfinite, said, “Bigfinite has remained focused on developing Pharma 4.0 technologies in the highly regulated pharma and biotech communities. Acquiring our ISO 9001 and ISO/IEC 27001/27017 certification demonstrates our relentless commitment to bringing technology innovation while upholding the highest quality and security standards.”

The ISO/IEC 27001/27017 is the international standard for activities concerning the management of information security risks and the certification ensures that Bigfinite continuously maintains information security. The ISO 9001 corroborates Bigfinite’s ability to produce consistent, high quality products and experiences for customers. Given the company’s overall focus on regulation and compliance, these certifications are both important milestones for the business.

ISO 9001 and ISO/IEC 27001/27017 are both published by the International Standardization Organization (ISO) and are globally recognized for the qualification of companies’ quality management processes.

About Bigfinite, Inc.

Bigfinite is a software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and pharma 4.0 technologies focused on optimizing pharmaceutical and biotech companies. The Bigfinite analytics platform seamlessly integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites. Bigfinite offers an intuitive way to gain meaningful operational intelligence with data by enabling real-time visibility and predictive insights in a GxP compliant manner with end-to-end data integrity. Founded in 2014, the company is based in San Francisco, California and also has a European office in Barcelona, Spain.

Crystal Black

VP of Marketing

Bigfinite Achieves ISO Certifications: ISO/IEC 27001/27017 for Information Security Management and ISO 9001 for Quality Management

Bigfinite announced that it has achieved certification to ISO 9001:2015 in recognition of its commitment to quality management systems (QMS) and ISO/IEC 27001:2013 for information security management (ISMS) including the extension 27017 which includes security in cloud environments. These certifications validate Bigfinite’s ability to deliver reliable systems that align with industry best practices.
Crystal Black VP of Marketing

The AI World Team and Why it’s Important

At Bigfinite, we are completely aligned with the AI World Team to bring you the best practices and experiences possible where it comes to AI and real information about how it can transform your healthcare initiatives to improve the lives of patients.

JPST Publishes First Study Showing AI Algorithms Can Be Qualified for Regulated Pharmaceutical Manufacturing

Bigfinite announced that a new study, published online in the Parenteral Drug Association’s Journal of Pharmaceutical Science and Technology (PDA JPST), demonstrates that AI algorithms can be qualified for pharmaceutical product and medical device productivity chains. Qualification was achieved using Bigfinite’s GxP-compliant AI software-as-a-service (SaaS) platform.

Bigfinite Announces Additions to Executive Team

Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that Brian Sweeney, Lawrence Baisch and Glenn Griffin have been added to the leadership team.
Crystal Black VP of Marketing

AI Algorithm Qualification

Pharmaceuticals and Biotech companies have no doubt that Artificial Intelligence (AI) is here to stay. Nonetheless, the opportunities AI technology offers are developing at a slow pace in a rather conservative manufacturing industry, aimed at managing production risks under controls that are subject to strong regulations. Fear of change? Risk aversion? Likely not.
Jordi Guitart VP of Artificial Intelligence

Bigfinite Announces Senior Leadership Additions

Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that John Vitalie has been named Chief Executive Officer (CEO) and has been elected to the Board of Directors. David Merino has been named Chief Financial Officer (CFO) of Bigfinite.

Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now

Technological Enhancements with Principal Component Analysis Combined with Artificial Intelligence

Bigfinite Closes Series B Financing with Atlantic Bridge and Honeywell Ventures to Drive Disruption in Manufacturing Analytics

2019 Xavier University AI Summit Reflections – Two Industries Ready for Change

Now that the dust has settled from the Xavier University AI Summit and our team is back to business, we’ve had time to process some of the highlights and key takeaways from the exciting event.  In the past few years, there has been a significant increase in the implementation of digital technologies into various industries that subsequently impacted the way we live, travel, and do business.  From driverless cars to 24/7 customer support chatbots, innovation and technology continue to spiral upward and as we’ve entered the 4th industrial revolution, and healthcare + biopharma should be no exception.  The Xavier University AI Summit is a great event that brings together a range of relevant stakeholders with common focus on artificial intelligence (AI).