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30May

Network Design for Biotech Sites: Balancing Isolated vs Secure Networking Designs

May 30, 2024by David Beachin Information Technology

Network design has always played a critical role in ensuring seamless operations in Biotech. However data security and reliable communication are often at odds with each other. Sites, which include laboratories, research facilities, and manufacturing plants, demand specialized network infrastructures to support their research, maintain sensitive data, and a myriad of sophisticated manufacturing equipment. This

Understanding GxP and ERES Requirements Applicability for Computer Systems

May 22, 2024by assureallcin Computer System Validation

For FDA-regulated pharma and biotech companies, computer systems used in GxP environments must adhere to Electronic Records and Electronic Signatures (ERES) requirements, as governed by FDA 21 CFR Part 11 to ensure data integrity, product quality, and patient safety. Computer systems that create, modify, maintain, archive, retrieve, or transmit records required by GxP regulations (e.g.

Supplier Management Program for a Clinical Biotech Startup

May 14, 2024by assureallcin Quality Compliance

As a clinical startup, establishing a supplier management program and managing supplier relationships is critical to ensuring the quality, safety, and efficacy of clinical products and therapies. A supplier management program defines the standards to evaluate, qualify, monitor, and requalify a company’s suppliers. This program is a holistic approach to ensuring your suppliers meet regulatory

Assurea: Founding Member of Women in Advanced Therapies (WIAT)

September 7, 2023by assureallcin Press

Rizwan Chaudhrey interviews Assurea’s Tanya Sharma, Catapult‘s Fernanda Masri, and Phacilitate‘s Becky Johnson-Kent at WIAT (#ATE2023) to get their perspective on the impact of Women in Advanced Therapies and what learnings they had gained from attending the WIAT event in Portugal.

Building a Biotechnology Business While Helping Women Shine

August 17, 2023by assureallcin Press

Tanya Sharma expressed her views on women in the pharma industry in this detailed article by Bioprocess International. Read more below as she shares the current landscape for women entrepreneurs and the shift needed in the pharma and biotech industry. Women make up a significant percentage of the people who have established careers in the

Cell and Gene Therapy Distributed and Point-of-Care Manufacturing: Building Infrastructure and Capacity

July 13, 2023by assureallcin Information Technology

Hear from our Co-founder, Krisha Patel, and CEO of Cellular Origins, Edwin Stone as they discuss the current challenges in building infrastructure and capacity for cell and gene therapy in this panel hosted by Carol Houts, CSO at Germfree. ? ? Key Discussions:? The use of automation tools and robotic solutions that support scale-up activities.

From Start-up to Staple: RegMedNet Interviews Tanya Sharma

March 7, 2023by assureallcin Press

To celebrate International Women’s Day (8 March) and acknowledge the often challenging career path taken by women in science, RegMedNet spoke to Tanya Sharma, co-founder of Assurea (NC, USA) about her inspirations as a woman in science, the resources and mentors she draws upon to support her professional journey and how learning from her mentors

Women Leading Validation Podcast: Assurea

November 18, 2022by assureallcin Computer System Validation

Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Assurea’s Co-Founders, Tanya Sharma and Krisha Patel on the Women Leading Validation Podcast. They discuss their entrepreneurial journeys and share the Assurea story. They also share their perspectives on the current challenges and barriers in the biotech industry around digital compliance and the adoption of novel technologies. Listen to

Assurea’s co-founder is on a mission to elevate women in Pharma

November 14, 2022by assureallcin Press

(By Brian Buntz) Tanya Sharma, co-founder of the consulting firm Assurea LLC, helps clients in the life sciences industry navigate regulatory requirements. Sharma is an advocate for women in STEM and the life sciences. Sharma: I came to the U.S. when I was five years old and became interested in biomanufacturing. I worked in the labs

Empowering Women Entrepreneurs: Assurea is ROOTING FOR YOU!

October 21, 2022by assureallcin Press

The article highlights the persistent challenges and disparities faced by women entrepreneurs in the United States, particularly in the biotech and pharmaceutical sectors. Despite women-owned businesses accounting for 40% of US enterprises, women-led startups received only 2.3% of venture capital funding in 2020. This imbalance is further exemplified by the fact that 92% of CEOs

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