Understanding CSV: Essential Deliverables for System Validation

What is Computer System Validation (CSV)? CSV is a structured process that documents and tests GxP computer systems to ensure they meet predefined specifications and regulatory requirements. This involves rigorous testing and documentation to demonstrate that systems are installed correctly, operate as expected, and produce reliable results. For biotech and pharma companies, CSV is crucial

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Understanding GxP and ERES Requirements Applicability for Computer Systems

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.

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Building a Supplier Management Program for a Clinical Biotech Startup

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

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Building a Biotechnology Business While Helping Women Shine

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

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

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. Technologies that

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From Start-up to Staple: RegMedNet Interviews Tanya Sharma

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

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Women Leading Validation Podcast: Assurea

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

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

(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

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Empowering Women Entrepreneurs: Assurea is ROOTING FOR YOU!

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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