New Blog – Page 2 – AssureaLLC

The Silver Lining: Cybersecurity Breaches in Pharma and Biotech Drive Innovation and Resilience

July 12, 2024by David Beachin Information Technology

Since the first major pharmaceutical breach reported in 2017 by Merck Sharp and Dohme, cyber attackers have increasingly targeted the biotech and pharmaceutical sectors. The strict regulatory compliance required in these industries creates complex digital environments, making them attractive and vulnerable targets for cyberattacks. Within a few years after the COVID-19 Pandemic, where digital transformation

Aligning SDLC Processes with GAMP® 5: A Roadmap for Software Providers

June 12, 2024by Jayvee Mamuyacin Computer System Validation

In software development for regulated industries, ensuring compliance with regulations such as 21 CFR Part 11 and EU Annex 11 requires a systematic and structured approach. In this blog, we explore how adhering to the principles of ISPE GAMP® 5, can guide software providers in aligning their activities to ensure compliance. In this blog, let’s

Understanding CSV – Essential Deliverables for System Validation

June 7, 2024by assureallcin Computer 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

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

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