Assurea serves as the Computer System Validation and Quality Unit for fast growing clients.
Assurea is a woman-owned consulting firm known for quality compliance and computer system validation expertise within global life sciences industry. We have built a model that is collaborative, flexible and accelerates the path forward for our partners to serve patients in need.
Why Assurea?
Choosing Assurea means partnering with a company that is hyper-focused on IT/CSV and Quality. Our services are designed for fast-paced environments. Our pricing structure is transparent and straightforward, and we include built-in project management with every deliverable. We don't offer generalized, cookie-cutter solutions; instead, we take the lead and reduce the burden for our clients.
Our Expertise
Service Lines
We always bring the A-Team! Our team of experts are highly skilled and are at the forefront of trends such as CSA and evolving regulatory guidelines. Our team leads are part of ISPE GAMP steering committee and influence industry best practices. We provide fractional IT/CSV and quality services for clinical startups and turnkey solutions for companies that are setting up their labs.
Contact Us to learn more about our services.
#RootingForYou
Assurea has launched a campaign called #RootingForYou to support and inspire women who drive innovation.
Our Latest Blogs
July 24, 2024
Building a CSV Program in a Time Crunch: Key Steps for Startups and Established Companies
Computer System Validation (CSV) can often feel like a significant speed bump for growing companies looking to transition into the GMP space. It requires resources and considerations that are often not yet taken into account. While this may be more applicable to budding startups, veteran corporations can also find themselves in this situation. In an
July 12, 2024
The Silver Lining: Cybersecurity Breaches in Pharma and Biotech Drive Innovation and Resilience
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
June 12, 2024
Aligning SDLC Processes with GAMP® 5: A Roadmap for Software Providers
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
June 7, 2024
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
May 30, 2024
Network Design for Biotech Sites: Balancing Isolated vs Secure Networking Designs
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
May 22, 2024
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.
May 14, 2024
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
September 7, 2023
Assurea: Founding Member of Women in Advanced Therapies (WIAT)
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.
August 17, 2023
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
July 13, 2023
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.
March 7, 2023
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
November 18, 2022
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
November 14, 2022
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
October 21, 2022
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
September 1, 2022
Assurea’s Tanya Sharma Live with Rizwan Chaudhrey
Tanya Sharma was interviewed by Rizwan Chaudhrey of the RSK Life Science Media in London during Terrapinn’s Advanced Therapies Congress in May 2022 where Assurea participated in the Startup Zone. Rizwan met Tanya Sharma again in September 2022 at the Phacilitate Advanced Therapies UK event and recorded an update on ISPE Women in Pharma and
March 21, 2022
Integrating Data Integrity Requirements into Quality Management Systems
Data integrity translates into the consistency, completeness, and accuracy of data. It is required in all aspects of biopharmaceutical development and manufacturing, including emerging technologies like block chain, as you introduce them into your Quality Management Systems. Consistency, standardization, and traceability are some of the many issues we face when it comes to data integrity. Once
January 4, 2022
ATMPS and Assurea team up to ensure audit readiness for cell and gene therapy innovators
ATMPS Ltd, a UK developer of blockchain-based cell orchestration platforms for advanced therapies is collaborating with US digital compliance consultancy, Assurea, to develop a fully compliant blockchain approach for end-to-end supply chain management of cell and gene therapies. Read the full story here
December 16, 2021
Blockchain in Pharma
Tanya Sharma, Co-Founder of Assurea LLC and Najib Rehman from ATMPS were excited when invited to join Jesse McLaughlin, host of Modern Biopharma Podcast ,to talk about how Blockchain – a new technology that is exploding in our industry – can be used to help us make a jump towards more available therapies for more
September 21, 2021
Why Assurea?
Assurea LLC was launched in June 2020 with the mission of transforming the way we work and turning complexities into innovative solutions.