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 the 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.
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 services for clinical startups and project teams for companies that are expanding their site.
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
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
December 4, 2024
CSV 101: The Basics
Introduction While many organizations have a dedicated Computer System Validation (CSV) team, CSV is never a solo effort. That being said, how do we explain the concepts and basics to those who support CSV, but may not be too familiar with the process? ISPE’s GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems is
November 28, 2024
Computer System Validation: Utilizing a Risk-based Family Approach to Validate Identical Systems
What do we do when we need to validate ten or even twenty of the same computerized system? While it’s technically valid to create unique validation documentation and perform identical testing on each system, this is wildly inefficient from a time and financial perspective. Instead, one can create a risk-based plan to validate a family
November 1, 2024
Design a Secure and Compliant Data Management Architecture in GxP Environments
In GxP environments, such as pharmaceuticals, biotech, and food industries, strict regulatory compliance and data integrity make robust data architecture essential. Here we delve into: effective folder structures, permission management, and user account controls are critical to ensuring security and compliance. Using Active Directory (AD) groups over individual access levels simplifies management, while regular permission
October 8, 2024
Navigating Quality Agreements: Key Considerations for Pharma Suppliers
Quality agreements are vital documents that outline the roles, responsibilities, and expectations between a company and its suppliers. For pharmaceutical companies, ensuring quality throughout the supply chain is crucial for compliance with regulatory requirements and maintaining product integrity. Here are key considerations to include in a quality agreement for suppliers. Introduction/Purpose/Scope 1. Parties to the
October 2, 2024
Maximizing CSV Success: The Vital Role of QA and Team Collaboration
In the pharmaceutical industry, ensuring the quality, reliability, and compliance of computer systems is critical. This is where Computer System Validation (CSV) plays a pivotal role. However, while CSV itself is a structured approach to ensuring systems perform their intended functions, it is the Quality Assurance (QA) team that ensures these validations meet regulatory requirements
September 13, 2024
Understanding User Requirements Specifications (URS) in Computer System Validation
The User Requirements Specification (URS) is a critical document in the Computer System Validation (CSV) lifecycle. A URS defines what a computerized system must achieve to support business-critical functions and comply with regulatory standards. This blog explores the essentials of developing a URS, highlighting its purpose, key components, and best practices. Purpose of a URS
August 28, 2024
Infrastructure that Scales: Strategies for Expanding Companies
Every company experiences periods of either rapid expansion or uncontrolled growth that hinders IT’s ability to keep up with demand or scale fast enough to sustain the business. We can all admit: Change is inevitable and challenging, but with the right forewarning, leadership, and foundational planning; Companies can mitigate issues and build a stable infrastructure
August 9, 2024
Infrastructure Qualification: Ensuring Fit for Use Through Change Control, Testing and Continuous Improvement
Infrastructure qualification is a critical process in ensuring that equipment, systems, and facilities are fit for their intended use in regulated industries, particularly in pharmaceuticals and biotechnology. The process involves rigorous testing, change control, and extensive documentation to meet compliance standards and ensure continuous improvement. This blog will break down the stages of Infrastructure Qualification
July 26, 2024
How to Achieve 21 CFR Part 11 Compliance: A Comprehensive Guide for GxP Systems
21 CFR Part 11 has been in effect for over 25 years, but in an ever-modernizing digital environment, Part 11 compliance is more important than ever. In a nutshell, Part 11 sets forth requirements that GxP electronic records and electronic signatures are required to meet. While the scope of the regulation is not terribly difficult
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