Assurea serves as the IT/Computer System Validation unit for fast growing clients.
🚀 We are Assurea—a women-owned digital compliance consulting firm specializing in IT/CSV services, software assurance, and custom AI solutions. Our consulting model is built around what our clients actually need—no fluff, just real solutions. We serve startups, large-scale projects, and software providers.
🔍Forward-Looking: As Assurea grows, we are committed to expanding our global impact in STEM— solving problems and creating waves for positive change. 🌍✨
 At Assurea, We Drive Results!
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We always bring the A-Team! Assurea provides fractional services for clinical startups, supports large-scale IT/CSV projects, and helps software providers with certification preparation to meet regulatory standards.
Our team of experts is highly skilled and part of the ISPE GAMP Steering Committee, contributing to industry best practices.
Why Assurea?
Choosing Assurea means partnering with a company that is hyper-focused on digital compliance. 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.
#RootingForYou
Assurea has launched a campaign called #RootingForYou to support and inspire women who drive innovation.
Our Latest Blogs
May 14, 2025
Setting Up a GMP-Compliant QC Lab: CSV Foundations for Biotech Startups
Launching a biotech company is an exciting journey, especially when it’s time to build your first GMP-compliant Quality Control (QC) lab. Amid the rush to select instruments, hire scientists, and finalize test methods, one foundational piece often gets overlooked—Computer System Validation (CSV). Whether you’re preparing for your first IND or simply trying to get your
April 23, 2025
Thinking About an Asset Management System in Biotech? Here’s What to Know About Validation
Bringing an asset management system into a biotech environment isn’t just about picking the right tool—it’s about ensuring that tool is validated, compliant, and meets both regulatory and business needs. Whether you’re handling equipment calibrations, managing work orders, or ensuring traceable maintenance histories, Computer System Validation (CSV) is a critical step. Here’s what you need
April 13, 2025
What to Consider for MES Validation: Practical CSV Insights
Digitizing manufacturing with an MES is a big step, especially in regulated spaces like pharma and biotech. But alongside innovation comes responsibility—especially when it comes to compliance. Since MES sits at the heart of production, enforcing process controls and managing real-time data, it’s essential to validate the system to ensure it performs reliably, consistently, and
April 9, 2025
Considerations for Biotech Companies Evaluating GxP Software Providers
As biotech companies scale, user-friendly software systems—like EQMS, LIMS, or MES— can help standardize operations, ensure data integrity, and support regulatory compliance. But before signing a contract, it’s critical to better understand what the system can do and how it’s built, maintained, and supported behind the scenes. So, how do you dive into what really
March 27, 2025
Key Considerations for Selecting an eQMS in Biotech
In the biotech industry, regulatory compliance, data integrity, and operational efficiency are more than just priorities—they are critical to the success of any organization. As biotech companies move from paper-based quality management systems to Electronic Quality Management Systems (eQMS), it’s crucial that they select a system that is not only compliant but also scalable and
March 15, 2025
Learning Management Systems in Biotech: Key CSV Considerations
Implementing a Learning Management System (LMS) in the biotech industry requires careful consideration of Computer System Validation (CSV) principles. In the biotech sector, LMS platforms are often used to deliver and manage GxP training, ensuring employees are compliant with regulatory requirements such as FDA’s 21 CFR Part 11 and EU Annex 11. Here’s what to
February 17, 2025
Data Integrity in GxP Systems: Why It Matters and How to Get It Right
Data integrity remains a critical focal point for regulatory agencies overseeing the pharmaceutical and biotechnology industries. Ensuring data integrity is not merely a compliance requirement; it’s fundamental to patient safety, product quality, and operational efficiency. This article explores the significance of data integrity in Good Practice (GxP) systems, common challenges organizations face, and best practices
February 12, 2025
Best Practices for LIMS Implementation and Validation
In the evolving world of laboratories and data-driven decision-making, Laboratory Information Management Systems (LIMS) have become indispensable. These systems streamline sample tracking, data analysis, reporting, and compliance, ensuring smooth operations. However, implementing a LIMS isn’t just about choosing the right software—it’s about ensuring the system meets regulatory, operational, and quality standards through Computer System Validation
January 28, 2025
Computerized System Validation: How to Create Effective Validation Plans and Reports
Computerized systems, within the pharma and biotech industry, must be reliable, secure, and fully compliant with industry regulations and that’s where Computerized System Validation (CSV) comes in! It ensures that these systems function as intended, maintain data integrity, and meet regulatory requirements. The Validation Plan (VP) and the Validation Summary Report (VSR) are two key
January 22, 2025
Design and Configuration Specification: Key Considerations in CSV Lifecycle
Computer System Validation (CSV) ensures that computerized systems comply with regulatory requirements, safeguarding patient safety, data integrity, and product quality. Two critical documents in the CSV lifecycle are the Design Specification (DS) and the Configuration Specification (CS). These documents are instrumental in establishing how systems are developed, implemented, and maintained to meet both user and
January 7, 2025
Understanding Functional Requirements Specifications (FRS) in Computer System ValidationÂ
A well-crafted Functional Requirements Specification (FRS) is a crucial component of the Computerized System Validation (CSV) process in regulated industries. This document outlines the specific functionalities and requirements that a system must meet to satisfy user needs and regulatory compliance. Let’s explore what makes a great FRS and how to approach its development. Purpose of
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