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
August 27, 2025
Use Case: AI-Driven Trending and Adverse Events Data Analysis for Biotech Safety Surveillance
Scenario & Background A mid-sized biotech company developing a novel oncology cell therapy was running multiple Phase II trials across different sites. The company’s internal safety team was overwhelmed by the volume of adverse event (AE) reports and needed support in: However, the client did not want a new IT platform or continuous system integration.
August 20, 2025
Case Study: Meeting Commercial Readiness Deadlines with Multi-Skilled QA and Validation Experts
Client: Mid-sized biotech company developing novel biologics.Industry: Biotechnology / Life SciencesPositions: 2 QA Specialists and 3 Validation Engineers Background A biotech company was advancing a promising therapeutic candidate through clinical studies toward commercialization. To meet FDA submission timelines, validation of their GMP manufacturing and QC lab equipment and systems had to be completed within six
August 11, 2025
Use Case: AI-Powered MBR vs. SOP Contradiction Check
In the biotech industry, the integrity of documentation is just as critical as the product itself. Master Batch Records (MBRs) guide the execution of production steps, while Standard Operating Procedures (SOPs) define how those steps should be performed and documented. These two document types are deeply interconnected, and any misalignment between them can lead to
August 6, 2025
Strategic Staffing in Action: Supporting EU Regulatory Readiness with a Contract CMC Lead
As part of preparing for commercial readiness, a Phase 3 biotech client faced a pivotal challenge: expanding into the European Union while meeting critical regulatory filing and inspection requirements. Their internal regulatory team was well-versed in U.S. requirements but lacked specific expertise in EU Module 3 expectations, centralized procedures, and regional submission strategy. The challenge:
July 30, 2025
Use Case: AI-powered Deviation AnalysisÂ
Scenario: A Biotech Company Analyzing 500+ Deviations to Uncover Trends and Gain Cross-Departmental Clarity A mid-sized biotech company had over 500 deviations logged at a single manufacturing site, spread across multiple departments including Quality, Manufacturing, Engineering, and Supply Chain. The data resided in their existing systems (QMS, Excel exports, reports), and they saw an opportunity
June 19, 2025
Maintaining Compliance: Periodic Review Best Practices for GxP Computer Systems
Whether you’re running a biologics manufacturing plant, managing clinical trial data, or operating a quality management system, your computerized systems play a critical role in ensuring product quality and patient safety. But systems age, users change, processes evolve—and what worked flawlessly two years ago might be a compliance risk today. That’s where periodic reviews come
June 4, 2025
Scaling Up GMP Manufacturing: CSV Strategies for a Growing Biotech Facility
As biotech companies scale from clinical to commercial manufacturing, expansion of GMP facilities brings both exciting growth opportunities and complex regulatory challenges. One area that demands foresight is Computer System Validation (CSV) — the process of ensuring that software systems used in GMP environments are functioning as intended and in compliance with regulations such as
May 28, 2025
Setting Up a GMP Manufacturing Area: CSV Foundations for Biotech
Setting up a GMP-compliant manufacturing site is one of the most critical steps for a biotech company transitioning into clinical or commercial production. In today’s digital landscape, implementing robust Computer System Validation (CSV) practices from the outset is essential—not only to meet regulatory expectations but to ensure seamless, reliable, and compliant operations across your production
May 21, 2025
Scaling Up: CSV Strategies for Growing QC Labs in Biotech
As biotech companies move into clinical trials or commercial readiness, their Quality Control (QC) labs must scale quickly to support expanding operations. But scaling a QC lab isn’t just about acquiring more instruments or running more tests. It’s about validating smarter. Computer System Validation (CSV) becomes increasingly important—and complex—as companies prepare for INDs, BLAs, or
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 14, 2025
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