Assurea serves as the IT/Computer System Validation unit for fast growing clients.
Assurea is a woman-owned digital compliance consulting firm known for IT/CSV, software assurance, and AI-driven compliance solutions within the global life sciences industry. We serve startups, large-scale projects and software providers.
With 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
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 Validation
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
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.