Partner with Compliance Architects to strengthen your data integrity.
For life science companies, a fundamental principle of data and information management is adherence to data integrity principles. Best summarized by the acronym ALCOA – attributable, legible, contemporaneous, original and accurate (also referred to at times as ALCOA+) – data integrity is a baseline expectation for FDA-regulated companies and life sciences companies in general. Maintaining data integrity is more critical than ever. Not just FDA, but other global regulatory bodies such as EMA, ANVISA, CFDA, MHRA and others have intensified their focus on data integrity – and for very good reason. For all regulators – and FDA in particular – data integrity is the foundation upon which they can trust the information they receive, and observe, from product submissions and during inspections. For FDA and other regulators, when considering companies operating in industries such as pharmaceuticals, biotechnology, and medical devices, ensuring data integrity isn’t just about compliance; it’s about safeguarding public health and safety! As a result, data integrity is a primary job of all companies trying to protect patient health and safety, maintain regulatory trust, and reduce risk to your business operations and market access. Compliance Architects® offers comprehensive data integrity services – including specific data integrity assessments and remediation services – designed to help your organization meet a wide variety of regulatory expectations and build a culture of data integrity.
Data integrity can best be described as a comprehensive set of systems, processes, procedures, and practices that, in the aggregate, results in a company’s data being ALCOA: attributable, legible, contemporaneous, original and accurate. Data integrity is a lifecycle principle – meaning – the principles are applied throughout the lifecycle of data or information – from creation to destruction (if any). For regulated industries, this means ensuring that all records—whether electronic or paper-based—are developed with controls, managed with controls, migrated forward with controls, repurposed with controls, and archived or deleted with controls. Failure to control data and information throughout its lifecycle can result in FDA 483s, warning letters, failure to approve submissions, clinical study data rejections, failure of PAIs, import bans, product recalls, and even facility closures. Beyond regulatory consequences, lapses in data integrity can erode trust and damage your brand.
Compliance Architects is an expert in development and deployment of the complicated systems and practices necessary to ensure data integrity across diverse systems, processes, and teams. To ensure data integrity in life sciences companies, it is necessary to take a multi-dimensional approach to assessing your current practices and developing and delivering customized solutions that meet both regulatory requirements and your operational needs.
1. Data Integrity Gap Assessments
We begin by conducting a thorough review of your organization’s data governance practices, systems, and processes. This assessment identifies vulnerabilities and gaps that could expose your company to regulatory risks. Our expert team evaluates key areas, including:
2. Remediation Strategy Development
Once we identify gaps we focus on systems and practices that can yield the biggest risk reduction returns in the shortest amount of time. We prioritize findings and group them into logical buckets for program management and remediation. Then, we collaborate with your team to develop a tailored remediation plan. This plan prioritizes critical issues, ensuring swift action to mitigate risks while planning long-term improvements to your data integrity framework. Our remediation plans often include:
3. Implementation Support
Effective remediation requires more than a plan—it demands execution. Our team works alongside your internal staff to implement the recommended changes, ensuring seamless integration with your existing systems and processes. Whether it’s upgrading software, revising workflows, or enhancing staff capabilities, we’re there every step of the way.
4. Validation and Testing
After remediation, we perform rigorous validation and testing to ensure the changes meet regulatory standards. Our team utilizes proven methodologies to verify that your systems are functioning as intended and that your data is secure, accurate, and compliant.
5. Ongoing Monitoring and Maintenance
Data integrity isn’t a one-time effort; it requires continuous vigilance. Compliance Architects provides ongoing monitoring and support to help your organization sustain compliance. Our services include periodic audits, risk assessments, and refresher training sessions to keep your team prepared for future regulatory inspections.
Compliance Architects is your trusted partner for achieving and maintaining data integrity across your organization. Our comprehensive assessments, remediation services, and ongoing support ensure your organization is prepared to meet the challenges of today’s aggressive data-focused regulators.
Contact us today to schedule a consultation and learn how our data integrity assessments and remediation services can safeguard your operations, enhance regulatory compliance, and build a strong foundation for future success.
Let Compliance Architects simulate the pressure of a real FDA inspection—so your team can learn, improve, and be ready when it counts.
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