In life sciences, compliance isn’t just about following rules—it’s about safeguarding patient safety, ensuring product quality, maintaining data integrity, and (yes) ensuring that digital systems can withstand regulatory scrutiny. A crucial tool to ensure compliance is a well-maintained GxP computerized systems inventory.
Organizations risk regulatory findings, audit failures, and costly delays (apart from the potential impact to patients or products) when such lists are not available. In this article, we explore why having a controlled and reliable computerized systems inventory is essential, describe some of the potential problems when it is ineffective, and the long term organizational benefits of an appropriate solution.
A computerized system inventory is a repository that should track all digital systems used in GxP-regulated activities. These systems could include for example Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS),Chromatography Data Systems (CDS), Programmable Logical Controllers (PLCs) and Enterprise Resource Planning (ERP) solutions (and there are many more). Ideally the inventory should include critical metadata such as the system owner, location/site, validated status, location of validation documentation, and system compliance history.
For life sciences companies, this inventory is a crucial component for ensuring compliance with regulations like 21 CFR Part 11 (for the U.S.) and EudraLex Volume 4 Annex 11 (for the EU). Both regulations require companies to manage their computerized systems effectively ensuring integrity of these systems, their data and records and any electronic signatures to be executed in these systems. A comprehensive and accurate inventory is a cornerstone of that compliance.
Looking to predicate rules, overarching GMP regulations in Europe and even the latest October 2024 FDA Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Guidance for Industry (https://www.fda.gov/media/166215/download) there is a clear need for system inventory management in order to achieve the following requirements:
"Electronic systems should be validated prior to use in an investigation using a risk-based approach. Changes to electronic systems (including software upgrades, security and performance patches, equipment or component replacements, and new instrumentation) should be evaluated and validated throughout the life cycle of the system depending on risk."
Under 21 CFR Part 11 and EudraLex Volume 4 Annex 11, computerized systems used in the manufacturing and management of drug products must meet stringent requirements. These regulations emphasize data integrity, requiring systems to maintain accurate and complete records, have appropriate security and controlled access to records and data, and ensure audit trails are properly managed. A computerized system inventory helps life sciences companies to comply with these guidelines by ensuring all systems are tracked, properly validated and that the systems' status and fitness for purpose is clearly understood at any point in time.
Without an accurate inventory, companies risk falling short of regulatory requirements, which can lead to serious consequences, including regulatory findings related to:
21 CFR 11.10 (e), 21 CFR 211.68 (b)
Annex 11, Section 4.3
and more worryingly, increased risk of data integrity issues, leading to patient safety risks. Fines, penalties, or delayed product releases due to non-compliance may also occur.
Historically, many life sciences companies have manually managed their computerized systems inventory, often populating MS Excel workbooks or MS SharePoint in a sporadic manner. While these tools may work at a small scale, they often become unwieldy as organizations grow and their digital inventory expands.
Excel or SharePoint system inventories are often prone to human error, version control issues, and can quickly become outdated if not properly maintained. As a result, they create inefficiencies, especially when systems require periodic reviews or audits. Moreover, such tools are difficult to scale and may lack critical features like automatic notifications for required reviews or built-in audit trails to detect changes to data or records.
As regulatory demands and digital systems evolve, traditional methods and tools may fall short due to a lack of scalability, control, and proper security measures, making it crucial to adopt more purpose built tools for effectively managing computerized systems inventories.
Here are the top 10 issues that may arise from a poorly managed computerized systems inventory:
Out of date Inventory – Outdated systems inventory data with missing or miscategorized systems can lead to misinformed decision-making and increased risk.
Insufficient Data Management and Recovery – Inadequate backups, restoration plans, and data archiving can lead to potential data loss or prolonged downtime in critical systems.
Validated Status Not Clearly Understood – Without a clear validation record, systems may be used improperly, risking non-compliance.
Insufficient Periodic Reviews – Infrequent or insufficient reviews of system status can lead to compliance gaps and audit findings.
Regulatory Findings – Failure to comply with 21 CFR 11.1 (e) or Annex 11 4.3 can lead to costly regulatory inspection findings.
Internal or Customer Audit Findings – Missing periodic reviews or non compliance with internal procedures for inventory management can trigger negative audit results.
Delays in Audit Readiness – Disorganized inventories make it difficult to respond quickly and accurately during regulatory audits.
Incorrect System Metadata – Incorrect or outdated metadata can create confusion about system status or ownership.
Difficulty Locating Validation Documentation – If validation documents are scattered or improperly filed, it can be nearly impossible to retrieve them during audits.
System/Business Owners Not Updated – Lack of clarity in system ownership and responsibilities can result in neglected updates or reviews.
These problems can cause significant operational and compliance risks, but they are entirely avoidable with the right solution in place.
Implementing an effective computerized systems inventory offers numerous benefits:
Risk Management: An effective risk-based approach benefits from a comprehensive system inventory ensuring that systems critical to patient safety and product quality are prioritized. By mapping out your entire ecosystem of systems, you can pinpoint exactly where patient safety and product quality are most vulnerable
Automation: Modern solutions provide automated reminders for periodic reviews, real-time status updates, and built-in audit trails, significantly reducing the burden on IT and quality teams.
Data Integrity: With a centralized inventory system, companies can help to maintain ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete) attributes for data integrity, a key focus of both 21 CFR Part 11 and Annex 11.
Compliance: A well-maintained inventory ensures compliance with regulatory expectations and best practices such as GAMP 5 (Good Automated Manufacturing Practices), helping avoid regulatory and audit findings.
Audit Readiness: A real-time inventory ensures that system data, validation status, and audit trails are always up-to-date, making audits quicker and less stressful.
In today’s fast-paced, highly regulated life sciences environment, the ability to manage and maintain a comprehensive computerized systems inventory is essential for GxP compliance, data integrity, and audit readiness. By moving away from outdated methods like Excel and adopting a purpose built inventory solution, companies can avoid regulatory issues, streamline operations, and focus on delivering safe, effective products to the market.
Don’t wait until it’s too late—sign up for a demo of our Phanero computerized systems inventory solution today and take the first step toward ensuring compliance and operational excellence.