In the pharmaceutical industry, the validation of computerized systems is a regulatory requirement, not an optional best practice. Every system with an impact on the GxP environment — Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice — must comply with applicable quality standards and be properly documented. Without this, audits become complicated, data integrity is at risk, and the traceability of critical processes loses its foundation.
The starting point of any computerized systems validation program is the inventory. Without a complete and up-to-date inventory, it is impossible to know which systems require validation, which are already validated, which need revision, and which might generate vulnerabilities during a regulatory inspection.
This article describes the structured process for building that inventory, with GxP impact assessment criteria and GAMP categorization as the methodological framework.
What Is a GxP-Impacting Computerized System?
A computerized system is defined as the set that includes hardware, software, network components, controlled functions, involved personnel, and associated documentation.
A GxP computerized system is one subject to good practice regulations — GMP, GLP, GDP, or others applicable in the pharmaceutical and life sciences industry. The key is not the technological nature of the system, but its level of involvement in regulated activities: manufacturing, quality control, clinical studies, distribution.
The range of systems that may have GxP impact is broad: quality management systems (QMS), laboratory information management systems (LIMS), manufacturing execution systems (MES), enterprise resource planning systems (ERP), clinical data management platforms, among others.
The Computerized Systems Inventory: What It Must Contain and Why It Matters
The inventory is the documented record that every regulated company must maintain on its GxP-impacting computerized systems. Its function is to centralize critical information about each system in a format that supports efficient management, regulatory compliance, and maintenance planning.
A well-built inventory includes for each system:
- Current validation status.
- System owner or responsible party.
- GxP impact level.
- Version in use.
- Supplier or developer.
- Assigned GAMP category.
The goal is not to document each individual hardware component, but to manage information at the system level, avoiding duplication and ensuring the information is at the appropriate level of detail to support audits and internal evaluations.
Process for Preparing the Inventory: Six Steps
Step 1 — Identification of Computerized Systems
Conduct an exhaustive mapping of the company’s processes and areas to identify all computerized systems in use. This mapping must cover all areas with regulated activity, including production, quality control, quality management, storage, distribution, and clinical studies.
Step 2 — GxP Impact Assessment (Step A)
The GxP impact assessment consists of an initial risk evaluation to determine whether a system has an impact on patient safety, product quality, or data integrity. The following questionnaire serves as a guide:
N° | Question |
|---|---|
1 | Does the Computerized System (CS) directly or indirectly control or monitor product quality? |
2 | Does the CS affect product registration, e.g., Drug Master File, Dossier, etc.? |
3 | Does the CS generate, manage, calculate, or store GxP-relevant data covered by regulations such as 21 CFR Part 11, Annex 11 EU-GMP, or others? Does it use electronic signatures? |
4 | Does the CS indicate materials to be used (e.g., raw materials, packaging materials, formulated products, clinical trial materials, etc.)? |
5 | Is it used for RECALL, stock traceability, or product history? |
6 | Does the CS maintain information on stock, product status, location, or shelf life? |
7 | Are data from the CS used to support product release? |
8 | Is it related to reconciliation, partial component usage, or split batches? |
9 | Is it related to labeling, coding materials, final products, or packaging components (e.g., identification labels)? |
10 | Does the CS affect or impact product quality (purity, potency, sterility, efficacy)? |
11 | Is the CS used to manage qualification data of personnel working in production, warehouse (GMP-related), or quality control? |
12 | Does the CS supervise or control the distribution, storage, or transport of products or their environmental conditions? |
13 | Does the CS influence the maintenance and calibration of equipment (managing orders, certificates, test planning, limits, etc.)? |
14 | Does the CS generate, manage, or store documents such as SOPs? |
If at least one answer is YES, the system has GxP impact. From there, the level of impact is determined:
- High: if the system has a direct impact on product quality, patient safety, or data integrity. Includes systems that generate or control data for product release, recall management, pharmacovigilance, or adverse event records.
- Medium: if the system has a direct impact on regulations, but not on product quality, patient safety, or data integrity.
- Low: if the system has an indirect impact on product quality, patient safety, or data integrity.
Step 3 — Software Complexity Evaluation: GAMP Categorization (Step B)
GAMP categorization classifies software and hardware components based on risk, which increases as one moves from standard to highly customized software. The main categories are:
- Category 1 — Infrastructure software: operating systems (Windows, MacOS, Linux), database engines (SQL, Oracle), programming languages, desktop applications (Excel, Word), antivirus.
- Category 3 — Non-configured systems: commercial off-the-shelf software that is non-configurable, or configurable but used in standard mode without specific parameterization. Includes statistical calculation software and non-parameterizable data acquisition systems.
- Category 4 — Configured systems: standard systems with configurable functionalities adapted to the user area’s processes. Includes LIMS, MES, ERP, and widely recognized industry systems. A Category 3 system that is configured at any point in its lifecycle must be reclassified as Category 4.
- Category 5 — Customized systems: internal or external custom developments, or standard systems with additional custom developments. These represent the highest risk level and require the most comprehensive documentation.
Step 4 — General System Impact Evaluation
The total evaluation combines the result of Step A (GxP impact) and Step B (GAMP complexity) to determine the system’s risk class using a predefined risk matrix:
- Class 1: High Risk.
- Class 2: Medium Risk.
- Class 3: Low Risk.
The resulting risk level determines the formality and level of documentation required in subsequent validation stages.
Step 5 — Documentation and Inventory Management
With the collected information, the formal inventory record is built. Documentation must follow a standardized format that includes all relevant sections for each system. Additionally, a periodic review and update schedule must be established: any changes to systems or their attributes must be promptly reflected in the inventory.
Using electronic management tools facilitates continuous updating and access during audits.
Step 6 — Communication and Training
The inventory loses value if the personnel involved in systems management do not understand its importance or know how to maintain it. Training all responsible parties is part of the process, not an optional step.
Conclusion
A documented and up-to-date computerized systems inventory is the operational foundation of any validation program in regulated pharmaceutical environments. It provides effective control over the systems supporting business processes, sustains regulatory compliance during FDA, EMA, or ANVISA inspections, and facilitates strategic planning for maintenance and periodic reviews.
Implementing or reviewing the computerized systems inventory is not a one-time task. It is a continuous process that requires documentary discipline and permanent updating to maintain its value as a control tool and evidence for auditors.
