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7 Steps to Conduct GAP Assessment for Computerized Systems


GAP is nothing but difference between actual state and desired state.

The aim of GAP assessment in Computer System Validation is to identify the gap between company’s existing procedures, practices and policies with respect to relevant regulatory guidelines and compliance standards. The GAP analysis involves evidence and it lays down the variance between requirements and existing strength.

In Computer System Validation, GAP assessment serves to pinpoint differences between a company’s existing procedures, practices, and policies and relevant regulatory guidelines and compliance standards. It involves gathering evidence to delineate the variance between requirements and current strengths.

A GAP assessment is usually conducted before the validation activity starts. Effective GAP analysis helps maintaining and developing better compliance. 

Conducting a GAP Assessment before commencing validation activities is standard practice. An effective GAP analysis aids in maintaining and enhancing compliance standards, ensuring robust regulatory adherence.

The aim of GAP analysis in Computer System Validation is to identify the gap between company’s existing procedures, practices and policies with respect to relevant regulatory guidelines and compliance standards. The GAP analysis involves evidence and it lays down the variance between requirements and existing strength.
GAP assessment in CSV is to identify the gap between company’s existing procedures, practices and policie.

Key role of GAP Assessment

  • Identify the requirements for computer system/software
  • Identify the risk of computer system/software against the requirements
  • Ensure that required documents and SOPs are available
  • Ensure that the specifications of computer system/software are according to requirements
  • Mitigate the risk of computer system/software against the requirements
  • To verify that computer system/software meets compliance standards

Steps for conducting GAP Assessment

Conducting a GAP Assessment for a computerized system involves identifying where the current system does not meet regulatory, operational, or business requirements and determining what measures are needed to bridge these gaps. Here’s how you can approach this process, using a Laboratory Information Management System (LIMS) as an example:

Assess and address gaps between a computerized system and requirements, using a LIMS as a model.
Assess and address gaps between a computerized system and requirements, using a LIMS as a model.
  • Identify Applicable Regulations: Gather all relevant regulations such as FDA 21 CFR Part 11 for electronic records and signatures, EU Annex 11 for computerized systems, and any applicable industry standards for laboratory operations.
  • Determine Business Needs: Document the specific operational requirements for the LIMS, including data management, sample tracking, report generation, and any unique business processes that the system must support.
  • System Documentation Review: Assess existing system documentation, including user manuals, system specifications, and validation reports to understand the system’s capabilities and limitations.
  • Stakeholder Consultation: Interview key stakeholders from the IT department, laboratory staff, and quality assurance to gather feedback on the system’s performance and any issues faced in daily operations.
  • Based on the scope (reference requirements and evaluated system validation documentation), the evaluation and comparison of both will be performed.
  • A GAP Assessment Report (Annex 2) will be created to compile all identified discrepancies, assign criticality, and impact classification, and indicate suggestions for actions to resolve or mitigate the GAPs.

Compliance Analysis: Compare the current functionalities and features of the LIMS against the regulatory requirements identified in Step 1 to spot any compliance gaps, such as missing audit trail functionalities or insufficient electronic signature capabilities.

Operational Analysis: Evaluate the system against the business needs compiled to identify any operational deficiencies, such as lack of integration with other lab equipment or inadequate reporting tools.

Critical Gap: Demands substantial financial investment or significant alterations to the quality system.

Significant Gap: Implies no need for financial investment but calls for substantial adjustments to the quality system or documentation.

Minor Gap: Doesn’t necessitate financial investment; only updates to documentation or minor adjustments to testing are required.

Validation Gap: Indicates inadequate or non-existent validation procedures.

  • Prioritize Identified Gaps: Use a risk-based approach to prioritize the gaps based on their potential impact on data integrity, product quality, safety, and regulatory compliance. Consider factors like the likelihood of occurrence and severity of impact.
  • Documentation: Document each gap along with its associated risks and prioritization to facilitate targeted action planning.
  • Mitigation Strategies: For each high-priority gap, develop a detailed plan outlining corrective actions, such as software updates, configuration changes, or process modifications.
  • Assign Responsibilities: Designate team members responsible for implementing each part of the action plan, ensuring clear accountability.
  • Timeline and Budget: Establish a timeline for the completion of each action item and estimate the required budget, considering resources like software, training, and potential downtime.

        –   Recognize performance gaps within each category.

        –   Identify gaps and corresponding practices with respect to standards.

        –   Analyze logical relationships and among practices.

        –   Formulate an action plan and obtain consensus.

  • Execute the Plan: Implement the action plan according to the established timeline, ensuring that each step is executed in compliance with the relevant SOPs and documentation requirements.
  • Monitor and Validate: Continuously monitor the system post-implementation to ensure the gaps have been effectively addressed. Conduct validation activities as necessary to confirm that the system now meets both regulatory and business requirements.
  • Feedback Loop: Establish a feedback mechanism to capture ongoing user and stakeholder feedback on the system’s performance and usability.
  • Periodic Review: Schedule regular reviews of the LIMS to ensure it remains in compliance with evolving regulatory requirements and adapts to changing business needs.

10 Nos of essential documents for GAP Assessment

System Specifications: Detailed documentation on the system’s intended use, capabilities, limitations, and configurations.

Configuration Records: Records of the system’s setup, including any customizations or configurations tailored to specific operational needs.

  • Validation Plan: A document outlining the strategy, scope, and standards for the system’s validation.
  • Installation Qualification (IQ) Reports: Documentation verifying the system was installed according to the manufacturer’s specifications.
  • Operational Qualification (OQ) Reports: Documentation ensuring the system operates according to predefined criteria in the selected environment.
  • Performance Qualification (PQ) Reports: Confirmation that the system performs as expected under actual operational conditions.

Detailed procedures covering all aspects of the LIMS operation, including but not limited to:

  • Data entry and management
  • Sample tracking
  • Reporting
  • System maintenance and backup
  • Handling of deviations and exceptions

Documentation of training provided to users, including training materials, attendee lists, and assessments of training effectiveness.

Documentation of all changes made to the system after initial validation, including software updates, hardware changes, and adjustments to system configurations or functionalities.

Records demonstrating the system’s capabilities for tracking and logging user actions, ensuring the integrity of data managed within the LIMS.

Policies and records detailing user access levels, authentication mechanisms, and measures implemented to protect sensitive information

Support and Maintenance Agreements: Documents outlining the terms of support and maintenance services provided by the LIMS vendor.

Software Update Records: Documentation of all software updates applied to the system, including details of the update, the reason for the update, and the impact assessment.

Documents related to risk assessments performed on the LIMS, including methodologies used for risk identification, analysis, and control.

Any documentation that demonstrates compliance with relevant regulatory requirements and guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and ISO/IEC 17025, if applicable.

Collecting and reviewing these documents will provide a solid foundation for assessing the current state of an installed LIMS against regulatory requirements and business needs. The GAP Assessment can then identify areas for improvement, ensuring the system is fully compliant and optimized for operational efficiency.

Real-Time Example: GAP Assessment

Let’s consider a scenario where a pharmaceutical company conducts a GAP Assessment of their LIMS system. During the evaluation, it’s found that the LIMS does not have an adequate audit trail feature for tracking changes to critical data, a requirement under FDA 21 CFR Part 11 for ensuring data integrity. Additionally, stakeholders report that the current LIMS lacks an integrated inventory management feature, crucial for efficient lab operations.

Gap Identification:
  • Compliance Gap: Inadequate audit trail functionality.
  • Operational Gap: No integrated inventory management feature.
Action Plan:
  • For the compliance gap, the action plan includes upgrading the LIMS software to a version that offers enhanced audit trail capabilities, ensuring that every data entry, modification, or deletion is properly recorded and attributable.
  • To address the operational gap, the plan involves evaluating third-party inventory management modules that can be integrated with the existing LIMS, thereby streamlining lab operations and reducing manual inventory tracking errors.
  • Implementing these measures not only ensures regulatory compliance but also enhances operational efficiency. A GAP Assessment, thus, serves as a crucial tool in maintaining the integrity, compliance, and effectiveness of computerized systems like LIMS.

Need help with GAP Assessment Activities

Strategy to handle Gaps

If the potential GAPs have been confirmed, we recommend the following activities:

Handling gaps identified during a GAP Assessment involves a structured approach that prioritizes issues based on their risk to compliance, operational efficiency, and data integrity. The process ensures that each gap is adequately addressed through corrective actions, validation, and continuous monitoring. Here’s how to manage the process

Documentation: Ensure each identified gap is thoroughly documented, including details about the gap’s nature, its potential impact, and the circumstances under which it was identified.

Categorization: Categorize gaps based on their relevance to regulatory compliance, system functionality, data integrity, and operational efficiency. This helps in prioritizing efforts and resources.

Risk Analysis: Perform a risk analysis for each identified gap to evaluate its potential impact on product quality, patient safety, regulatory compliance, and business operations.

Prioritization: Prioritize the gaps based on the risk assessment, focusing first on those that pose the highest risk.

Mitigation Strategies: For each high-priority gap, develop a detailed corrective action plan. This plan should specify the steps needed to address the gap, including system modifications, process changes, additional training, or updates to documentation.

Responsibilities and Timelines: Assign clear responsibilities for implementing each action and establish realistic timelines for completion.

Execution: Implement the corrective actions according to the plan, ensuring compliance with relevant SOPs and validation protocols.

Documentation: Document the implementation process, including details of the actions taken, individuals involved, and the dates of implementation.

Validation: For changes that affect system functionality or performance, conduct a re-validation to ensure the system still meets all specified requirements and regulatory standards.

Verification: Verify that the corrective actions have effectively addressed the gaps and that no new issues have been introduced.

Monitoring: Establish a monitoring plan to ensure the effectiveness of the corrective actions over time and to identify any recurrence of the gaps or emergence of new issues.

Continuous Improvement: Integrate the lessons learned from addressing the gaps into continuous improvement processes for the system and the overall quality management system.

Sagar Pawar

Sagar Pawar

Computer System Validation Specialist