IT Group

CSV & Data Integrity Gap Assessment

GAMP Group has been offering CSV and Data integrity services since last 8 years.

GAMP Group has Computer System Validation consultants & engineers who can assess your computer systems compliance assessment or validation against following regulatory and industry standards:

• GAMP5 software life cycle development model (V model) and/or
• FDA 21 CFR Part 11 on electronic records, electronic signatures and/or
• PIC/S or EUGMP annex 11 on validated computer systems

GAP analysis is the procedure to manage an organization to not only correct or improve their processes, but also identify processes which are in necessity of upgrade.

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.

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

Key role of GAP analysis:

• 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 GAP analysis benefits organizations in getting comprehensive approach to organization or respective function, this results in decreased project cost.

Data Integrity Gap Assessment

Data Integrity Gap Assessment represents an indispensable tool for properly preparing for an FDA inspection. The Gap Assessment is a systematic process aimed at identifying and analyzing discrepancies between the current state of a system or process and the regulatory requirements or best practice standards. Specifically, in the case of data integrity, this assessment focuses on verifying the completeness, consistency, and accuracy of the data collected and managed by the company.

Why?

Here are some valid reasons why a company should conduct an assessment on its Computerized Systems:

1. Identification of Improvement Areas

   A detailed Gap Assessment allows for the identification of areas where data management processes and systems may not comply with FDA requirements. This enables the company to take corrective measures before the inspection, reducing the risk of non-compliance that could lead to penalties, product withdrawals, or reputational damage.

2. Improvement of Data Quality

   Data integrity is crucial for product quality and patient safety. Identifying and correcting gaps in data management processes helps improve the quality of the data itself, ensuring that it is complete, accurate, protected, and accessible only to authorized personnel.

3. Preparation for FDA Inspection

   An FDA inspection can be a stressful and challenging event for any pharmaceutical company. Being prepared means having confidence in your own data management processes and systems. A properly conducted Gap Assessment helps the company face the inspection with greater serenity, knowing that the main issues have already been identified and resolved.

4. Adaptation to New Regulations

   FDA regulations on Data Integrity are continuously evolving. Regular Gap Assessment allows the company to stay updated on the latest regulatory developments and adjust its processes timely, ensuring ongoing and proactive compliance.

Effective Gap Assessment

Here are the main points where a DI Gap Assessment will be organized to be effective and produce consistent results:

1. Planning

   The first step is to plan the assessment, defining clear objectives, scope, and necessary resources. It is important to involve all stakeholders, including Quality, IT, and Production departments.

2. Data Collection

   Detailed information on current data management processes, including data collection, storage, access, and protection methods, should be collected. This may include interviews with staff, review of documents, and analysis of computer systems.

3. Analysis

   Be sure to analyze the collected data to identify discrepancies relative to FDA regulatory requirements. This may include verifying the completeness of data, accuracy, traceability, and security.

4. Report and Corrective Actions

   A detailed report highlighting identified gaps and recommending specific corrective actions should be prepared. It is essential to establish an action plan with clear timelines and defined responsibilities.

5. Monitoring

   A continuous monitoring system should be implemented to ensure that corrective actions are effective and that data management processes remain compliant over time.

Data Integrity Assessments

We have drawn from international regulations, regulatory guidance documents, FDA Warning Letters, and decades of professional experience to develop comprehensive checklists for assessing policies, procedures, and systems to detect data integrity risks.

Our mission is to provide the information you need to mitigate data integrity risks before your organization has a data integrity issue.

Our Approach to Data Integrity GAP Assessments

Our data integrity consultants follow a consistent, standardized approach to performing data integrity gap assessments to fully encompass the requirements documented by the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA.

Here are the steps we take:

• Meet with you to discuss your industry, products, and markets to determine which of the regulatory guidelines are the most appropriate.
• Discuss any specific areas or concern. For example, you might have known issues due to past audit findings or CAPAs.
• Tailor our standard gap assessment checklist to place the emphasis on the areas of highest risk.
• Conduct the data integrity gap assessment – policies and procedures first, then specific systems and processes. The assessments include demonstrations of system functionality, review of policies and procedures, interviews with subject matter experts, and review of validation documentation.
• Provide a Data Integrity Gap Assessment report identifying the areas of data integrity risk. Each gap is categorized as ‘critical’, ‘major’, or ‘minor’ to aid your prioritization of remediation activities.
• Provide a Report of Recommended Actions for closure of each data integrity risk.
• Facilitate a follow-up meeting with Management and Key Stakeholders to ensure that the risks and recommendations are understood

We can perform data integrity gap assessments either at your site or remotely – whichever fits your needs and budget.