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:
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.
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.
Here are some valid reasons why a company should conduct an assessment on its Computerized Systems:
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.
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.
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.
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.
Here are the main points where a DI Gap Assessment will be organized to be effective and produce consistent results:
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.
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.
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.
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.
A continuous monitoring system should be implemented to ensure that corrective actions are effective and that data management processes remain compliant over time.
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 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:
We can perform data integrity gap assessments either at your site or remotely – whichever fits your needs and budget.