Data Governance Program
In the area of cGMP, regulatory focus on the integrity of electronic and paper-based data has increased sharply. Standalone raw data-generating systems and business processes, as well as interfaced business and production control systems, present a large pool of crucial business information with which data integrity issues can occur. Metrics are one way that an organization can provide assurance to customers, stakeholders, and regulatory authorities that their regulated products are not only safe and effective, but that they are also manufactured utilizing high-quality standards.
Infusion of digitization and associated huge amount of data generation has opened vast amount of information floodgates for the pharma industry and at the same time thrown big challenges of managing data and data integrity. A key aspect of managing data is establishing Data Governance systems. Being regulatory driven industry, this should be part of existing Pharmaceutical Quality Management System. Its become essential for the companies to establish effective and integrated Data Governance program alongwith relevant metrics which can provide assurance to customers, stakeholders, and regulatory authorities that their regulated products are not only safe and effective, but that they are also manufactured utilizing high-quality standards.
Our Data Governance Program helps clients in the following:
- Data Governance Framework
- Process Mapping and Data Inventory
- Data Criticality Identification
- Process Maturity
- Data Integrity Metrics
Our integrated Data Governance Program support clients for
- Establishing Data Governance Framework as subset of existing QMS
- Assessing and identifying areas for enhancements e.g. policies, procedures, trainings
- Establishing processes for data mapping, classification and data lifecycle management as well as disaster recovery management
- Establishing Data Integrity Risk Assessments
- Monitoring and continuous improvement programs, metrics for maturity
Data Integrity Risk Assessment Services for the Pharmaceutical Industry
Ensuring data integrity is a critical aspect of pharmaceutical operations, and conducting thorough data integrity risk assessments is essential to maintain regulatory compliance and safeguard product quality. We offer comprehensive Data Integrity Risk Assessment Services tailored specifically for the pharmaceutical industry. Here's how our services can help your organization:
- Expert Guidance: Our team of experienced professionals specializes in data integrity and regulatory compliance within the pharmaceutical sector. We provide expert guidance throughout the risk assessment process, ensuring that you follow industry best practices and regulatory requirements.
- Comprehensive Assessment: We conduct a thorough assessment of your data management practices, systems, and processes to identify potential areas of risk. This includes an evaluation of data collection, storage, processing, transmission, and archiving methods to ensure compliance with data integrity principles.
- Regulatory Compliance Review: We review your current data integrity practices against relevant regulatory guidelines, such as FDA's Data Integrity and Compliance with CGMP guidance, MHRA's GxP Data Integrity Guidance, and other international regulatory requirements. Our goal is to help you align your practices with these guidelines and mitigate any compliance gaps.
- Risk Identification and Prioritization: We identify and prioritize potential data integrity risks specific to your organization. Our experts analyze factors such as system complexity, criticality of data, data flows, user access controls, and interfaces with external systems to determine the level of risk associated with each area.
- Risk Mitigation Strategies: Based on the identified risks, we develop customized risk mitigation strategies and recommendations tailored to your organization's specific needs. Our experts help you implement appropriate controls, policies, procedures, and training programs to mitigate risks and enhance data integrity.
- Documentation and Reporting: We provide detailed documentation of the risk assessment process, findings, and recommendations. Our comprehensive reports include an overview of the assessed risks, a summary of mitigating controls, and a roadmap for implementing recommended improvements. These reports can be used to demonstrate compliance to regulatory authorities, internal auditors, and other stakeholders.
- Ongoing Support and Training: Our services extend beyond the risk assessment phase. We offer ongoing support and training programs to ensure that your organization maintains a strong data integrity culture. Our experts can provide additional guidance, conduct follow-up assessments, and deliver customized training sessions to reinforce good data integrity practices across your organization.
By leveraging our Data Integrity Risk Assessment Services, you can proactively identify and mitigate data integrity risks, enhance compliance, and protect the integrity and reliability of your pharmaceutical data. Contact us today to learn more about our services and how we can assist your organization in maintaining data integrity excellence in the pharmaceutical industry.
We also assist in creating DI maturity metrics based on GAMP5 Good Practice Guide recommended practices which provides path for continuous process improvements and reduction in data integrity risks.