Data Integrity

Data Integrity Risk Assessments

Here are the steps we take:

• Meet to discuss your industry, products, and markets to determine the appropriate regulatory guidelines and any specific areas of concern, e.g., from CAPAs or past audits.
• Tailor our standard assessment checklists to place the emphasis on the areas of highest risk.
• Conduct the data integrity risk 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 Risk Assessment report identifying the areas of data integrity risk. Each risk is categorized as ‘critical’, ‘major’, or ‘minor’ to aid in prioritization of remediation activities.
• Provide a Report of Recommended Actions for closure of each data integrity risk.
• Facilitate follow-up meetings to ensure that the risks and recommendations are understood.

Data Integrity Framework of Policies & Procedures

A robust suite of Policies, Procedures, Work Instructions, and Templates provides the framework to ensure that data integrity is “built-in” from the start. Radiofilum Pharmaceutical ’s experienced data integrity consultants can have a QMS framework ready in a few weeks.

Here are the steps we take:

• Meet to discuss what makes your organization unique, e.g.,
  
  • Industry-specific regulations, e.g., AOPO, CAP, COLA
  • Organization structure, roles, and responsibilities
  • Computer systems and tools already in use
• Tailor Radiofilum Pharmaceutical ’s standard suite of documents, built from US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA data integrity guidelines, to fit your organization.
• Solicit feedback on the preliminary suite of documents and make adaptations before finalizing the Policies, Procedures, Work Instructions, and Templates.
• Develop a Quality Manual to summarize the Policy and Procedure framework and provide an overview for employees, auditors, and inspectors.

Data Integrity Training

Delivering the right level of training at the right time is essential for embedding the principles of data integrity into company culture.

Radiofilum Pharmaceutical has a catalog of Data Integrity training courses that can be provided ‘as is’ or tailored to include examples from your daily operations.

• Short training courses on Data Integrity Principles, suitable for Data Integrity program implementation and annual refresher training
• Longer training courses on advanced Data Integrity topics such as:
  
  • ALCOA in Practice
  • Data Integrity Roles & Responsibilities
  • Data Governance Models
  • Digital Signatures
  • Computer System Validation

Data Governance Programs

A Data Governance program is more than simply determining who ‘owns’ the data.  It’s a program to monitor data integrity practices in real-time and ensure that they continue to mature.

Radiofilum Pharmaceutical’s data integrity consultants will guide you through the steps of implementing a Data Integrity Program that includes:

• A structured program with defined roles and responsibilities for both leaders and subject matter experts
• Processes for real-time monitoring of data integrity health through ongoing review of internal audit findings, metrics, and incident reports
• Processes for prioritizing and initiating course corrections to ensure that issues are not repeated, and data integrity health metrics continue to improve
• Standard process for building a roadmap to improve the organization’s Data Integrity program through strategic investments and targeted process improvements