Follow these best practices from industry leaders to ensure your IDMP
compliance program is headed in the right direction.
The clock is ticking on implementing the EMA’s IDMP standard. With the release of EU IG v2.1, the industry is in the final stages of preparing for optional submissions in 2022.
Looking ahead, IDMP readiness will be dependent on the state of a company’s data. Leaders should evaluate data quality, ownership, and governance. Whether you’re just getting started or are already in progress, here are some established best practices from industry leaders to advance your efforts toward IDMP compliance.
Understand technology and procedural landscape
- Take inventory of existing systems and procedures that are unable to meet the requirements of IDMP
- Identify data silos and repositories that need to be updated and connected
Evaluate data readiness and perform remediation
- Establish consistent nomenclature and data definitions
- Plan and execute data remediation projects
- Craft a sustainment plan to ensure that future data meets IDMP requirements
Establish data ownership and accountability
- Develop documentation on data handling for consistency and compliance
- Tie data ownership to functional areas
- Establish a culture of compliance with proper training and accountability for data integrity
Modernize regulatory operations
- Identify and implement a scalable RIM system
- Ensure data repositories are properly linked across the organization
- Digitize RegOps and shift away from manual information repositories and spreadsheets
Learn more: For additional insights on IDMP readiness from industry peers and Veeva experts, visit www.veeva.com/eu/IDMP