Challenge: IDMP. Solution: qSync By Mareana.
Completing hundreds of fields of information for up to thousands of products can challenge even the most experienced pharmaceutical manufacturing compliance lead, which is why Mareana originally created qSync. Here are just a few of the benefits of using qSync by Mareana for IDMP compliance:
Reduces the level of resources required for IDMP compliance
Saves countless hours of tedious and error-prone manual labor
Increases data accuracy, reduces costs, and accelerates the entire compliance process
qSYNC JUMP STARTS IDMP COMPLIANCE:
qSync accesses 52 of the first 79 required IDMP fields from publicly-available information. So your IDMP project begins with the majority of the first level work completed.
The remaining fields are then pulled either from in-house documentation, databases, or any format in which the data may be trapped.
Minimal impact on compliance staff
IDMP Information and Resources
Beginning in 2017, organizations that market or manufacture medicinal products in the European Union will be required to comply with the Identification of Medicinal Products (IDMP)—a set of guidelines that specify uniform identification criteria for every medicinal product being sold or manufactured in the EU. These criteria include 178 descriptor fields covering product name, strength, packaging, method of administration, and many other identifiers.
Although IDMP can be seen as an executional burden, it can also be a catalyst for more robust data management, resulting in improved data visibility, meaningful analytics, and reduction of the costs associated with poor data quality.
Below we’ve assembled a library of resources around compliance, deadlines, opportunities, and other related topics.
Official IDMP document from the EMA
Life Science Leader article, summarizing IDMP requirements
PharmTech: the growing popularity of regulatory outsourcing
PharmExec.com Q & A with Andrew Marr about IDMP compliance, challenges, timing, and potential U.S. impact
PharmTech: article on how IDMP is serving as a catalyst for data management transformations inside pharmaceutical companies