New White Paper Details Wingspan eTMF Compliance With MHLW ER-ES

January 27, 2016

  • eTMF Resources

In Japan, the Guideline on Control of Computerized Systems in Drug Manufacturing Regulatory Guide provides a number of requirements. It includes detailed guidelines for electromagnetic records and electronic signatures.

Due to the increased interest we have seen in eTMF in Japan, Wingspan has formally reviewed this guidance. Our most recent white paper reviews the MHLW ER-ES guidance and establishes the steps that Wingspan takes to ensure compliance in our eTMF product.