Discussion of requirements for operational excellence to ensure data integrity. Presentation includes major regulations and key operational requirements for systems that ensure data generated whether in paper or electronic form maintain their integrity and reliability throughout their lifecycle.
Regulatory Agencies have been placing an increased emphasis on enforcement of data integrity. Too often companies have approached this increased enforcement as the regulators are enforcing new regulations and the issues are associated only with the laboratory.
Regulations and guidance - US, EU, MHRA, PIC/s; Regulatory Enforcement – Recent Examples; Infrastructure Requirements ; Pragmatic approaches
All members of quality organizations from VP to front line operations; Members of senior management responsible for establishing and enforcing data integrity policies, procedures and controls.