FDA 21 CFR Part 11 - IT's Role in Part 11 Compliance - Webinar By EITAGlobal Shared by JamesRichard
Preparing IT resources to install, operate and maintain validated hardware and validated systems requires strong corporate governance, IT management and project management. A well-defined QA program is essential, including elements of Document Management, Records Management, and SOP management.
Once a system is validated, the operational phase of the validated system requires strong IT controls. During the validation process and throughout operation of the validated system, IT controls become essential to maintain compliance with the regulation. IT controls must be well documented with implemented procedures for:
Examples taken from experience in successfully validating systems and electronic signatures for a biotech/pharmaceutical company will be discussed. The company had a sound IT department (email, desktops, file shares and communications worked reliably), but IT governance was immature. Lessons learned along the path to regulatory compliance will also be discussed.
Why Should you Attend:
21 CFR part 11 sets the guidelines for electronic records and electronic signatures, but it does not define how those guidelines are to be implemented. There is extensive preparation required by IT and QA before you can use electronic records and electronic signatures in a manner that will meet regulatory approval and comply with the guidelines.
This webinar provides an overview of documentation requirements and systems that can be used to meet the 21 CFR part 11 regulation guidelines.
Areas Covered in the Session:
Who Will Benefit:Speaker Profile: