Overview: Although Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought.
Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of these technical requirements is paramount to avoiding the syndrome of "testing into compliance" later on. Often, the compliance status of a system can be impacted by varying interpretations of the regulation if not properly addressed. This session will provide a focus on understanding the key considerations for the technical requirements of Part 11, to ensure system are compliant from a Part 11 technical perspective and, when coupled with sufficient procedural controls, will result in an overall Part 11 compliant deployment.
Why should you attend: With the announcement in 2010 of a new Part 11 Inspection initiative, life science organizations can expect to see a higher level of scrutiny of the compliance of computerized systems utilized for regulated activities. To avoid any regulatory observations on your automated systems, it is important to ensure that compliance is built into those system from inception. This requires a good understanding of the technical requirements of 21 CFR Part and how to implement them.
Areas Covered in the Session: - Leveraging a Part 11 Interpretation document
- The Importance of Part 11 in Requirements and Specifications documents
- The Role of Risk Assessment in Part 11 Compliance
- Technical Controls for Electronic Records
- The Many Flavors of Audit Trails
- Open vs. Closed Systems
- Technical Controls for Electronic Signatures
- Handwritten vs. Electronic vs. Digital Signatures
- ID/Password Requirements - Records vs. Signatures
- Validation as Proof of Compliance
Who Will Benefit: - IT Managers and Personnel
- QA Managers and Personnel
- Validation Managers and Personnel
- System Vendors
- Developers
- Consultants
