Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is there anything in the regs that we can use to go to vendors with asking for their validation documents? Most vendors I’ve spoken to are protective of their systems and validation documents. 1.62K viewsClinical Research 0 Votes 1 Ans Is Part 11 applicable if site uses a secure drive (limited access) to archive a portion of the regulatory binder? 1.68K viewsClinical Research 0 Votes 1 Ans What documentation can a site reasonably expect a vendor to release to them, since most vendors consider their documentation proprietary. 1.69K viewsClinical Research 0 Votes 1 Ans If a site used RedCAP to collect data for investigator initiated studies that will later be sent to the FDA for approval, must the site have a System Validation process for their RedCAP? 1.30K viewsClinical Research 0 Votes 1 Ans If the vendor provides validation documents as evidence and upon review internally, it meets our requirements, do we (as the investigator site) still need a validation document? 1.29K viewsClinical Research 0 Votes 1 Ans If you validate in a test/validation system, should you re-validate once you’re in the live/production system? Can we skip the test/validation site and validate directly in production? 1.61K viewsClinical Research 0 Votes 1 Ans When do I need to be 21 CFR Part 11 Complaint? 1.65K viewsClinical Research 0 Votes 1 Ans What is the New 21 CFR Part 11 guidance emphasizes data integrity? 1.49K viewsClinical Research 0 Votes 1 Ans Why do packagers, labelers and holding companies have to have Master Batch Records and Batch Production Records from the manufacturer? 1.46K viewsClinical Research 0 Votes 1 Ans How do I deal with a software vendor who issues automated patches (such as virus scan engine updates, bug fixes, hotfixes, etc.) and won’t agree to notify us ahead of time? 1.64K viewsClinical Research 0 Votes 1 Ans What is the Scope of the FDA Guidance? 1.79K viewsClinical Research 0 Votes 1 Ans What are the Electronic Systems Owned or Managed by Sponsors and Other Regulated Entities? 1.70K viewsClinical Research 0 Votes 1 Ans What are the Outsourced Electronic Services? 1.50K viewsClinical Research 0 Votes 1 Ans What are the Key Concepts About 21 CFR Part 11, Electronic Records and Signatures? 1.35K viewsClinical Research 0 Votes 1 Ans Does Part 11 apply if we’re keeping both electronic AND paper copies (i.e. wet ink copies are scanned and saved to our shared drive)? 1.36K viewsClinical Research 0 Votes 1 Ans Do network shared drives really need to be validated? 1.50K viewsClinical Research 0 Votes 1 Ans How do you decide what is “critical” and should be tested? 1.63K viewsClinical Research 0 Votes 1 Ans How does this apply to resident/fellow research being tracked on in-house excel files? 1.58K viewsClinical Research 0 Votes 1 Ans Does this presentation is refer to general computer systems or the electronic health records (EHR)? My understanding is that the FDA does not oversee the EHR? 1.47K viewsClinical Research 0 Votes 1 Ans I often hear the terms Validation and Qualification when referring to computerized systems. What’s the difference between those two terms, if any? 1.68K viewsClinical Research « Previous 1 2 3 4 5 6 … 18 19 Next » Question and answer is powered by anspress.net
