Make sure you are using a client that supports Cfr 21 part 211 pdf. Thank you for visiting www. Red Apple book’ which described how to handle IT systems in the US pharmaceutical regulations.
While requirements for validation of computer systems were first introduced in these books, the FDA did not do much to publish formal requirements. Several FDA employees wrote publications about the FDA’s views and the FDA started to enforce the requirements that it had not formally stated. If the GxP dictates control over a process, then the IT system controlling that process also needs to be under control. Inspectors issue discrepancy reports based on the text in the relevant predicate rule, and maybe, additionally, state that the GxP or IT system isn’t in compliance with 21 CFR Part 11. Even if the document does cover electronic records and electronic signatures, there are few suggestions for how to get in compliance.
People who have worked with IT systems in the pharmaceutical industry in the roles of key personnel, validation experts, Quality Assurance, and so on know a lot about 21 CFR Part 11 already. The FDA also added to the confusion by first issuing a number of draft guidance documents making the regulations more and more strict, and then suddenly withdrawing them all in 2003, and replacing them with one new guidance document for a risk-based approach to 21 CFR Part 11. This document leaves it up to the discretion of each organization to assess the importance of its computer systems, and to handle the high-risk systems carefully and the lower-risk systems a bit more leniently. The risk assessment itself must be documented. If risk assessment shows that a system does not represent a high risk for the data, less validation and less stringent requirements apply. There may be discussion about whether adding the risk assessment reduces the total amount of work, but at least each company has the possibility of reducing some of the validation activities and some of the technical requirements stated in Part 11.
Let us come closer to Part 11. Validation requirements, only stated in Section 11. As you could see below I would like to describe what each requirement of 21 CFR Part 11 means and how to comply with each requirement. Electronic records in closed systems, as described in the 21 CFR Part 11, have several requirements in place to ensure the authenticity and integrity of data. Please refer to the document for the full text of the requirements. Validation includes all stages of the system, from the first planning of the system requirements to retirement of the system.
In addition to validating the system functions, based on the User Requirements Specification, all technical Part 11 requirements must also be validated. The nicest looking ones are made using a report generator, where a good layout makes the report easier to read. The trained user can quickly make reports using a good reporting tool to make ad hoc reports in a human readable format. However, until they are qualified these must be used with care, as they may not show the correct data. Electronic records may only be readable while the system is live and in working order, but the data will probably still be needed when the system is no longer available. There are several options available: It is clear that the investigators want the ability to make electronic copies.