Electronic records elements

Overall Approach to Part 11 According to Guidance for Industry Part 11, Electronic Records Electronic Signatures—Scope and Application The approach is based on three main elements ... 

These two latter elements are not identical on all systems. Electronic signatures are tested when the technology is implemented. An element out of the scope of this model is the retention of electronic records, but the model should be used to verity and validate the implementation of the system(s) that will hold these records. For applications using electronic signatures, the current validation practices requires inspections and/or testing for many of the following technical controls ... 

The second fundamental element in Part 11 is the high level of security required to protect regulated electronic records. The requirements for application and network component security can be found in Table 15-1. The controls that are implemented resulting from the security related requirements are intended to build a trusted digital environment. The attributes relevant to a trusted digital environment are ... 

Metadata Data describing stored data that is, data describing the structure, data elements, interrelationships, and other characteristics of electronic records (DOD 5015.2-STD). 

For hybrid systems, the electronic record requirements in Part 11 (Sub-Part B) are applicable. The electronic records are maintained and retained in electronic form for the period established by the predicate regulation that require these records. The elements of Part 11 applicable to hybrid systems are ... 

In addition to security elements referenced in the previous case, additional security functions are needed to cover electronic records. External safeguards must be in place to ensure that access to the computer system and associated data is restricted to authorized personnel. 

As part of the action of signing an electronic record, the purpose of the signature must be identified and be an element of each signed record. In the drag CGMP arena, there are relatively few purposes for a signature and these include authored by, reviewed by, and approved by The execution of an action such as a production step does not require an electronic signature, and can be documented via the audit trail. 

The arrival of ions at the opening of one of the array elements causes a shower of electrons to pass to the end of the collector, where they are recorded as a current flow, which is usually amplified. 

In Total Reflection X-Ray Fluorescence Analysis (TXRF), the sutface of a solid specimen is exposed to an X-ray beam in grazing geometry. The angle of incidence is kept below the critical angle for total reflection, which is determined by the electron density in the specimen surface layer, and is on the order of mrad. With total reflection, only a few nm of the surface layer are penetrated by the X rays, and the surface is excited to emit characteristic X-ray fluorescence radiation. The energy spectrum recorded by the detector contains quantitative information about the elemental composition and, especially, the trace impurity content of the surface, e.g., semiconductor wafers. TXRF requires a specular surface of the specimen with regard to the primary X-ray light. 

The chemical and electronic properties of elements at the interfaces between very thin films and bulk substrates are important in several technological areas, particularly microelectronics, sensors, catalysis, metal protection, and solar cells. To study conditions at an interface, depth profiling by ion bombardment is inadvisable, because both composition and chemical state can be altered by interaction with energetic positive ions. The normal procedure is, therefore, to start with a clean or other well-characterized substrate and deposit the thin film on to it slowly at a chosen temperature while XPS is used to monitor the composition and chemical state by recording selected characteristic spectra. The procedure continues until no further spectral changes occur, as a function of film thickness, of time elapsed since deposition, or of changes in substrate temperature. 

---