Records storing

Compact discs (CDs), which may be found in over 25 million American homes, not to mention backpacks and automobiles, first entered popular culture in the 1980s. But their history goes back to the 1960s, when an inventor named James Russell decided to create an alterna-(5) five to his scratched and warped phonograph records—a system that could record, store, and replay music without ever wearing out. 

As well as GCP site inspections, an examination is imdertaken of the raw or source data and records of Chemistry Manufacturing and Control (CMC), non-clinical and clinical reports that are the basis of the application. This is to ensure that the application dossier accurately reflects the source data. The procedure issued by PMDA details that list of raw data and records must be provided. The applicant is required to bring the data and records to PMDA on the specified days and when the examination finishes they should be retrieved. Therefore, the raw data and records stored at overseas sites are usually categorised as documents not to be submitted and not subject to reliability review by PMDA. Instead, the MHLW may investigate the data from non-Japanese studies at the site of storage since submission of a photocopy of the data is not permitted. 

The instrument uses three recordings stored in memory a spectrum of the sample (composed of the two compounds to be analysed) and a spectrum of each of the pure components in the same spectral domain (reference solutions of known concentrations). 

Description of process validated load containing filling equipment and accessories not to exceed 102 kg Temperature set point for validation 121.0°C Temperature range for validation +0.5°C Cycle validated 35 min Validation records stored in archives A105-11 Revalidation records stored in archives C314-70... 

Archived electronic records stored on maintainable media and in a format that can be read at a later date. 

This clause applies to legacy systems and the electronic records stored by these systems. The no grandfathering clause indicates that Part 11 provisions relating to record creation do not cover electronic records that are created before the effective date of the rule. These records would not need to be retrospectively altered. 

Determination of the accuracy of the system in receiving, recording, storing, and... 

Employee training Are the SOPs clearly written How are they reviewed and approved Are they maintained in the work area or available to employees Are they numbered and versioned Is training documented and assessed How are training records stored and filed Have they been audited Is there evidence of GXP training There should be resumes on file at a minimum. 

Fig. 30. Schematic design of a simple but very useful and efficient data reduction algorithm. Data representing the time trajectory of an individual variable are only kept (= recorded, stored) when the value leaves a permissive window which is centered around the last stored value. If this happens, the new value is appended to the data matrix and the window is re-centered around this value. This creates a two-column matrix for each individual variable with the typical time stamps in the first column and the measured (or calculated) values in the second column. In addition, the window width must be stored since it is typical for an individual variable. This algorithm assures that no storage space is wasted whenever the variable behaves as a parameter (i.e. does not change significantly with time, is almost constant) but also assures that any rapid and/or singular dynamic behavior is fully documented. No important information is then lost...

The appropriate backup media can vary examples include diskettes, cartridge tapes, removable disk cartridges, or remote-networked host computers. The retention responsibilities for backups are the same as for other documentation and records. Stored backups should be checked for accessibility, durability, and accuracy at a frequency appropriate for the storage medium. Beware of wear-out of media when purposely overwritten for reuse. Different media have different life spans. CD-ROMs, for instance, typically have a 10-year lifetime but tapes have a much shorter lifetime. 

Determine appropriate storage medium for archived materials (e.g., ASCII format files, printed records stored to microfiche, etc.). 

Retention periods for electronic records should be the same as equivalent paper records. During the retention period, stored records must be readily available. This applies to records stored on electronic and nonelectronic media. Issues that need to be managed for long-term archiving for electronic records are discussed further in Chapter 13. 

The system risk assessment is seen by the authors as one step of risk assessment when the system produces electronic records. The second part would be an assessment of the risks to the records stored in the system. Very recently, a new guidance document on a risk-based approach to e-records and signatures was published, focusing more on the risks related to records and signatures once they are maintained electronically, and proposes risk mitigation strategies for several types of records based on their risks. 

Criticality of the records stored in the system (record risk assessment)... 

Testing Who develops test plans Are requirement specifications reviews and design inspections done periodically How is functional testing performed Who is testing (outside the development department) Are there test protocols Is there a test traceability matrix to ensure that all user requirements and product functions are tested Are there procedures for recording, storing and auditing test results Who approves test plans/protocols ... 

Going back to the secure electronic data vault system, this novel approach protects (i.e., hides or obscures) the content of the electronic record stored in the secure electronic data vault system even from the system/database administrators by storing the electronic record in an encrypted format. This is achieved by encrypting the electronic record with the record owner s public key and again with the public key of the custodian of electronic records. Therefore the custodian of electronic records needs to decrypt it with its secret key, and the owner of the electronic records needs to decrypt again with its secret key to access the content. 

Tabletting research and development can be carried out in single station punch-and-die presses, which use different drive mechanisms. If used for high precision tabletting or development work, instrumentation is added with which data can be recorded, stored, and processed. For tabletting research, determination of the pressing force over displacement (densification) diagram is of great value [B.97].

There should be provision for making legible copies of records stored on photographic film. 

In many situations, the most likely scenario for failure of freezers is power interruption. In this case, the temperature monitoring and alarm systems need to function in the absence of power. In some settings, generator back-up is appropriate and required. Several types of temperature monitors are available, including those that record continuously on paper discs and recorders that electronically record, store, and alarm in case temperature parameters are exceeded. 

Information system. People, technologies, and machines used to capture or generate, collect, record, store, retrieve, process, display and transfer or communicate information to multiple users at appropriate levels of an organization to accomplish a specified. set of functions. Information systems. The entire infrastructure, organization, personnel, and components that collect, process, store, disseminate, and act on information. 

FIGURE 15.6 Record stored by an ICD of successful delivery of a defibrillation. An atrial EGM, (top tracing), ventricular electrogram (middle tracing), and ICD marker channel are shown. Markers include ventricular sense (VS), atrial sense (AS), ventricular pace (VP), atrial pace (AP), end of ICD capacitor charge (CE), and delivery of shock (CD). (Reproduced with permission of Medtronic, Inc.)... 

The method is best suited for applications which do not require high-performance direct access to records stored on disk, but is highly suitable where files regularly grow in size and where the operator or user does not wish to be bothered with technical details such as defragmentation. 

Carriers would need to retain the electronic records for six months, and have a backup copy of all records stored separately. These records would then have to be presented to auditors upon request (just like logs today). Finally, if the driver requests them, he/she must be provided with all of his/her ELD records that are in the system, including any edits, annotations, or comments that were made on the records. 

---