Record Management

Compliance. There is a common approach, taken by companies looking at ELN systems, to view them as risky this is mostly in comparison to what is seen as the gold standard of reliability and low risk, the paper notebook. In fact, there is an alternative approach to thinking about the implementation of an IP and regulatory records management system (which is just what a paper or electronic notebook is) that does take into consideration the risks associated with paper notebooks. 

A well-developed records management program that defines rules by which records and documents are handled from creation to retirement is necessary for a successful electronic data archiving process. In a GLP-compliant system, records are classified by type, such as study-specific raw data, reports, personnel records, etc. Each record type has a defined retention time. 

An important part of any record management system is the ability to take a record, and recognize what it is, what it contains, who produced it and when, whether the person producing it was authorized to do so, whether the contents are still current, its confidentiality status, its copying status and whether it is complete. Much of this can be achieved using simple identifiers on each page of the document. The remainder can be achieved using inventories and lists. Record inventories can be used to list the history of records, which version is current, and which staff are authorized to produce or amend particular types of record, etc. 

Record Management Describe the format, numbering sequence, revision, version control, and storage of the validation documentation. 

International Society for Pharmaceutical Engineering (ISPE) (2002), Good Practice and Compliance for Electronic Records and Signatures, Part 1, Good Electronic Records Management, ISPE and PDA. 

Conduct a review of chemical agent disposal facility operations and records management for the ambient air monitoring for agent, and for exhaust stack and other waste stream emissions of agent and other substances of potential concern (SOPCs) that are characteristic of these facilities. Use Occupational Safety and Health Administration, and Environmental Protection Agency criteria for initial identification and evaluation of SOPCs. 

After being released for use, all computer systems must be periodically reviewed until the system is no longer required for operation. The system documentation, system operation, modifications, deviations, upgrades, and the electronic record management associated with the software application must be reviewed to determine ... 

US Department of Defense, DOD 5015.2-STD—Design Criteria for Electronic Records Management Software Applications, November 1997. 

Trustworthy Reliability, authenticity, integrity, and usability are the characteristics used to describe trustworthy records from a record management perspective (NARA). 

Telephone surveys have the same advantages of face-to-face interviews but tend to be less expensive. Researchers can survey individuals from a large geographic area, and data can be linked to a record management system that can track respondents. Unfortunately, researchers cannot reach respondents who do... 

Batch record management (issuance, review, approval, and release) is the sole responsibility of QA. 

The end of the operational life of a computer system needs to be managed. This chapter discusses the implications of phasing out computer systems as a result of site closures, divestments, and acquisitions. Various system-management and record-management options are discussed. Key steps for all these situations include... 

Comphance issnes affecting records management during divestment can be gronped nnder four topics ... 

An electronic records management framework should be formulated and deployed. Steps within the framework might include ... 

---