Record keeping systems

In a GLP-compliant electronic record keeping system, original raw electronic data will not be altered, but these data can be presented and interpreted for reporting. Any changes to the raw data are documented and maintained as audit trails. The audit trail becomes a part of the raw data for the study and is archived as such. 

This inspection disclosed deficient controls in the laboratory electronic record keeping system which is used for maintaining chromatographs and audit trails. [FDA Warning Letter, 2000]... 

The lack of validation or incomplete validation was the next most common observation. The need for prospective validation of electronic record/signature capability during computer system implementation is stressed in two of the six Warning Letters, making an observation on validation. The compnter systems concerned were Computer Aided Drawing, Process Control Systems, Record Keeping Systems, and EDMS. 

Security as a topic is referred to the same number of times as backup and archive. Security issues raised stress the need to limit access to computer systems to protect records, and in one instance deficient password controls are mentioned. Computer systems referred to include CDS, CAD, Record Keeping Systems, and Spreadsheets. 

What is the overall security of the electronic record-keeping system ... 

Gallup, D., Beauchemin, K., Gillis, M., Altopiedi, D., and Manor, J. (2003), Selecting a Training Documentation/Record-Keeping System, PDA Journal of Pharmaceutical Science and Technology, 57(1), January/February. 

Meticulous record-keeping systems are essential to cope with the immense amount of data generated in an oncogenicity study. Palpations to... 

There should be a written procedure for implementing a manufacturer s product recall, and records of any recalled products received into the warehouse should be kept It is useful to have a record keeping system by batch which would assist with effective recall from the retailer. A person should be designated as responsible for execution and co-ordination of recalls. 

Maintain a reporting and record keeping system to monitor job-related injuries and illnesses... 

One file for all Schedule II-V controlled substances. If this method is used, a prescription for a Schedule II-V controlled substance must be made readily retrievable by use of a red C stamp not less than 1 in. high. If a pharmacy has an electronic record keeping system for prescriptions which permits identification by prescription number and retrieval of original documents by the prescriber s name, patient s name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red C is waived. 

Design of record keeping systems that allow for collection, storage, interpretation, and dissemination... 

Do you have an adequate record-keeping system which tracks maintenance, repairs, and inspections ... 

The record keeping system should be designed to retain aU relevant information about the collection of individual samples, measurements of samples, cahbration procedures and uncertainties, as well as summaries of the results that are reported routinely. Similar information should be kept for samples collected for the purpose of determining the radiation background. 

Data from individual monitoring should be recorded and documented for assessing the individual doses received in a particular time period and for confirming that the doses comply with the dose hmitations attached to the discharge authorization. The record keeping system should be designed to retain as much basic information as necessary for the purposes of the assessment of individual doses. 

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