Quality electronic records

Similarly, the EPA is concerned with the quality and integrity of electronic records. EPA s CROMERRR proposal establishes requirements that must be met by the... 

Computerized System Requirements and Electronic Records Increasingly, computerized systems and electronic records are part of a laboratory s operations. However, records may be held in both paper and electronic format and the quality assurance required depends to some extent on the format of the definitive document. Because of space requirements involved with paper records and ease of retrieval of electronic records, the latter are gaining in popularity. The same requirements that we have for paper records, e.g. change control, readability and archiving, will still apply to electronic records. For this to be achieved, new procedures may have to be developed. 

All of the above may appear to involve a great deal of effort but the extent of the effort should be based on the level of risk involved. The starting point should therefore be a risk-based assessment, categorizing the systems as high, medium or low risk based on their impact on the quality of the final result. Electronic records that are generated by systems that are critical to the study should be examined in detail for the whole of their life cycle. The following process is a way to approach the risk-based investigation ... 

It is essential that all data generated and any other records or samples (if possible) are retained so that they are available for inspection at a later date. This means that there must be a secure and properly controlled archive, with an archivist to maintain it. The archive will contain a copy of the Study Plan, quality assurance reports, records of staff including their curriculum vitae (CV) and training records. Access to the archive has to be strictly controlled, and any additions to or withdrawals from the archive must be logged (see also electronic records in Section 9.2.1.8). Such removal or additions can only be undertaken by stated personnel. 

Maintenance records Application software documentation Data reproduction accuracy Documented verification of process steps Operator identification Data record review by quality control Electronic record/signature type, use, control, and audit trail... 

In considering electronic records and electronic signatures (ERES) the pharmaceutical manufacturer must address the system quality-related critical data collection and processing functions that come under ERES regulations (see Secs. IV and V). 

It is very important to ensure that having a signed paper-based record (e.g., a report) associated with one or more electronic records, the electronic file(s) associated with these records must not be deleted. The Part 11 regulation is very specific regarding this issue. Electronic files in hybrid systems must be maintained electronically. The interpretation of this requirement in the medical devices CGMP regulations (21 CFR 820) is different. Part 820 requires that the results of acceptance activities are recorded, but are not necessarily raw data, and these results must have audit trails. This interpretation is contained in the medical device quality system preamble (pp. 52631 and 52646). 

Part 11 regarding validation of computer software and hardware. Any software used to operate process equipment, generate electronic records, track and transmit laboratory data, automate quality systems, operate critical utilities or software that is itself a medical device must be validated to ensure accuracy, reliability, consistency, and the ability to discern invalid or altered records. Where off-the-shelf software is used for any of the above cGMP activities, it must also be validated for its intended use. For additional information on compliance issues related to computer hardware and software validation refer to Chap. 7 of this book. 

Examples of quality assurance protocols that are considered standard practice in any data collection scheme include the use of both internal control samples (e.g. use of field blanks and spikes6) and external quality assurance samples (e.g. duplicate samples of known concentrations sent to different laboratories) to determine the extent of intra- and interlaboratory variation. Ensuring that the data have not been compromised or corrupted may also require setting up accessible data archives of original paper or electronic records so that the accuracy of summaries of the data published in documents and articles can be verified. 

The need for authorization, review, and approval of each electronic record in response to regulatory or internal quality requirements needs to be determined. Where electronic records are signed electronically, the technical controls required by regulations such as U.S. FDA 21 CFR Part 11 need to be implemented within the system or a secure hybrid (signed printout of the electronic record) solution applied. 

Typically, records associated with IT operations will not be direetly attributable to produet quality or research and development data integrity. However, IT reeords are subjeet to regulatory inspection and therefore subject to the electronic records and electronic signature eontrols in U.S. FDA regulatory citations. Typical electronic records may include ... 

Electronic records requiring particular regulatory control should be identified based on critical process control points and associated critical parameters that directly impact product quality or product safety. A defined process should be used to conduct this analysis, and it should be one that builds on or is complementary to any assessment conducted as part of product registration. Consistency is key. There may be additional records identified by predicate rules but care must be taken not to extend beyond these records. A risk assessment should be conducted to determine appropriate electroific record management controls such as audit trail and archiving. Electronic records will need to be archived for retention periods specified in predicate rules. Other data related to process performance rather than product quality or product safety requires only basic data maintenance and may be retained for much shorter periods before being purged. 

The parameter settings are stored in the system and are considered to be electronic records, but they can be considered to have low impact on the product quality. There is a monitoring system in place that controls whether the required environmental conditions are met, and for the evaluation of the product quality during the batch record review, only the results of the monitoring systems are included... 

Good laboratory—what it is, how to apply it, p. 125 e How to vahdate a method selectivity, hnearity, accuracy, precision, sensitivity, range, LOD, LOQ, ruggedness, p. 126 Quality assurance control charts, documenting, proficiency testing, p. 133 Electronic records, p. 135... 

Validation approach, quality assiuance and auditing Electronic records and signatures Specification and design Reporting... 

The supplier must not only be able to show that there is a QMS but also that it is actively used. SAP manages quality management documents and quality item lists electronically and thus ensures that employees have constant access to the most up-to-date information. Because it is managed electronically, it is possible to construct automatic workflows to ensure that the process steps prescribed are followed. It is important to note that suppliers do not have to conform with U.S. 21 CFR 11 governing the use of electronic records and signatures. Customers should nevertheless expect suppliers to ensure that electronic records are secure and that their integrity cannot be compromised by data corruption or unauthorized manipulation. 

The regulation, despite its lengthy gestation period, does not fit seamlessly into the GxP context with which we are familiar. As indicated earlier, all of the existing rules of GxP continue to apply, including, for instance, the need to validate the systems (both quality and computer) where electronic signatures are used and electronic records are generated. 

Specific information about each endoscope (i.e., manufacturer, diameter, length, tip angle, depart-ment/unit, control number, and operator), the reason for the test (i.e., quality control, pre/post repair, etc.), and any problems associated with the scope are also documented through the electronic record. In addition, all the quantitative measurements from each test are automatically appended to the electronic record for life-cycle performance analysis. 

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