Electronic records definition

When you start working across the Internet, the chromatography data system becomes an open system and the FDA rule requires controls. Using FDA s definition of electronic records, the laboratory chromatography data system generates electronic records. Based upon the definition, laboratories will need to consider more than just the raw data tiles. One must also include the method tiles, mn sequence tiles, and the integration parameters used for the data analysis. The need for a comprehensive audit trail is a critical component of the FDA regulations. The audit trail is an electronic record and is subject to the same controls. 

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. 

Newly sanctioned systems will require compliance with regulations for GMP electronic records and electronic signatures, and definition of the functionality required will need to be included. 

This paper is concerned with the definition and documentation of primary raw data, or in other words, raw data directly associated with a study. Items such as standard operating procedures, methods, personnel qualifications and training records can be considered secondary raw data. Thus, even though these items are also archived, they are not considered explicitly here. But since they are just other examples of paper and/or electronic records, the same archival methods can be used. 

Most definitions of raw data concentrate on paper and/or electronic records. A good, concise definition is found in the FIFRA Good Laboratory Practice document (1) " Raw data means... 

The definitions above are consistent with Part 11. Per Part 11, paragraphs 22, 45, and 72 in the preamble refer to when data on transient memory become electronic records. In summary, the primary attribute to take into consideration for the above definitions is record retrievability. It is essential to take this into account when deciding the applicability of Part 11. 

For this definition, the primary attribute to take into consideration is whether the data is accessible once it is put into storage, not the retrievability of the record. This definition would consider data in transient memory to be an electronic record. 

The purpose of the following checklist is to help to determine if a computer system complies with the FDA Rule 21 CFR 21 Part 11 for electronic records and electronic signatures. This audit questionnaire apphes to systems that meet the definition of a closed system as defined in Section 11.3 (b)(4) of the rule and which do not utilize biometrics identification methods. 

Data Definition (inch X X X X documentation To cover electronic records and any data configured/bespoke... 

Practical definition of what constitutes an electronic record... 

Open Source software must be fully evaluated by the user organization to assess relevant electronic record/signatnre fnnctionality since there is no snpplier acconntable for fnnctionahty definition, product development, or maintenance. Cantion shonld be exercised since it is very difficult to truly demonstrate the trustworthiness of such software in the absence of life-cycle development and support documentation. 

Electronic records can be identified by searching regulatory requirements for the key words record and document. This appendix is based on the U.S. Code of Federal Regulations and EU Directives, and is not intended to be exhaustive. More definitive listings are expected to be published by industry groups such as ISPE/GAMR... 

From time to time it may be necessary to remove data or other electronic records from an on-line computer system to another durable secure location for long term off-line storage. This removal also includes the removal of the metadata associated with the record, for example, the properties of a Microsoft Word document or a series of data definition and table relationships. 

The Internet is a classic example of an open system in the definition of 21 CFR Part 11 Open system means an enviromnent in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. As illustrated in Figure 39.2. ISPs have access to data, which means the persons who are responsible for the content cannot control access to any data transferred through the Internet. 

In September 2003, a new guidance document came out, which was in line with the overall risk-based approach of the FDA. It narrowed the scope of Part 11 to those records explicitly required by predicate rules. Furthermore the guidance stated that until Part 11 is reworked, enforcement discretion would be applied to certain aspects of Part 11 concerning validation, audit trail, and electronic copies and archiving, as long as predicate rule requirements are met. It also indicated that a risk-based approach would be suitable to evaluate which measures are necessary for complying with Part 11. As will be discussed further below (see section Definition of Electronic Records ), this applies mainly to audit trail and electronic copies, and archiving. 

Therefore, it is the first task of the business process owner to define which records under his area of responsibility are electronic records and which not. The best approach is to have a defined and documented business process. Then the records growing out of this process can be determined. In the next step, systems supporting the process are identified, and records in the system assessed. The business process definition will also be needed as a basis for the record risk assessment and validation activities of a system. An example on how this can be documented is given in Fig. 2. 

Based on the information gathered during the definition process for electronic records, the risk for the records can be assessed. Such a risk assessment is... 

There are two aspects to consider. The first covers the question of the definition of an electronic record. If the data is collected by the system, or is transferred to it via an interface, and the following evaluations are done without human interference, then it may be wise to revise the definition of the electronic record. The result of the evaluation, which is used for GxP-related decisions should be considered to be the first electronic record created during the process. This evaluation result may not have the same demands as to processability (e.g., the individual data point collected by a process control system vs. the curve generated to evaluate the batch). 

Nevertheless, in many cases, there will be no possibility to use a suitable definition of electronic records to avoid the copying problem. Usually then the only way will be to provide the data itself and the methods used for the evaluation in a generally readable format, e.g., ASCII. Even though the reprocessability of the data is then not given as such, this approach at least guarantees that copies are available within the described limits. 

If raw data are transcribed to a computer database, neither the electronically stored data nor the paper printout can substitute for the original. Information entered into the computer by direct data capture offers two options, however. The laboratory may elect to treat the electronically recorded information or a hard copy printout of the information as raw data. If the hard copy is retained, the magnetic media can be discarded or reused. If a laboratory elects to treat the magnetic media as raw data, it must retain an ability to display the data in readable form for the entire period during which that information is required to be retained. (See 58.195 for a definition of required retention periods.) If a change in computer systems would entail the loss of the... 

The general definition of a risk in this context is "a measure of the probability and severity of undesired effects", and more specifically for LIMS software, the critical functions and how they may affect LIMS data. The criticality of the data associated with electronic records and signatures is also a key subject for the regulators at present this subject is discussed later in this chapter. The intention of the risk assessment is to consider the following areas ... 

The definitive resonance Raman spectra obtained by Clark and Franks for [(C4H,)4N] 2Re2Cl8 and [(C4H,)4N]2Re2Br8 were particularly informative (49). The observation of resonance enhancement in the Raman spectrum recorded with excitation frequencies in the range of the lowest electronic absorption near 14,000 cm 1 not only provided useful vibrational data, but also confirmed that this electronic absorption was electric dipole allowed in accord with the S- 5 assignment. Normal Raman spectra were obtained with excitation energies differing substantially from the absorption maximum near... 

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