Computer electronic signature

Traditionally, documentation has been maintained on hardcopy paper systems. However, soft copy computer records are permitted provided it can be assured that the records can be maintained without corruption. More sophisticated systems that are used to create electronic records and electronic signature must be capable of... 

Computer applications allow for defining and managing several important nonclinical data types that are managed by the system itself. Such data are referred to as metadata or control data. These are information such as domain-specific descriptions, application conditions, parameters, and methods in a repository. Control data fields can be part of the data collection forms or in system-defined tables. Some of these control fields include electronic signatures, form status, transmission date, transmission number, field completed, and memo fields (large text format). The database contains tables for reference ranges, visit schedule, form schedule, labels, and drug codes. 

Some fairly common mistakes made in managing electronic SOPs, protocols, and changes to them are listed below. If these can be avoided, the resulting computer system should meet the requirements of the US, Organization for Economic Cooperation and Development (OECD), and Ministry of Health, Labor, and Welfare (MHLW) GLP standards as well as the FDA s Rule on Electronic Record Keeping Electronic Signatures. ... 

Automated dissolution equipment in most cases must be compliant with the FDA electronic records and electronic signatures regulation (21 CFR Part 11). The requirements of the regulation include use of validated systems, secure storage of records, computer generated audit trails, system and data security via limited access privileges, and the use of electronic signatures. 

Electronic Records and Electronic Signatures Considerations ERES compliance testing for computerized (personal-computer-controlled) instruments is required to demonstrate the functional requirements in the following three key areas [12-14] ... 

Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual s handwritten signature. 

It is opportune at this point to document the GMP electronic raw data that need to be collected by or through the computer system. This will be used to support the validation rationale and influence the extent of qualification testing. It will also identify candidate data for electronic records and electronic signature compliance and help distinguish between electronic raw data and transient electronic data. 

As a result of the fundamental principles above, all computer systems performing regulated operations must protect their electronic records by means of access controls, audit trail controls, and Part 11-associated operational checks. For those computer systems that implement electronic signatures, the security and control of electronic signatures must also provided. 

The use of audit trails is not restricted to the modifications of the records. Audit trails may also be used to record operator entries and actions during the operation of the computer system, which can be recorded without the application of electronic signatures. 

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. 

Computer validation costs can be considerably higher than those metrics quoted above if bespoke functionality has to be incorporated for electronic record and electronic signature compliance. 

Computer systems that do not behave in the necessary manner (e.g., electronic record and electronic signature requirements)... 

The purpose of an electronic signature in a computer application is to enable an individual to authorize an electronic record (e.g., author, review, approve, comment, etc.). Appendix 15B helps identify examples. 

Open systems refer to computer setups in an environment where a specific person who is responsible for the stored data does not control system access. A good example of an open system is the Internet. Specialist controls are required such as encryption and digital signature standards like Public Key Infrastracture (PKI) to provide necessary assurance in electronic records and electronic signatures. 

Training records should be maintained that demonstrate that individuals, as appropriate, have sufficient education, training, and experience to develop, use, and maintain computer systems that support electronic records and electronic signatures (see also Chapter 4). 

Selby, D. (2000), Practical Implications of Electronic Signatures and Records, in Validating Corporate Computer Systems Good IT Practice for Pharmaceutical Manufacturers (Ed. G. Wingate), Interpharm Press, Buffalo Grove, IL. 

Electronic Records and Electronic Signatures Number of Paragraphs in Warning Letter Dealing with Different Computer Issues... 

AU this makes good business sense and should eliminate the need for corrective work because of misunderstood validation requirements. Similar harmonization would appear to be occurring on the topics of electronic records and electronic signatures. Mutual Recognition Agreements (MRAs) between various national regulatory authorities such as the FDA, MHRA, TGA, and MHLW and the work of the International Conference for Harmonization (ICH) offer an opportunity to formally consolidate harmonized computer validation requirements. 

Common problems both on the operational and support aspects of the computer system should be part of any validation plan, e.g., backup works and incorrect data inputs can be corrected in a compliant way with corresponding audit trail entries. The predictability of the system under these tests must generate confidence in the CDS operations (trustworthiness and reliability of electronic records and electronic signatures) and the IT support. 

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