Electronic document and records

Direct access to electronic documentation and records should not be offered to the inspector/investigator. If direct access is requested by the inspector/investigator, the legal department should be informed. The inspector/investigator is not an employee of the company and would have to be properly approved, involving authorization, suitable training, and competency to have access. Such access could also violate the security (e.g., closed system status) of the company s computer systems. Similarly, inspectors/investigators should not be permitted to connect their own computer systems to pharmaceutical or healthcare companies systems. 

Where copies of electronic documentation and records are provided to an inspector/investigator to take away, they should be provided on read-only media (preferably write-once, read-only). The same issuance process should be followed as for paper documentation (e.g., signed handover of copy to inspector/investigator, and an exact duplicate copy made on the same media as provided to the inspector/investigator for retention by site). Ad hoc electronic reports from computer systems specifically requested during inspections do not have to be validated. ... 

As a result, electronic document and records management systems (ERMS) are becoming more and more essential in this environment in order to handle the volume of data and related documents as well as to verify the quality and the integrity of the data for FDA auditors. ERMS have become critical for research and development in the biotech and pharmaceutical industry to the extent that the FDA created... 

In connection with the actual, experimental conduct of the study, it is the responsibility of the Study Director to ensure that all raw data generated are fully documented and recorded in compliance with the GLP Principles. For data recorded manually this entails ensuring that the data have been recorded promptly and accurately and in compliance with these Principles of Good Laboratory Practice if data are recorded electronically through the utilisation of a computerised system, the Study Director should ensure that (the) computerised systems used in the study have been validated , and are fit for use in the study. 

Copies of records or documents, is a regulation that allows you some flexibility in maintaining required records and documents. Simply put, it is permissible to maintain photocopies, microfilm, and even electronic copies and records in lieu of original hard-copy records and documents. 

Electronic chart systems are the base for further, more advanced automation of navigational process performance, plus its fiill documentation and recording. 

FDA. Draft Guidance for Industry on Part 11, Electronic Records Electronic Signatures—Scope and Application Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide, Fed Regr 68 (37), 8775-6 (25 Eebruary 1997). 

The use of electronic systems and automated electronic capture systems is ever increasing. These systems provide greater efficiency in the generation and management of records and documents than paper and manual processes. Thus, paper and manual processes are being replaced by the use of these systems. In order to prove... 

GLP compliance for electronic records does not differ from GLP compliance for paper records. The increased access and distribution of records and documents enabled by electronic systems provide compliance challenges. There are many new questions to answer for example, what is the difference between electronic approvals and electronic signatures The solutions to these challenges lie in ensuring that system validation and management processes are in place, such as SOPs or procedures... 

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. 

In 1990, the FDA published the electronic records and signatures rule as an initiative for the pharmaceutical industry. This allowed the use of electronic signatures in lieu of handwritten ones. This initiative opened the door to fully electronic documents. The rule became effective in August 1997 and addresses both electronic records and electronic signatures. 

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. 

Documentation comprises procedures, instructions, test methods,batch records, and so on that are documented and controlled. Documentation is prepared, reviewed, and approved by qualified personnel. Approved copies of documents are distributed to relevant departments and superseded copies are retrieved and archived. The retention period for each type of document is specified. Documents are issued with document and version numbers for ease of identification and reference. Master copies of documents are filed at secured locations with authorized access. Master copies stored in electronic media require validation in accordance with FDA regulation 21 CFR Part 11 (see Section 9.6.3) to assess the security of access and data integrity. Operators are trained and retrained to only apply the latest approved documents. 

Records are retained for an appropriate length of time (generally 10 years or two generations over treatment duration) in machine-readable form. This is perhaps the most technologically controversial provision. While it is theoretically possible to retain machine-readable records (ASCII, e.g.—the alphanumeric code—is several decades old), the hkelihood that a formatted electronic document will be physically readable several years later is remote. Consider, for example, the 514-in. floppy disks of 10 years ago and the fact that new sizes of CDs are currently being introduced. 

Reports may be considered to be reviews. For electronic documents that provide an interpretation of data drawn from electronic records that are already subject to control, there is no clear need to reimpose these controls until the document is used for some official purpose. In a case of submissions, once a submission has been assembled and approved ready for submission to a regulatory agency it would then become an electronic record subject to audit trails. 

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