Electronic records/signatures definition

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. 

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. 

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 ... 

It is important to preserve or translate as much of the original form and format of the data as possible, and that includes metadata. A database can contain a tremendous amount of metadata, such as audit trail information, electronic signatures, relationships between database tables, definition of field characteristics, etc. It is necessary to consider this metadata as part of the data set failure to do so could inhibit searchability and reporting after migration, make modification of old records problematic, or possibly even result in loss of the integrity of the records. Validation tasks associated with data migration must be geared to demonstrate that neither of these circumstances prevails. 

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