Definition of Raw Data

Within EU Chapter 4 – Documentation there is a clear definition of Raw Data and the requirements to retain the raw data.

Records: Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution. Records include the raw data which is used to generate other records. For electronic records regulated users should define which data are to be used as raw data. At least, all data on which quality decisions are based should be defined as raw data

Electronic Raw Data

This provides clear definition of raw data and the regulatory requirements.

Where paper based records are maintained the regulated company should determine whether all the raw data is presented within the paper record or whether the record is a summary of the data. If it is a summary of the decision (for example within Laboratory Analytical test systems where the samples are taken, interpreted and a final result included) then the electronic raw data must be maintained to assure the integrity. Where the paper record is the complete record then the electronic data may be removed (see Deleting Electronic Data).

Raw Data will exist in many computerised systems and should be identified during the initial impact or validation determination statement. Examples of raw data maintained by computerised systems include

• Quality critical process data from instruments stored within data historian
• Alarm logs from automation systems
• Event logs and audit trails
• Laboratory instrument data
• Environmental monitoring data

Following from the final guidance from the FDA for 21 CFR Part 11, Electronic Records Electronic Signatures the regulated company must identify all raw data associated with making GMP decisions and determine what format (paper / electronic) that the data will be maintained. If the raw data is to be maintained in electronic format then the integrity of the record must be assured.