- Recording raw data in a bound journal is still an acceptable way to keep data. I found it interesting to learn that "a computer printout derived from data transferred to computer media from lab data sheets is NOT considered raw data" by the FDA (www.fda.gov, Guidance For Industry). Raw data refers to unanalyzed, unprocessed data. While most QA labs store and report final results in formal lab reports or certificates of analysis (COAs), it is a good lab practice to keep raw data. Many QA labs utilize various computer programs for electronic data storage so that the data can be easily transferred to other software programs. Electronic data journals are also available now. While electronic storage is very convenient and minimizes the use of paper files, you must consider how this data will be protected and how to back it up. After experiencing a minor scare recently, I can't recommend going totally paperless. Record keeping is like oxygen ... you don't notice it until it's missing! Consult a lawyer to determine if electronic data storage will work for your business.
- Maintaining data sheets in a 3-ring binder is also acceptable. Binders are great for storing records that are constantly evolving, such as pest control and sanitation records.
- Consistency is important. Determine which parameters should be recorded for each analysis and make sure lab employees have been trained so that the raw data is recorded the same way each time the analysis is performed by each analyst.
- It is a good practice for the analyst to sign and date the data entry and to record the method or lab protocol number. In some circumstances, it may be necessary to record the time of the entry.
For more information about electronic data usage and considerations, refer to:
1) 21 CFR Part 11
http://www.accessdata.fda.gov/scripts/cdcs/cfcfr/CFRSearch.cfm?CFRPart=11rh/cfdo
When you get to this website, scroll down inside the box to number "11) Electronic Records; electronic signatures".
For more information about laboratory record keeping, refer to:
2) Good Record Keeping: Procedures For Academic Laboratory Settings
http://www.research.ufl.edu/otl/goodrecords.html
For some information about what types of records to save from a legal point of view, refer to:
3) Intellectual Property Audit Checklist
http://www.singletonlawfirm.com
For some instructions on how to prepare laboratory standard operating procedures, refer to:
4) http://www.fao.org/docrep/w7295e/w7295e04.htm
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