Standard operating procedures archiving

Yet under the original requirements of 21 CFR Part 11 both companies would have had to conduct extensive test on the software to write and implement eight to ten standard operating procedures to document the requirements, development, and change history of the code and to record and archive all records. In this case, as in so many, such an investment in time and dollars would have been justihed for the pacemakers but wasted in the case of the tongue depressors. 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

Applications to and harvest of major crops such as coffee, bananas, and pineapples frequently involve procedures and equipment for which standard operating procedures have not been written. These must be identified in the planning stage, so that the Study Director or Principal Investigator can write these procedures with sufficient time to allow for review and approval. If a procedure is specific to the trial at hand, the process may be described in an addition or amendment to the protocol, but this still requires QA and management approval. In some cases, SOPs specific to a local crop are maintained at a regional site. SOPs must also be available at the site at which the raw data are archived. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

This paper is concerned with the definition and documentation of primary raw data, or in other words, raw data directly associated with a study. Items such as standard operating procedures, methods, personnel qualifications and training records can be considered secondary raw data. Thus, even though these items are also archived, they are not considered explicitly here. But since they are just other examples of paper and/or electronic records, the same archival methods can be used. 

There were no written Standard Operating Procedures for archival. [FDA 2001]... 

There were no written user standard operating procedures. .. [for] system validation, hardware and software change control, revalidation, user operations, security guidelines, software revision control, virus detection, disaster recovery, and backup and audit trail archival. [FDA 483, 1999]... 

The documentation supplied with the CDS application or system (both hardware and software), user notes, and user standard operating procedures will not be discussed here as it is too specific and also depends npon the management approach in an individual laboratory. However, the importance of this system-specific docnmentation for validation should not be underestimated. Keeping this docnmentation cnrrent shonld be considered a vital part of ensuring the operational validation of any compnterized system. The nsers should know where to find the current copies of documentation to enable them to do their job. The old versions of user SOPs, system, and user documentation shonld be archived. 

The OECD covers a series of activities and personnel. Responsibilities, training, quality assurance (QA), standard operating procedures (SOPs), study plans and study reports, data production and recording, equipment maintenance and calibration, computers and validation, test systems and test substances, and archiving are the primary areas covered by the GLPs. 

Standard operating procedures (SOPs) are detailed descriptions of analytical methods (or of other laboratory tasks such as weighing or document archiving). 

Standard Operating Procedures to be written, approved, distributed, used, maintained, revised, and finally archived in chronological order, and GLP wants also to ensure that all activity areas are properly covered by SOPs. 

To comply with the new legislation the sponsor needs to develop a set of standard operation procedures (SOPs) to cover all areas of trial activities. A quality system should be in place to ensure record-keeping and verification of data entry or extraction of data from the case report form (CRF), capture adverse events (AEs), serious adverse events (SAEs) and unexpected serious adverse reactions (SUSARs) and report in an expedited manner data transfer from source data to database and archiving of the source data for audit purpose. GCP and trial specific training should be carried out and recorded in a timely manner. 

The validation of data also is an important step in the process. Validation begins at the station with standard operating procedures for self-consistency of operations and maintenance and with systematic calibration of instruments. Air quality instruments are not particularly reliable so that frequent, careful calibration is required for useful data acquisition. Validation of data is continued after transmission before archiving. To maximize reliability, validation involves a dedicated scientist and engineer whose experience permits identification of possible errors or inconsistencies in reported observations. Finally, the validation process is cross-checked with station performance audits and laboratory intercomparisons to identify discrepancies in analytical procedures. This chain of activity generally makes air quality a rather expensive commodity, a fact that is not appreciated by many users. 

All procedures in the laboratory including sample preparation, analysis, and reporting must have a written standard operating procedure. Any deviations from this procedure for whatever reason must be documented and approved. Should it be necessary to revise the SOP the reason should also be documented and the original procedure archived. Employees should know via written documentation how much they are empowered to vary all procedures used. 

All of this is possible only if the measurement follows a properly validated standard procedure. In order to assure continuity and accountability, this must be properly documented. In addition to the more immediate preoccupations of method and equipment, there must be an overall administrative system in operation which ensures that equipment is checked at appropriate intervals, that information is archived properly, and that unexpected results are assessed properly. The system must allow for necessary change. If, at some point in time, it becomes necessary to alter the procedure, the changes must be fully validated and documented. Situations will inevitably arise for which the standard procedure is not appropriate. In snch cases, the system must allow the actual procedure followed to be recorded and the information stored with the results in case of future query. In reality, this is prohably easier to put into practice than would seem at first sight. 

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