Operating Procedures users

Validation test environment including hardware, software System security including passwords, network rights, functional security, physical security, modem access and virus protection Validation test environment including related documents, along with standard operating procedures, user manuals, and system development/ maintenance and documentation Validation assumptions, exclusions, and limitations Responsibilities matrix Validation data sets Acceptance criteria Expected results Execution of the validation plan Resolution of errors Documentation Training records... 

Validation test environment including related documents, along with standard operating procedures, user manuals, and system development/maintenance and documentation... 

The ongoing provision of easily accessible documentation to support training including Standard Operating Procedures, user guides, video tutorials and application help functionality. 

There is a variety of formats for documenting the analysis. One example appears in Figure 31-1. When final, the hazard analysis and recommended practices can become part of an operating procedure, user manual, or training program. 

Standard operating procedures (SOPs) are step-by-step job instructions which can help workers perform their jobs safely and efficiently. When the end users are involved in their design, SOPs can provide a basis for arriving at a method of work agreed-to by different shifts. In this sense, SOPs can be used to develop training programs and specify measures of competence. Because of the importance of SOPs in the work situation, a systematic framework is needed to enable the design of reliable procedures which are acceptable by the workforce. 

One of the major undertakings during LIMS implementation is user training, which should cover not only the LIMS itself but also the standard operating procedures (SOPs) that govern use, administration, training, and other aspects of the LIMS. The training should be conducted on the test system... 

Appropriate user procedures must he followed. Standard operating procedures (SOPs) should provide user guidance and control and should be rigorously followed. 

The purpose here is to verify the standard operating procedure at the user s premises. The procedures analyzed include ... 

FIGURE 1 Validation phases. URS user requirement specification FRS functional requirement specification DQ, IQ, OQ, PQ design, installation, operational, and performance qualifications SOP standard operating procedure. 

Once satisfied that the instrument is operating in accordance with its own specification, the end user should ensure that it is fit for purpose for the applications intended. This step is called Operational Qualification, OQ. This process would include writing the Standard Operating Procedure (SOP) and training staff in its use. Further testing may be required to ensure that the instrument performance is in accordance with National and Corporate standards if not carried out in IQ. Frequently, instruments are used with accessories or sub-systems, e.g. sipper systems or other sample presentation devices. Challenge the analytical system with known standards and record what you did. It is necessary to ensure that they work in the way intended and that documented evidence is available to support their use. 

Poor operator interface design induces errors and inefficiency among even the best-trained operators, especially under conditions of stress, time constraints, and/or fatigue. Although labeling (e.g., user documentation) is extremely important for good performance, even well-written instructions are cumbersome to use in conjunction with actual operation. In addition, it is difficult to write coherent documentation that describes awkward operating procedures. 

Operator instruction Maintenance procedures User manuals Training materials Validation documents/package Supplier project quality plan... 

Operational Procedures operator commands, override control, process monitoring, parameter modification, load scheduling, startup and shutdown, fault-finding instructions, user manuals and documentation... 

Operations personnel must be able to use all operating procedures before the computer system is cleared for live use. User Standard Operating Procedures (SOPs) can be used to confirm system fimctionality. Any competencies required to conduct these tests, including training on user SOPs, should be given and recorded before testing begins. 

Standard Operating Procedures for managing security access (including adding and removing authorized users, virus management, and physical security measures) must be specified, tested, and approved before the system is approved for use. Topics to be covered include the following ... 

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]... 

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

For combined systems, vendor-updated software revisions may be critical, especially if the updated version supplied by the vendor will have an effect on the interface between the vendor s and the user s software (e.g., if the meaning of a macro command has been changed). The user should obtain information from the vendor on how the updated version may affect the interface. The user should also test his or her software after it has been integrated into the vendor s updated standard software. More details are found elsewhere about Standard Operating Procedures (SOPs) for developing and validating simple as well as complex applications software developed in the user s laboratory. ... 

For a computer system in an analytical laboratory, OQ can mean, for example, verifying correct communication between the computer and other hardware. As part of the product documentation, vendors should provide operating procedures for the tests, limits for acceptance criteria, and recommendations in case these criteria cannot be met. The documentation should also include algorithms for critical calculations and procedures on how to verify the algorithms in a user s environment. If the user finds the tests recommended by the vendor inappropriate or insufficient, the user can design and perform other or additional tests. 

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. 

Standard Operating Procedures (SOPs) must be written to cover operational activities. The SOPs should be written by personnel knowledgeable in the low-level detail of LIMS, and should be detailed enough for the user to work without reference to other personnel or documentation, or memory. By using the OQ as a means of formally testing the SOPs, any issues of detail should be identified. The first version of the SOPs must be authorized and issued prior to the start of Performance Qualification (PQ). 

In the test phase, user acceptance tests were performed. The goal of these tests was to verify whether the completed system was performing according to the user requirements dehned in the prequalihcation phase. Successful test completion was documented in the Vahdation Report, confirming that the system had been validated for use in daily business. Also included in this phase was the development of various operating procedures. The activities carried out are summarized below. 

Write user in- Prepare standard operating procedure... 

Reference Materials Many vendors supply certified standard reference materials which address either a single instrument or a group of instruments. As these materials are ejq)ensive, it is often advisable to perform only the primary tests with these materials and perform secondary tests with a stable and well-split material supplied by the user. For best relevance, the size range and distribution t e of this material should be similar to those of the desired application. It is essential that the total operational procedure be adequately described in full detail (S. Rothele and W. Witt, Standards in Laser Diffraction, 5th European Symposium Particle Char., Nuremberg, March 24—26,1992). 

This summary of use and portfolio of evidence forms the basis of the standard operating procedure for the clinical use of the test, the core of the educational material for users of the service, and the basis for conducting the audit. 

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