Ongoing Operational Compliance

Maintenance of the LIMS validation status requires a suitable infrastructure to be in place. This infrastructure will consist of a LIMS manager and appropriate SOPs. The LIMS manager will be responsible for controlling any changes to the LIMS interface, analytical equipment interfaces, LAN/WAN architecture, LIMS functionality and the data held within the database. 

The LIMS manager is typically responsible for the daily administration of the entire LIMS (core database, LIMS servers, peripheral devices [e.g., printers, user PCs, etc.], networks). The manager must respond to user requests and problems in agreed-on timescales as he or she is providing a service to the laboratory. The duties include 

The LIMS change control system must record 

Where a change is required to the LIMS hardware due to the failure of a component, there are two possible scenarios (1) The failed component is no longer available and a new design of the part must be installed. In this case, a DQ exercise will be required to assess the effect on the rest of the LIMS, followed by the normal testing approach. (2) The component is a standard offering from the supplier and is therefore a like for like replacement. In this case, simple testing of the functionality of the replaced component is all that is required. 

The change control system will be utilized in the maintenance phase of the LIMS lifecycle however, the level of details of the review and the rigor of the testing should be the same as was used in the original validation process. The testing must therefore be carried out by competent qualified personnel, and the records of the testing retained as part of the LIMS validation support documentation. 

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Appropriate documentation for ongoing operation and maintenance, and to demonstrate compliance with applicable regulations and codes... 

Eaton, D. L. Smith, T. H. Clements, T. L. Hodge, V., "Issues in Radioactive Mixed Waste Compliance with RCRA Some Examples from Ongoing Operations at the Idaho National Engineering Laboratory," Idaho National Engineering Laboratory, Idaho... 

In addition, the implications of the FDA regulation on electronic records and electronic signatures (21 CFR 11) need to be carefully understood. The regulation not only affects computer systems and their suppliers and integrators but also the organization in which the system is implemented. These requirements must be met in both implementation and the ongoing operation and maintenance of computer systems. 21 CFR 11 also affects systems that are taken out of daily operation (decommissioned), as they would normally contain important GxP electronic records that need to be preserved. Both the validation approach and 21 CFR 11 compliance is thoroughly desaibed in later chapters of this book. 

Ongoing support and integrity checks Validation maintenance— operational compliance... 

RCRA incinerator regulations include adrninistrative as weU as performance standards. Administrative standards include procedures for waste analysis, inspection of equipment, monitoring, and facihty security. Steps needed to meet adrninistrative standards are outlined ia the permit apphcation performance standards are demonstrated during a trial bum. Trial bum operating conditions are included in the permit to assure ongoing compliance with the performance standards. Performance standards include destmction and removal efficiency (DRE), particulate emissions limits, products of incomplete combustion emission limits, metal emission limits, and HCl and Cl emission limits (see Exhaust CONTROL, INDUSTRIAL). 

Operation and Maintenance account for one in three FDA Warning Letters observations related to computer systems. The majority of these are for data integrity and system security. Many observations are examples of bad practice and highlight the need for ongoing compliance activities... 

The safety policy statement must be practical and achievable. Tangible objectives should be set by the policy. The policy should also list practical ongoing steps that will ensure compliance, and it should be written in such a way that it is understood by all. Ongoing briefing sessions should be in operation to ensure that everyone understands the gist of the policy, which should be featured on the company website as well as in the safety handbook, etc. 

Operation manual, warnings, etc. and Measures adopted to ensure ongoing compliance. 

Procedures for the ongoing assessment of compliance with the objectives set by the operator s major accident prevention policy and safety management system... 

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