Laboratory systems audit

Based on the above items listed for CRO audits, the laboratory systems audit should assess if the laboratory participates in routine external quality assessments, whether sample handling is adequate and transparent and the risk of mix-ups is minimized. Proper documentation should be available for all sample movements and adequate space at refrigerators/freezers/cold rooms is mandatory. Refrigerators/freezers/cold rooms must be temperature-monitored, connected to an alarm system, be maintained, cleaned and calibrated as required. 

Changes take place in the laboratory system to take into account customer feedback and/or laboratory and office feedback. This could be after the completion of the work or as a result of the internal audit. Management review will evaluate the whole system and provide resource to enable changes to take place, e.g. 

The assessment of project activities may include performance and systems audits, data quality audits, peer review, PE samples, as appropriate for a given project. Assessment enables project personnel to identify field and laboratory problems or variances from the project scope and to implement timely corrective action. The findings and response actions originating from assessment activities are documented in reports to management. 

The performance of the laboratory QC system is assessed through internal and external systems audits. Laboratory QA section performs internal audits and identifies the weaknesses of the quality system or the deviations from approved internal procedures. The state, the EPA, a client or any other body that oversees the quality of laboratory work conducts external audits as part of initial and ongoing laboratory... 

Alternatively, the quality audit may be conducted on-site. Again, the audit can be as extensive as a comprehensive GMP, Good Laboratory Practice (GLP), or Good Clinical Practice (GCP) systems audit that reviews all regulatory requirements for strict compliance, or simply a visit to ensure that... 

Today regulatory authorities accept the principle of using a computer system for laboratory management and for controlling release of product to market, and it has now become the norm for laboratories to use LIMS. Regulatory inspections of laboratories often audit the use of LIMS. Typical areas of regulatory interest include ... 

In the majority of clinical trials, external (central) laboratories are contracted to analyze biological samples which are acquired during the clinical trial. Laboratory results are often critical, for example primary efficacy data, and, therefore, warrant systems audits in laboratories. 

Audit A systematic check to determine the quality of some function or activity. Two basic types are performance audits and system audits. Performance audits involve a quantitative comparison of the laboratory s results to those of a proficiency sample containing known concentrations of analytes. A system audit is a qualitative evaluation that normally consists of an on-site review of a lab s quality assurance system and physical facilities. 

In addition to performance measurements by those working in the laboratory, periodic audits by knowledgeable people independent of the location or activity should be arranged to enable a deeper and more critical appraisal. Top management should review the management system and its... 

As ISO/IEC 17025 does not cover some of the system elements, your laboratory should therefore be subject to audit against the relevant requirements of ISO/TS 16949. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

Peer review This involves setting up mechanisms for mutual review of dmg regulation systems. It serves as a means of external auditing, whereby the performance of one agency can be compared with that of others. Systems for international peer comparison of QC laboratories are one example. Proficiency tests are performed by the participating laboratories in such a way that each laboratory learns how well it is performing in comparison with the others. 

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

Automated electronic data capture systems have become increasingly important in the laboratory. They have improved the ease of manipulation and reporting of chromatography data. A regulatory requirement is that these systems must generate a permanent audit trail of the parameters employed in the collection and analysis of those data. 

The electronic data capture systems that have become commonplace in the research and analytical laboratory allow rapid and efficient acquisition, manipulation, and reporting of vast amounts of scientific data. In addition, they have provided a means to generate a permanent audit trail which describes the conditions under which a... 

When you start working across the Internet, the chromatography data system becomes an open system and the FDA rule requires controls. Using FDA s definition of electronic records, the laboratory chromatography data system generates electronic records. Based upon the definition, laboratories will need to consider more than just the raw data tiles. One must also include the method tiles, mn sequence tiles, and the integration parameters used for the data analysis. The need for a comprehensive audit trail is a critical component of the FDA regulations. The audit trail is an electronic record and is subject to the same controls. 

A laboratory must have a defined quality management system, which is described in the Quality Manual. The procedures for auditing and reviewing... 

It may seem unnecessary to have audits especially when there seem to be so many different types of audit. However, in spite of all of the documented procedures there are problems that can arise in analytical laboratories due to changes in staff, procedures, equipment, sample type and number of samples. For a laboratory to provide a consistent standard of quality in the face of all of these regular operational changes, Quality Audits need to be carried out. Audits will identify the problems which are expected to emerge, and provide a system to put them right. 

Quality Audit is the only option available to them. It is therefore vital that, to ensure standards of quality are maintained, a laboratory must operate its own internal audits to test its quality management system. If the internal system of audits is not operating adequately, external assessment visits are liable to be traumatic experiences, awaited with trepidation and producing unexpected and embarrassing nonconformities in several areas of operation. 

This chapter describes how a laboratory manages the quality of its work. In Chapter 2, an indication was given of the Standards a laboratory might select. This chapter compares and contrasts such Standards and sets out how a laboratory chooses the most appropriate Standard to demonstrate the quality of their work. Many components make up a management system and each one of them is described, including the purpose and conduct of audits, internal and external. Examples are given of some of the documentation required. 

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