System Audits

It would also have an audit system to confirm that lessons learned were indeed captured. 

Despite these potential benefits, there are possible problems associated with the use of generic safety audit systems. Questions that need to be considered in the case of such standardized audits include ... 

Procedures Do Not Correspond to the Way the Job Is Actually Done. Procedures are often developed when a system is first commissioned and are seldom revised to take into account changes in the hardware or the operating regime. In addition, procedures are often not written on the basis of a systematic analysis of the task as perceived by the workers or other personnel who have to use them. The remedy for this is to make sure that individuals who are going to use procedures are actively involved in their development. In addition, effective updating and auditing systems need to be in place to ensure that procedures are correct, and available to the persons who need them. 

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. 

Only four of tiie 10 countries— Australia, Estonia, Malaysia and the Netherlands —operate an audit system to evaluate the GMP performance of inspectors or the inspectorate. Auditing of distribution-channel inspection is carried out by Malaysia, the Netherlands, Uganda and Venezuela. In Australia, GMP audit is both internal and external, and involves an extensive review of process and technical approach. Further training, advice, revision of job description, legal proceedings and dismissal of inspectors are some of the means used to correct any weaknesses observed. 

Vendor evaluations and audits System design, development, build Software review... 

A supplier will need to demonstrate structured working methods with full and auditable system documentation. The chosen supplier will also be expected to provide qualified and trained resource with appropriate knowledge of validation methodology and experience in providing solutions for GMP-regulated applications. 

An important objective of ongoing evaluation is to uphold an auditable system of validation documentation and ensure a controlled, fully documented record of any activity that may affect the validation status of the computer system and the computerized operation it is part of. 

Reason for the audit and type of audit being performed, (e.g. mock FDA audit, documentation audit, systems audit). 

Regnlarly audit systems to verify that their specihcations are still current and that they perform as intended. 

Based on the above-described trial-related audits, systems audits can be composed of such core audit elements and enriched by additional elements to form a systems audit. In general, the scope of any study-related audit can be broadened into a systems audit. The following paragraphs describe selected systems audit further information is available in literature (DGGF, 2003). 

While most chemicals companies buy in to the Responsible Care programme, what is being looked for here is the employment of, and a particular intention to work to, a recognised environmental management system such as ISO 14001, the European Eco-Management and Audit System (EMAS) or a management verification system such as that run by the US Chemical Manufacturer s Association. While it is expected that the company will have a significant proportion (>25%) of its production sites certified, a yes score may be achieved with a lower proportion if there is evidence that the company shows a continuous upward trend. 

Occupational illness the report includes an article on BASF s worldwide Occupational Medicine and Health Protection programme and auditing system, and describes the use of an Industrial Hygiene Exposure Assessment procedure at 23 sites in the USA, Canada and Mexico. No data is presented. 

The audit system is overseen by the Responsible Care Review Committee. Two levels of audit are described. Internal audits are reviewed annually and top executives carry out annual inspections of all plants and laboratories. 

Mention is made of the Responsible Care Supervisory Board, which helps develop strategies for HS E matters, and monitors compliance, and of the introduction in 1998 of a new Responsible Care Audit system. There is also good evidence that internal auditing has been taking place. 

DESIGN REQUIREMENTS FOR AUDIT SYSTEMS 1132 3.2.2. Other Data-Collection Methods 1145... 

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