Purposes of Auditing

Auditing can serve the need of evaluating and verifying safety, health, and environmental compliance. The desire is to measure compliance with specific regulations, standards, or conqiany policies. Some of the benefits of auditing programs include  

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Entry in accordance with Sec. 792.15 for the purpose of auditing test data or inspecting test facilities is denied. Persons who violate the provisions of this part may be subject to civil or criminal penalties. .., legal action..., or criminal prosecution. 

General requirements The purpose of audit monitoring is to provide the information necessary to determine whether or not all of the directive s parametric values are being complied with. All parameters set in accordance with Article 5(2) and (3) must be subject to audit monitoring unless it can be established by the competent authorities, for a period of time to be determined by them, that a parameter is not likely to be present in a given supply in concentrations that could risk of a breach of the relevant parametric value. 

The common purpose of auditing and inspecting is to find and eliminate hazards. 

Company has a system in place for the purpose of auditing drivers logs. 

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

Audits of practice against procedure or policy should be recorded as they are observed and you can either do this in note form to be written up later or directly onto observation forms especially designed for the purpose. Some auditors prefer to fill in the forms after the audit and others during the audit. The weakness with the former approach is that there may be some dispute as to the facts if presented some time later. It is therefore safer to get the auditee s endorsement to the facts at the time they are observed. In other types of audits there may not be an auditee present. Audits of procedure against policy can be carried out at a desk. You can check whether the documents of the quality system satisfy all the clauses of the standard at a desk without walking around the site, but you can t check whether the system is documented unless you examine the operations in practice. There may be many activities which make the system work that are not documented. 

Large and complex projects will be monitored as the expenditure proceeds while smaller outlays will be looked at after completion. The purpose of such monitoring is to provide a comparison of actual expenditure with that estimated when the project was sanctioned. The accounting or internal audit departments will normally carry this out. However, for a sensible comparison to be achieved it is essential that the planned expenditure demonstrated in the project be classified in the same way that the actual expenditure will be analyzed. While somewhat obvious, this is an area where very great difficulty is often met in practice, especially where large projects are involved. 

The nature of an inspection will vary depending on the purpose of the audit and the type and size of the facility under scrutiny. Initial audits of a new facility will usually take the longest, as inspectors will want to conduct a full inspection of all aspects of... 

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. 

The point at which data becomes an electronic record should reflect its origin and intended purpose. For manufacturing systems, this may be the initial point of data acquisition and this point would also form the basis for the recording of audit trails for changes to a record. 

As part of the action of signing an electronic record, the purpose of the signature must be identified and be an element of each signed record. In the drag CGMP arena, there are relatively few purposes for a signature and these include authored by, reviewed by, and approved by The execution of an action such as a production step does not require an electronic signature, and can be documented via the audit trail. 

The purpose of the following checklist is to help to determine if a computer system complies with the FDA Rule 21 CFR 21 Part 11 for electronic records and electronic signatures. This audit questionnaire apphes to systems that meet the definition of a closed system as defined in Section 11.3 (b)(4) of the rule and which do not utilize biometrics identification methods. 

Opening meeting agenda—introductions, review of audit purpose and scope, review of audit schedule, discussion of audit logistics, including guide for auditors, special clothing requirements, and location for auditors to work... 

The purpose of the qualification/audit is for the sponsor to investigate the standard practices of the contractor. Quality as well as technical capabilities should be evaluated. One should determine where the test article will actually be stored, the department that will conduct the in-life portion, make an assessment of procedures (SOPs) for dosing, identify differences between the sponsor s general practices and the facilities operating procedures (proto-col/study-specific procedures (SSPs), and assess the process of interim data exchange and the method of reporting of SOP and protocol deviations to the study director and the sponsor. 

Also, we shall see in section 3.3., Reason s proposal to use an auditing tool of a standard set of faulty management decisions clearly aims only at the Monitoring purpose of near miss reporting, perhaps also somewhat at the purpose of Alertness , but certainly does not contribute to Modelling , i.e, to understanding how the development from left to right in his model can occur. 

The purpose of inventory management is to maintain the integrity of data to ensure that it accurately reflects the physical inventory (location of compound, amount available, and condition). Inventory management should be associated with all transactions such as archiving, order fulfillment, and sample removal so that the inventory always reflects samples in real time. Inventory management should also allow system auditing and error correction. 

The purpose of this visit is to retrieve all remaining supplies and prepare the site for a potential study audit. An appointment is scheduled with the investiga-... 

The sponsor is responsible for securing agreement from all involved parties to ensure direct access (see 1.21) to all trial related sites, source data/ documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities. 

The purpose of a sponsor s audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial... 

Audit trails must be available for the duration of a record s retention period and protected from any form of alteration. It should be possible to establish the current value and all previous values of a record by using the audit trail. Normal working practices (procedural and built-in computer controls) should prevent audit trail content being altered without definitive authorization by a second documented supporting party. Audit trails need to be available with their electroruc records in human readable form for purpose of inspection. 

The purpose of a Supplier/integrator audit is to allow the pharmaceutical manufacturer to review documented evidence of the application of the supplier Quality Management System (QMS) throughout the development of the LIMS package. The Supplier Audit will also confirm that the supplier is capable of delivering the correct standard of software engineering and documentation for LIMS. 

The purpose of production of the technical baselines and underpinning R D requirements is to establish an auditable trail through the LCBL from programme components into how the programme will be delivered. The LCBL 05 was the first programme to attempt this process. 

At study completion, the data manager is responsible for assuring that the data are clean and then prepares to lock the study/close the database. The purpose of locking the study is to ensure that a full audit trail of any changes exists once the study/patients have been unblinded. Database closure marks the end of the study conduct phase and the beginning of the analysis and reporting phase. The standard definition of clean data is ... 

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