Audits definition

Audit Definition (ANSI). To conduct an independent review and examination of system records and activities in order to test the adequacy and effectiveness of data security and data integrity procedures, to ensure compliance with established policy and operational procedures, and to recommend any necessary changes. 

To distinguish between a review and an audit, some definitions will be provided. A review is a critical examination or evaluation of any operation, procedure, condition, event, or equipment item. Reviews can take many forms and be identified as project reviews, design reviews, safety reviews, pre-start-up reviews, and so on. The following discussion of the review process will deal with project reviews associated with capital projects and focus on the area of process safety. 

Audits by definition are conducted on-site. An audit may be conducted using a variety of approaches and guides, but in general involves a team that gathers data through interviews, observation, and review of documentation. The team usually includes at least two people depending on the complexity of the facility or processes under review, tWs may expand to as many as five or more. 

Another link exists between the PIF concept and the sociotechnical assessment methods described in Section 2.7 The checklists used in the TRIPOD methodology are essentially binary questions which evaluate whether the sets of PIFs making up each of the general failure types are adequate or not. The hierarchical sets of factors in HRAM are essentially PIFs which are expressed at increasingly finer levels of definition, as required by the analyst. The audit tool which forms MANAGER also comprises items which can be regarded as PIFs which assess both management level and direct PIFs such as procedures. 

The advantages to using MSDSs for chemical inventories are that MSDSs are publicly available and required by law. There is no extra cost or labour needed to supply them. The limitations to using MSDSs as a source of inventory data are that currently, in the United States, a standardized reporting format is not mandatory. MSDSs are not verified or audited and MSDS information can be incomplete and/or inaccurate. In addition, OSHA s definition of hazard does not include the broader scope of hazard used in green chemistry. Therefore, chemicals that are potential hazards from the green chemistry perspective but are not defined by OSHA as hazards, are not required to be identified on a MSDS. 

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. 

The quality assurance unit (QAU) performs the quality assurance audit. This task is ongoing throughout the study and is the reason for the existence of the QAU. The QAU is the person (see definition of "person" in Box 7.4) designated to perform the quality assurance duties. Thus, the QAU inspects the study to assure integrity and that problems are brought to the attention of the study director. This unit also determines if unauthorized deviations from protocols and SOPs occurred and reviews the final report for accuracy. 

Litecki CR, McEnroe JF. EDP audit job definitions How does your staff compare Internal Aud 57-61, April 1981. 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

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. 

The International Standards Organization (ISO) definition of audit is Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. The bottom-line goal of the software developer audit process is to allow you to assess the developer s quality assurance (QA) system. 

Definition of roles and responsibilities for corrective action plans Standard operating procedures governing corrective actions Auditing frequency and general access to site records Change control... 

A quality audit has been defined as A systematic, independent examination of a manufacturer s quality system that is performed at defined intervals and sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives 21 CFR 820.2 (t). Another definition is Quality Audit A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives (International Organization for Standardization/American Society for Quality Control). 

There are several reasons why a quality system must be fully documented. Firstly it is a pre-requisite of most quality standards. Secondly, in most laboratories it would be impossible to accurately remember and hence communicate all of the analytical methodology and quality management procedure to staff. This would lead to the quality system becoming compromised due to slalT turnover. Thirdly the process of audit (see Section 5.1) requires a precise definition of the planned quality system. This is provided by the documentation. 

The definition of supplier validation activities and documentation should be embedded in contractual agreements. In addition, suppfiers should agree to potential inspection by GxP regulatory agencies and Supplier Audit by pharmaceutical and healthcare companies. Supplier Audits can be conducted by the pharmaceutical or healthcare company s own personnel or, if this would compromise the supplier s commercial interests, by an independent software quality assurance auditor, consultant, or validation expert employed by the pharmaceutical or healthcare company. Auditors must be suitably qualified, for example by independent certification by examination to the quafity system standards such as ISO 9001 2000. Suppfier Audits are discussed in detail in Chapter 7. 

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 validation was performed according to the Roche Computerized System Validation Policy and Guidelines. This comprised the definition of a Validation Plan, the performance of the planned activities, and the creation of a Validation Report. In addition, the project was accompanied by external consultants providing knowhow regarding the validation-specific aspects of the development, including the management and auditing of the software developer. The scope of the validation activities was defined by GMP Analysis (also known as a GMP Assessment). The system... 

It is important to preserve or translate as much of the original form and format of the data as possible, and that includes metadata. A database can contain a tremendous amount of metadata, such as audit trail information, electronic signatures, relationships between database tables, definition of field characteristics, etc. It is necessary to consider this metadata as part of the data set failure to do so could inhibit searchability and reporting after migration, make modification of old records problematic, or possibly even result in loss of the integrity of the records. Validation tasks associated with data migration must be geared to demonstrate that neither of these circumstances prevails. 

Audits are powerful tools for understanding if data entries are completed as intended. Reported data reviews with those who entered the data can quickly determine if the data was properly reported and the correct definitions were used. 

In September 2003, a new guidance document came out, which was in line with the overall risk-based approach of the FDA. It narrowed the scope of Part 11 to those records explicitly required by predicate rules. Furthermore the guidance stated that until Part 11 is reworked, enforcement discretion would be applied to certain aspects of Part 11 concerning validation, audit trail, and electronic copies and archiving, as long as predicate rule requirements are met. It also indicated that a risk-based approach would be suitable to evaluate which measures are necessary for complying with Part 11. As will be discussed further below (see section Definition of Electronic Records ), this applies mainly to audit trail and electronic copies, and archiving. 

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