Audit checklist systems

The effectiveness of a QA-related independent Part 11 audit is dependent on the checklist or audit plan utilized. Here, provided as a model, is a two-part audit checklist. The depth of the evidence and support required is dependent on the results of the risk assessment All high-, medium-, or low-risk systems should be subject to the same general questions. 

Since current quality system models employ a systems approach, an audit checklist that is organized by subsystem may be helpful, as described in Table 5. The form would include appropriate document control information such as form... 

Company Name] Quality System Audit Checklist ... 

ELECTRONIC SIGNATURE AND ELECTRONIC RECORDS AUDIT CHECKLIST FOR A CLOSED SYSTEM... 

All stages Management and safety system audits Checklists Feedback from workforce... 

The key to the process is to understand the system that is being proposed. It is good practice for the auditor to spend time reviewing the User Requirement Specification and the system descriptions and understanding of what software categories exist for the proposed system. This should be followed up, with the postal audit checklist. This will also provide valuable information to enable the auditor to plan the audit. Available information should be used to customize the audit checklist to address the specific issues that are relevant to both the supplier and proposed project. Consider, for example, a system that includes hardware and software, where some of the software is custom, other parts are configurable and yet others are part of a standard package. The auditor will need to establish how each part of the system will be developed, and how the build phase will be controlled. There may even be more than one supplier. The auditor would need to split up the main elements and examine how each part of the system will be built. 

The standard software packages and the cnstom elements of the system wiU reqnire a similar review against the standard audit checklist. It is important to use the checkhst as an aid to planning the audit, not to drive the audit. Remember, if you fail to prepare —prepare to fail. 

The model checklist is divided into two parts a general list of Part 11 requirements and a specific audit checklist (in this case, for closed software systems not utilizing biometrics, the most common application). 

This audit checklist should be considered as guidance only for the preparation of suitable checklists for application in your museum or gallery. Safety audits are usually evaluated by using a system of points scoring . Answers to questions are assessed by the person making the report and compared to a known or reasonable standard. For example, responses to the first question, Is the safety policy appropriate and up to date , could be ... 

These checklists may be used to indicate compliance with standard procedures. As indicated above, a checklist is easy to use and can be applied to each stage of a project of plant development. A checklist is a convenient means of communicating die minimal acceptable level of liazard evaluadon diat is required for any Job, regardless of scope. As such, it is particularly useful for an inexperienced engineer to work tlirougli die various requirements in the checklist to reach a satisfactory conclusion. However, a system checklist should be audited and updated regularly. 

In order to audit effectively studies with electronically generated data, QA should create a special checklist or add electronic issues to a current checklist. The checklist should include items such as ensuring that the computer system in use is current and validated and that necessary maintenance is documented. 

The commonly used management systems directed toward eliminating the existence of hazards include safety reviews, safety audits, hazard identification techniques, checklists, and proper application of technical knowledge. 

Develop recommendations to improve the management system to prevent the existence of safety hazards, including training, checklists, inspections, safety reviews, and audits,... 

This optional attachment is used to promote continuous improvement of the entire safety management system. It is a checklist for anyone to use as a guide when auditing incident investigation activity. The facility from which this example was derived includes a similar checklist for each safe work practice at the site. 

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. 

An inventory of systems and knowledge, of which one is GMP-critical, must be maintained and available for inspections. An MHRA preinspection checklist has this as one of its opening topics. The availability or otherwise of this information is a clear indicator of whether management is in control of its computer systems validation. The use of an inventory need not be limited to inspection readiness it could also be used for determining supplier audits and periodic reviews, etc. Many pharmaceutical and healthcare companies use a spreadsheet or database to maintain this data. Where a site s inventory is managed between a number of such applications (perhaps one per laboratory, one for process control systems, one for IT systems), care must be taken that duplicate entries are avoided and, equally, that some systems are missed and not listed anywhere. It should be borne in mind that where spreadsheets and databases are used to manage an inventory, it should be validated just like any other GxP computer application. 

The first task, hazard identification, is crucial in process system safety analysis, because the effectiveness of the other two tasks depends on it. The traditional methods for identifying hazards during the 1960 s (including process reviews , codes of practice , checklists , and safety audit ) were no longer considered adequate in the 1970 s. There was a need for a technique which could anticipate hazardous problems, particularly in areas of novelty and new technology where past experience was limited. 

An audit is a detailed check of the Quality Assurance System by IT specialists. An audit is carried out on the basis of a SOP containing a checklist with the respective questions. Audits conducted by other companies may be referenced. (Supplier audits are discussed in more detail within Chapters 14 and 15.)... 

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