Audit document

The final audit report, action plans, progress reports, and any closure report should be retained by the facility based on the facihty record retention pohcy. Typically, these items will be retained until future audit documentation replaces them. In some cases, audit records are retained for the life of the plant. 

The reasoning for the selection of measures must be auditable (documented). 

Once a recommendation has been accepted for implementation, a clear, auditable document trail should be established and maintained. It is the prevailing opinion of many regulatory agencies in the US that any changes in the originally accepted recommendation should be thoroughly documented. If a recommendation is modified in scope or time commitment, or is otherwise not implemented as originally planned, then the basis for this decision should be documented. 

To maintain control of the computer system throughout its conception, implementation, and operational use in a GMP environment, it is required that the computer system application must be validated in a way that will establish auditable documented evidence that the computer system does what it is expected to do. As applicable, this needs to be carried out in conjunction with plant equipment to provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The methodology to achieve this is based on a recognized life-cycle mode. 

Auditable documented records of system application and operational use... 

The OECD Guidelines for National GLP Inspections and Study Audits document serves as a companion document to the Principles and is intended to provide national authorities additional guidance in preparing and implementing their national GLP compliance programs. 

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

Issue interim audit document and audit summary... 

PURPOSE To inform the management and staff of the facility of the reason for the Test Facility Inspection or Study Audit that is about to take place, and to identify the facility areas, study(ies) selected for audit, documents and personnel likely to be involved. 

Issue Interim Audit Document and Audit Summary... 

No Standard Forms to record a donation - an auditable document suffices... 

An X can be placed in the appropriate yes, no, or not applicable box next to a given question. When the audit document has been fully populated, the score that has been calculated by the spreadsheet can be used to communicate the level of the school s performance. All X markings in the yes column can be totaled to arrive at the number of areas in which the school was in compliance, and all of the X markings in the no column can be totaled to arrive at the number of areas in which the school was not in compliance. 

Pre-Audit Facility Visit Develop Audit Manual/Questionnaire Preview Audit Documentation Records Preliminary Document Review... 

The importance of master plans in the technology transfer process is described by MacLennon Troll. While the master plan is specifically described for the technology transfer process as a whole, it is also applicable to the transfer of analytical methods and its use is becoming more prevalent within the industry. The technology transfer master plan describes the transfer strategy for all of the testing methods described in the specifications for the test article(s) of interest. The master plan is an auditable document that will help the health authorities during the preapproval inspection (PAI) to understand the overall transfer process and make... 

Keys to keeping the audit practical and effective are to control the number of questions being asked and to avoid being overly prescriptive. Being too prescriptive simply means asking too many detailed questions rather than allowing flexibiUty to meet the intent of the audit s requirement in a manner that best suits their needs. Keep your audit document simple and straightforward. 

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