Independent audits

Knowledge that the declared intentions are actually being followed. (This may be gained by personal assessment or reliance on independent audits.)... 

If there are no existing measures of PSM and ESH, do not panic Use the results of an independent audit of the management systems conducted before and after the pilot study or use the results of existing audits. 

Some deficiencies in the integrated systems may be seen at once others will be visible only after project resources have been withdrawn and the system is self-supporting. It is important to examine the integration straight after installation and a few months later. These reviews should draw on the results of the independent audits and should involve staff from the pilot... 

Because of the complexity of computer hardware and software and because of the intricacy of a risk assessment, the FDA has to all intents and purposes adopted an indirect regulatory posture. Regulated companies are informally urged to conduct independent audits of Part 11 compliance, utilizing in-house or consultant expertise. The agency can then review the details of the audit report and the credentials for experience, expertise, and independence of the auditor. Follow-up investigation of speciflc points can then be laser-focused on specific areas of concern. 

A specification agreed with a supplier is not a guarantee that all deliveries will fully comply with it and arrive in full and on time. A Certificate of Analysis adds confidence and if the supplier is accredited to the ISO 9000 series or a national equivalent it shows that the quality systems have been independently audited and found to be acceptable. However, there is no substitute for regular performance reviews, backed up as appropriate by audits of the manufacturing facilities and quality systems (including incoming raw materials). This is a very onerous and time-consuming exercise, well beyond the resources of most soft drink manufacturers. 

Audit Report. A report of an independent audit of the computer validation process by an internal auditor (i.e. Quality Assurance) should be included with the summary report to management. The audit should compare the SOP and the initial parts of the protocol (what the system should do) with the test plan results (what the system actually does) and the summary report conclusions. 

In order to prepare for a PAI, the company usually sets up an independent audit of the facilities well before the formal PAI. This audit, usually carried out by the company s own Quality Assurance/Regulatory Compliance groups, often assisted by... 

Outcomes independently audited, blind to study period... 

Review the final clinical report, and sign and date the signature page after review Allow an independent audit and/or inspection of all study documents and facilities Agree to the publication policy Agree to the sponsor s/CRO s ownership of the data... 

Bohaychuk W, Ball G. 1999. GCP compliance assessed by independent auditing international similarities and differences . In The Clinical Audit in Pharmaceutical Development, Hamrell M (ed.). Marcel Dekker New York. 

Program Guidance Manual, 2006), stating Clinical trial quality assurance units (QAUs) are not required by regulation. However, many sponsors have clinical QAUs that perform independent audits/data verifications to determine compliance with clinical trial SOPs and FDA regulations . 

If an independent audit was conducted, begin by providing the investigator with the letter or certificate of results. Then provide the report that states the standards or criteria and the reasons for acceptance. Finally, if requested, make available the detailed evidence upon which the report is based. 

A code user may rely on the results of an independent audit of code as long as that audit followed appropriate steps as outlined. 

Table 3.19 shows that the early activity mainly occurred in the USA and the UK across a number of different industry sectors. Traidcraft, established in 1979, was the first business in the UK to develop voluntary social accounts and to publish independently audited social reports. 

It is not surprising, then, that analysts would compare the accounting profit rates of firms in the industry with those of firms in other industries (301,457). The ready availability of publicly reported and independently audited data and the widespread use of these measures by companies themselves invites such comparisons. By these conventional accounting measures, the pharmaceutical industry looks very profitable compared with other industries (301, 457). But these comparisons are limited in two important ways. 

Motivation is another matter. Because the estimated ratio of preclinical cost to total R D cost cannot be verified without an independent audit of cost accounting information, a company that understood the use to which the data would be put and with a strategic incentive to overestimate the preclinical ratio could do so without potential for discovery. 

The laboratory should be accredited for the type of testing requested and be independently audited on a regular basis. Suitable quality control requirements are enforced by the United Kingdom Accreditation Service (UKAS) and are required to comply with ISO 17025. 

The role of this council is essentially to provide ideas and propositions concerning the great scientific problems, as well as an external and independant audit, ready at any moment to notify the General and Scientific Management of any new discoveries or advances likely to modify the direction of our research. 

Self inspections should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may also be useful. 

Packaging and labelling operations are often performed after the release of the bulk product and in accordance with specific requirements of different trials. These operations are of paramount importance for the integrity of clinical trials. In this respect, self inspection or independent audits, as referred to in the Community... 

Bohaychuk W, and Ball G (2000), GCP Compliance Assessed by Independent Auditing. International Similarities and Differences, In The Clinical Audit in Pharmaceutical Development, edited by M Hamrell. (Marcel Dekker publishers)... 

---