Quality assurance auditors

The book provides instant answers to validation engineers, validation specialists, quality professionals, quality assurance auditors, and protocol writers about what to include in validation SOPs and how to enhance productivity. 

After a field inspection is completed, any deficiencies found or recommendations for improvement are discussed with the investigator. This is followed by a written report. The investigator then may append any comments he may wish to make to the report. He signs and dates the report then sends it to his supervisor who signs and dates the report and returns it to the Quality Assurance auditor. 

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. 

The actual training of the analysts at the receiving end of the methods is an area that has received considerable attention from regulatory authorities and internal quality assurance auditors. There are several options to certify analysts to perform the required test procedures. One possibility is to qualify individual analysts on each method, thereby creating a matrix of methods and analysts. Such an approach can become cumbersome as it would involve substantial documentation with respect to training records for individual analysts. Compliance liability could also result if an analyst who was not certified produced reportable GMP data. 

For each document to be produced, indication in the quahty assmance programme description of who should review it and approve it for official release. A description of the project s organizational stmcture which should include assurance of the independence of quality assurance auditors. 

At aity time, a quality assurance auditor or regulatoiy auditor should be able to request and directly receive any items of the set that constitute the most complete and current description of the system and projeet (the current baseline). This set of items should be identical with those currently being used as a basis for ongoing development or analysis, with the exception of woik in progress that has not yet been approved or released. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

J. Patrick McDonnell, B.S.Ph. Senior Compliance Auditor, Department of Biologies Quality Assurance, Fort Dodge Animal Health, Charles City, Iowa... 

This manual provides instant answers for quality professionals, quality assurance managers, auditors, and protocol writers regarding what should be made part of quality manual standards and ISO 9000 standard operating procedures to enhance productivity. 

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. 

Howard Garston-Smith, formerly of Pfizer, has published a book on software quality assurance. It provides a postal audit checklist reproduced in Appendix 7C. If the supplier has already prepared an internal ISO 9000 mapping or an internal audit report on how it aligns to industry standards such as the GAMP Guide, this can be offered as an alternative to the auditor s postal checklist. A reduced postal checklist may be agreed upon, at the very least. Wherever possible, photocopies of actual example documents and test records should be inspected for documentary evidence of validation. Remember that the pharmaceutical and healthcare companies are themselves being inspected for documentary evidence of validation. 

Audits are usually conducted by an audit team and led by a qualified, accredited auditor. Accredited auditors should have completed a certified development program, be accredited under an appropriate standard (ISO 9000 2000 TicklT in this context), and should have conducted a number of qualifying audits. Pharmaceutical and healthcare companies that do not have their own accredited auditors can engage an independent auditor, as we have seen. Names and addresses of accredited auditors can be found in national registers of certified auditors. The International Register of Certificated Auditors is one such register, associated with the Institute of Quality Assurance (IQA). 

Garston-Smith, H. (1997), Software Quality Assurance — A Guide for Developers and Auditors, ISBN 1-57491-049-3, Interpharm Press, Buffalo Grove, IL. 

Prior to establishing any relationship with a contractor, the quality assurance staff of a potential client must audit the contractor s facilities. During this audit, the contractor should be willing to provide a comprehensive tour of the facilities. Following the tour, the auditors need to review all of the contractor s standard operating procedures that may apply to their company s proposed project. In addition, the auditors need to review the quality improvement process being used by the contractor and the results of that process. Any concerns that have been identified during the audit should be discussed with the contractor at that time. 

In this sense. Quality Assurance might be compared to the independent auditors of a company s financial status, who should also, unbiased by any involvement in the company s well-being, deliver their verdict in no uncertain terms. 

Of course, if a firm is ISO 9000 acaedited, this already speaks volumes about its commitment to quality, although the limitations of ISO 9001 to software development need to be clearly understood. These shortcomings have given rise to ISO 9000-3 (TickIT), to which over 1,000 firms have now been accredited however, this is a drop in the ocean when viewed against the industry as a whole. The consistent pattern of commercial success enjoyed by TicklT-accredited software houses is no coincidence and should be used by the auditor as a powerful endorsement of the benefits of a quality-assured process in securing the future prosperity of a firm involved in any way with software development. 

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