Audits/auditing Audit Service Providers

System Overview Supplier Audit (Application Vendor, Service Providers)... 

B.13. Experience of validation process (with other customers, previous Supplier Audits, services provided by supplier, involvement in regulatory inspections)... 

Some companies specialize in providing audits for their clients. These companies are sometimes referred to as Audit Service Providers or ASPs. They have the systems and people in place to conduct a professional audit. The standard reference for meeting ASP requirements is ISO/IEC 17021, Conformity assessment—requirements for bodies providing audit and certification of management systems. The following is from the abstract for that standard ... 

COS Safety Publication COS-2-04, Requirements for Accreditation of Audit Service Providers Performing SEMS Audits and Certification of Deepwater Operations. 

Audit service provider (ASP) An independent third-party organization that demonstrates competence to conduct SEMS audits in accordance with the requirements of this subpart. 

Some companies specialize in providing audits for their clients. These companies are sometimes referred to as Audit Service Providers or ASPs. They have the systems and people in place to conduct a professional audit. 

PDA Technical Report 32. Auditing of Suppliers Providing Products and Services for Regulated Pharmaceutical Operations. International Association for Pharmaceutical Science and Technology (1999). 

Based on technical report 32, PDA has established a third party inspection program in the field of software suppliers. It works like the one described for IPEC s BPE GMP audits. By March 2002, 117 auditors had been certified, and the audit repository center, as the service provider licensed by PDA, lists 22 audit reports [33]. 

Auditing of Suppliers Providing Computer Products and Services 32 1999... 

It is ultimately the sponsor s responsibility to ensure that cGCP is followed in its clinical trials, even though some of the work is contracted out to CROs and other service providers. With regard to analytical laboratories, GCP guidances require that all laboratories have full documentation, data-audit trails, standard procedures, trained staff, archives of samples and data, and routine quality assurance inspections (Prokscha, 2007). If multiple laboratories were to be used, the sponsor would need assurance that GCP requirements were met for every one. In contrast, if a central laboratory is used and all samples are shipped to it, the sponsor only needs to check GCP compliance at that laboratory. 

Pharmaceutical and healthcare companies should reserve the right to audit use of whatever governing procedures are being used. Service providers should be audited just like other suppliers... 

New owner conduct Supplier Audit on divesting organization as external service provider Formal contract of supply required Service Level Agreement established for maintenance and inspection support... 

Ensure that contracts with consultants, services providers, and other third parties require compliance with the company s record policies and permit periodic audits. 

A multitude of external providers are used to deliver services in clinical trials, for example CROs, site management organizations (SMOs) and academic research organizations (AROs). To ensure that they are capable of providing the services in a reliable manner and to the standards expected in compliance with current regulatory requirements, capability audits are conducted at service providers prior to contracting. 

Performing audits of contracted pharmacy providers (e.g., retail pharmacies contracted to provide pharmacy services). This is done to ensure that both the PBM and the managed care organization (payer) are being charged properly by the dispensing pharmacy for what is actually dispensed to the patients. 

Audits can be performed by outside service providers, or by in-house teams made up of people with the appropriate expertise. For example, a TSCA audit team conducting an audit in a manufacturing facility may have a production manager from a facility other than the one being audited, a TSCA Coordinator, and an export specialist. If a lawyer participates in an audit, he or she may be faced with the same issues presented by answering hotline calls, and may need to caution individuals that the company lawyer does not represent individuals. 

An outside auditor should not provide follow-up services to the audit. Such services represent a conflict of interest, with the exception of reviewer-type comments, as discussed above. 

---