Pharmaceutical Industry Software Quality Assistance & Assessments to PDA Technical Report 32
"Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations"
Performance Based Audits, and Assistance for the Pharmaceutical Industry
Audits of Suppliers providing Computer Products and Services for Regulated Pharmaceutical Operations have seen dramatic increases in the last decade. This increase has added significantly to the burden of both the Pharmacuetical Customer and Supplier alike. This has obviously also led to a concern of the industry Regulators as the scope of needed assessments substantially increased.
In addition to the burden of the growing number of audits, the lack of consistency between the various audits performed, concern for auditor quality, and unecessary duplication of efforts led to the development of a consistent means of performing such audits. This means is the Pharmaceutical Industry Software Quality Assistance & Assessments to PDA Technical Report 32, "Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations"
The Pharmaceutical Industry including Regulators of that industry (e.g. US FDA) understand the audit focus of this program must be to the actual execution of activities (i.e. processes and procedures) that affect the reliability, safety, and performance of the computer based product. Until recently, the focus in the Pharmaceutical Industry was on programmatic or process issues rather than the actual performance. The strong Integrity Solutions performance based audit program developed several decades ago for other regulated industries is the effective means for meaningful assessment of supplier technical and quality adequacy affecting performance, safety, reliability, and commitment compliance for the Pharmaceutical Industry.
Utilization of PDA Audit Process Model and Enablers
The Integrity Solutions Group process is completely responsive to the pharmaceutical industry audit (PDA) practice by use of a structured audit Process Model with enablers (templates and tools to aid in audit execution, collection of data, and reporting of results).
The Process Model consists of a six-step process for audit execution. The Integrity Solutions Group qualified auditors accomplish each of the steps represents a collection of activities, for pharmaceutical customers and pharmaceutical suppliers. A brief summary of the steps follows:
Related Services for the Pharmaceutical Industry
Related quality services for the industry, includes but is not limited to:
Experience, Competence, Certifications and Staff Skills
The experience, competence, certifications, and staff skills include:
Software Quality, Engineering, Quality Assessments, Test, Consultant, Assessor/Auditors for Software, Accreditation, Registration.
Business experience of our staff includes being executive officers of consulting engineering and quality firms for decades, decades of experience in engineering management, electrical, instrumentation and control; building automation, assessment and quality demonstration for critical equipment for automotive industry, the pharmaceutical industry, technical and quality training for utilities, manufacturers, laboratories, industrial firms, and business.
Consequently, our team is able to bring specific insight into the proposed assignment, very appropriate to your laboratory. It is not anticipated that others would be necessary to assist in our effort which is likely to occur with technically immature professionals. A brief summary type resume for one of our leaders is available on this site.
Back to the Integrity Solutions Group, Inc Main Page