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:

  1. Initiation - The focus of this step is to begin the audit process by defining the scope and objectives of the audit and to define the team required for execution of the audit.
  2. Preparation and Pre-work - The focus of this step is audit preparation.
  3. Conduct Audit - The focus of this step is to execute audit per plan.
  4. Observations and Reporting - The focus of this step is to document and verify results.
  5. Decision - The focus of this step is analysis by the end-user.
  6. Follow-up and Close Out - The focus of this step is to close out the audit and prepare for surveillance.

Related Services for the Pharmaceutical Industry

Related quality services for the industry, includes but is not limited to:

  1. Quality Pre-Assessments or "Gap Analysis"
  2. Unique Quality System Development
  3. Quality Documentation Review /Preparation
  4. Post-Audit Supplier Risk Mitigation
  5. Deficiency Resolution Assistance
  6. Quality Executive Overview
  7. Quality PDA Orientation Training
  8. Quality Assurance Management Support
  9. Ongoing Audit Service

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.

  • PDA Certified Auditors for Pharmaceutical Software Supply
  • Registered Professional Engineers
  • Registration Accreditation Board certified Quality System Lead Assessors (QMS-LA) to ISO 9000
  • Certified Lab Accreditation Assessors to ISO/IEC 17025 and ISO/IEC Guide 25,
  • Certified Lab Accreditation Assessor to ANSI/NCSL Z540-1
  • FCC and ANSI Accepted Assessor to ISO/IEC Guide 65,
  • Automotive Industry Accepted Assessor for Automotive EMC Laboratory Accreditation Program,
  • Certified Lead Auditor to ANSI/ASME NQA-1 and ANSI N45.2,
  • Members of the ASTM Committee E36 on Conformity Assessment
  • Members of the A2LA Accreditation Criteria Council, Accreditation Approval Committee, and Board of Directors Nominating Committee.
  • Members, past member or senior members of ASQ, ASME, IEEE, ISA, NCSL, ASTM, PDA, and various other groups relating to quality, software, testing, equipment assessments, or engineering.

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.

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