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Compliance Auditing Services

Auditing Services
Azzur Consulting provides quality & compliance auditing services to clients who are seeking a compliance assessment in areas including but not limited to internal and external (supplier/supply chain) quality, software development life cycle processes, clinical laboratory operations (CLIA), IT data center operations and governance. Our certified audit personnel seek to assess and understand your organization's risks, and review your (or your supplier's) internal SOPs, software development procedures, and documented evidence of adherence, in order to assess the overall level of compliance. Our audit processes are informed by the most current industry standards (for example, PDA, GAMP5, CISA) and are fully customizable to target your organizational needs. For example, an audit team may be comprised of representatives from both the customer oversight group and Azzur IT Subject Matter Experts.

The audits review documentation and focus on:
  • Accuracy/reliability
  • State of Control
  • Clarity/Comprehensiveness
  • Completeness/Appropriateness

An audit team will be established with representatives from both the client and Azzur Consulting.
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21 CFR Part 11 Compliance

Azzur Consulting has active Part 11 participation with PDA, ISPE, GAMP, IVT and ASQ. Our project portfolio includes over 350 Part 11 projects. As Part 11 guidelines continue to develop Azzur Consulting is your solution to advise and contribute regulatory solutions on Part 11, CAPA, and Risk Based Approaches to compliance through participation in committees, tasks groups, conferences, and published papers.
 

PDMA

Azzur Consulting provides auditing services that are truly independent. We don’t provide reconciliation services and we don’t have a sample fulfillment warehouse, thus allowing us to be free from conflict of interest questions.

We can provide you with supplier audits of your sampling program service providers. We are able to provide an in-depth review of your supplier's process as well as compliance with applicable regulations such as 21 CFR Part 11.

We can provide you with field operations audits to verify that your sales staff is maintaining appropriate documentation and storage of product samples.
 

Supply Chain Management Systems Compliance

Today’s global market demands that companies operate more efficiently than ever. Instead of discrete applications that do not communicate outside their own environment, companies are implementing global business solutions that address the needs of the enterprise. Azzur Consulting understands the business needs of the corporate environment, and merges their business systems savvy with their regulatory compliance experience to provide solutions to the FDA regulated industry. Our experience includes the leading ERP/MRP, Content Management and Supply Chain applications, as well as Document Management (EDMS), Corporate Quality, and CAPA Systems. Whether you need proven Project Managers to affect a compliant business solution, or need a Validation Master Plan for all of the shared applications, Azzur Consulting can address your compliance concerns.