Azzur Group, and our cGMP-qualified consultants, provides quality and compliance auditing services to clients who are seeking a compliance assessment in areas including internal and external (supplier/supply chain) quality, software development life cycle processes, clinical laboratory operations (CLIA), IT data center operations, and governance. The goal of a quality and compliance audit is to review whether the business is operating in conformity with the established policies, guidelines, codes, and procedures. Our certified subject-matter-experts 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.
Azzur's experienced subject matter experts team up with representatives from our client's business to create a comprehensive audit team with hands-on participation. Our team of auditors work closely to ensure the relevance of the complete evaluation and provides clear documentation.
Azzur's quality and compliance auditing services include:
21 CFR Part 11 Compliance
Azzur has active Part 11 participation with PDA, ISPE, GAMP, IVT and ASQ and our project portfolio includes over 350 Part 11 projects. We advise and contribute regulatory solutions on Part 11, CAPA, and Risk-Based Approaches to compliance through participation in committees, tasks groups, conferences, and published paper, as Part 11 guidelines continue to develop.
Azzur provides autonomous auditing services. We don't provide reconciliation services and we don't have a sample fulfillment warehouse. This conscious commitment allows us to be free from conflict of interest questions.
We 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 even 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 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 put a compliant business solution into effect or need a Validation Master Plan for all of the shared applications, our subject matter experts can address your compliance concerns.