service-auditingJAF Consulting provides expert Quality Assurance and Regulatory consulting services to pharmaceutical, biotechnology, medical device, and dietary supplement industries to help ensure they comply with current business practices and current regulatory interpretation. Our team of auditors can perform a detailed assessment of your existing quality systems and processes, to highlight problem areas and recommend improvements, so that you can build quality systems that are appropriate for your company’s stage of development. We can assist you with all aspects of compliance, as they impact your products, including GLP, GMP, QSR, and GCP.

Our QA team also offers a comprehensive range of auditing services for laboratories to meet global GLP and GMP requirements. We also offer expert advice and guidance in laboratory quality issues, assist with the establishment of quality management systems, the preparation of laboratory policies and SOPs, and the planning of routine monitoring and QC procedures. In addition, we can conduct GMP audits of process development and formulation laboratories, as well as manufacturing and packaging facilities. We can also conduct similar activities on your behalf for third-party contractors.

Let JAF help you prepare and execute a structured Compliance Audit Program that will demonstrate regulatory compliance of your computerized systems and supporting practices. JAF works as a partner with clients who are in need of Audit services in order to provide them with rapid unbiased solution to a particular product or organization. JAF provides high quality Audit Services that embody a practical and cost effective approach in assisting clients comply with today’s regulatory requirements.

GxP Auditing Services

GxP System Audits

We can perform a detailed assessment of your quality systems to assist you in preparing for Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Quality System Regulations (QSR) inspections by Regulatory Authorities, clients and corporate partners. Our experience covers biotechnology (including cell and tissue-based therapeutics), pharmaceutical and medical device companies. Our team conducts compliance audits of your third-party contractors and vendors and will assist you in preparing for regulatory authority inspections, including FDA pre-approval inspections of manufacturing facilities.

Computer System Validation Audits

JAF provides a comprehensive Computer Systems Validation (CSV) audit services in all stages of the computerized system life cycle. The objective of the CSV audit is to assess good systems implementation practices as well as good IT system management practices, and to verify that the computerized system is validated according to predicate rule regulatory requirements as well as 21 CFR Part 11. JAF Consulting provides a pragmatic approach to CSV Auditing, which provides many benefits to the auditee, such as reduced cost of maintaining the computerized system and a reduced risk of system non-compliance. A CSV audit involves:

  • A review of all procedures and operational documentation
  • A review of all software development documentation
  • A review of all validation deliverables (Plans, Protocols, Test cases and Results)
  • Assessment of computer room operations and hardware
  • A review of network design and configuration management

Clinical Trial Audits

In addition to system audits, our team conducts study-specific GCP audits of protocols, investigator sites, master files, pharmacovigilance, databases and reports for a wide variety of clinical studies. With our expertise you can be sure that quality is maintained at every stage of your clinical trial. We also are specialized in electronic systems audits.

The audits will be tailored to your particular compliance needs and relevant for the stage of product development. Our QA team have performed audits in the US, Canada, Europe, Asia, and Pacific Rim.

Laboratory Audits

When using laboratories, whether research (non-GLP), pre-clinical (GLP), clinical (GCLP) or commercial product QC support (GMP) laboratories, you need to be sure that the data is credible and complies with protocols, SOPs and regulatory requirements.

Our QA personnel provide a comprehensive range of auditing services for all types of laboratories. We offer expert advice and guidance in laboratory quality issues, assisting with the establishment of quality management systems, the preparation of laboratory policies and SOPs, and the planning of routine monitoring and Quality Control analytical test procedures.

Manufacturing Audits

Our professionals bring their direct experience in small molecule, biologic, drug substance, and dietary supplement manufacturing to help you with your QA needs at every stage of product development. We can coordinate the quality aspects of projects ranging from process improvements to “greenfield” construction including facility design, construction and commissioning using direct staff and preferred subcontractors with the facility and equipment validation experience needed to make projects of any size a success.

Our team coordinates the conduct of GMP audits of process development and formulation laboratories, as well as manufacturing, distribution and packaging facilities.

Vendor / System Selection Audits (RFP & RFQ)

Information Technology Auditing Services

Software as a Service (SaaS) Audits

Sarbanes Oxley – Section 404-409 Audits

IT Infrastructure and Software Development Audits

Healthcare and Insurance Auditing Services

Physician Compliance Audits

Healthcare Insurance Claims Audits

JAF provides comprehensive retrospective and prospective review of all employee and dependent claims and financial data utilizing audit methodology unique to our organization. The results of the audit will allow premium billing reductions and / or claims payment credits or cash returns, which will enable you to more accurately budget and afford your medical programs in future years. Our fees are based on a contingency arrangement and are payable by you only when you realize confirmed billing reductions, credits and/or cash returns from the insurer and / or medical plan administrator.

HIPAA Compliance Audits

While the HIPAA audit delay announcements may cause a sigh of relief among some covered entities and business associates, now is the time to prepare. OCR will conduct more on-site audits and fewer desk audits than previously planned, the audits are part of OCR’s enforcement arsenal and the outcomes could lead to sanctions and monetary fines. Alston & Bird stands ready to assist with reviewing and updating HIPAA policies and procedures; enhancing HIPAA compliance; responding to OCR during a HIPAA audit, compliance review or investigation; and interacting with OCR regarding audit, corrective action and/or enforcement efforts. Please let us know how we can help you get ready.

Additionally, we assist clients in:

  • Completing post-audit follow-up actions
  • SOP writing and system implementation services
  • Preparing and reviewing third-party quality agreements for contract manufacturers