Audits and Assessments

Audits and Assessments FAQ

• What is a software vendor audit?

  A software vendor audit in the life sciences industry is an audit of the software companies’ products, services, and processes to ensure the technology aligns with their customer’s regulatory agency requirements. The audit typically reviews the vendor’s quality systems and software development process, including documented evidence such as procedures, tests, and records.

• Why audit suppliers and vendors?

  Life science companies are required to qualify critical vendors such as drug and component manufacturers and key suppliers. The list also includes software vendors who supply software solutions for critical processes within the drug and medical device manufacturing process. This qualification ensures that the vendors have consistent software and quality processes in place and that they are under a state of control that is satisfactory to the regulated demands of the life sciences industry. USDM’s Cloud Assurance service includes audits for the respective SaaS vendor (i.e. Salesforce, Box, DocuSign, Oracle, etc.).

• Why should I conduct a mock audit?

  Mock audits are usually performed well in advance of an actual agency or registrar audit. These “test” audits allow companies to self-identify any gaps in their processes and procedures that are audited by the FDA and other regulated agencies. Some of the types of mock audits include PAI (pre-approval inspection) audits, ISO audits, and cGMP audits.
  
  Here are the top 10 audit failures we see at life science companies.

• What is 21 CFR Part 11 and GxP auditing?

  Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations (CFR) that establishes the FDA regulations on electronic records and electronic signatures (ERES). Part 11 is a law that ensures that companies implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. The goal of the Part 11 audits is to ensure life sciences companies are implementing the required controls to ensure the safety of users of their products. GxP refers to “good working practices” about various areas of the life sciences industry. They include manufacturing, laboratory, clinical, etc. The audits are conducted against these practices to ensure compliance.

• How do I prepare for IT audits in medical device, biotech, and pharma companies?

  With 20 years of life sciences experience and former FDA auditors on staff, USDM is the leading consulting firm to help you prepare for audits in the biotech, medical device, and pharmaceutical industries. Our expertise delivers a proficient and efficient process to save you time and money. We provide single audit services, staffing augmentation to supplement your current audit team or managed services (i.e. Auditing-as-a-Service), where we offer a team of auditors to handle all your auditing needs.

  Read a case study on how we helped a customer get MDSAP-ready in 4 months.

• What is the FDA’s Pre-Approval Inspection (PAI) Program?

  A pre-approval inspection (PAI) is conducted to substantiate to the FDA that a manufacturing facility named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete. USDM conducts PAI-readiness audits and mock PAI audits to improve your probability of success.
   
  Read our white paper on FDA PAI.

• How can I be ready for a regulatory audit?

  There are many audit checklists online, but we highly recommend using a third party, like USDM, to get an unbiased, expert opinion on your audit readiness. This will help ensure that processes are documented and followed and that GxP records, objective evidence, and data integrity are adequate to pass the audit inspection. It also helps to identify any areas the require remediation if you are not audit-ready.

• How can I make audits more efficient, get the proper training, or get more prepared?

  USDM provides audit readiness training for anticipated and scheduled agency and registrar audits. Our team of experts can tailor a training program for your specific needs and help prepare you for an audit. These training sessions can be conducted both onsite and remotely.

• Drug Accountability Records & Drug Accountability in Clinical Trials

  Drug accountability is a serious issue. The FDA uses various categories in determining the seriousness of the deficiencies in clinical trials. Examples include clinical study documentation consistency, record completion, and process validation for the intended use.  We often see issues with negligent documentation or poor recordkeeping or lack of training that can be corrected and resolved with training and guidance. USDM can help with employee training and consistency to ensure drug accountability records don’t jeopardize your clinical study.
   
  Read a case study on how we helped our customer get MDSAP audit ready in 4 months

• Auditing the Quality of Medical Devices

  Medical device companies often have difficulties adhering to schedules for auditing and trusting the quality of their internal audits. USDM can help you stay on track and pass your audits and make it a natural flow of your business by conducting audits to ISO 13485 standards and general quality and regulatory compliance standards in the medical device industry.

• Planning, executing and making the most of internal audits in biotech, pharma, and medical device manufacturing

  Behind on your internal auditing requirements? USDM can manage your internal auditing schedule and ensure you are prepared. Often life sciences companies face a bandwidth issue that causes internal audits to be delayed or cancelled. USDM has conducted many internal audits for organizations facing such resource challenges. Our services are far more comprehensive than a checklist you might download online and offer flexible delivery options to meet your needs. Should we find issues, we can also help with remediation or assess the best steps to take from our findings. 

  USDM helped a customer address a Consent Decree and closeout a complaints backlog of 600k+ service orders