Audits are a routine element of quality management. However, very few of these audits are done correctly with a full independent evaluation. QACV Consulting will provide a complete and independent audit and truly evaluate your organization without any conflicts of interest. Our independence helps identify findings early on before they become a serious issue. We offer key quality aspects below to ensure your audit is successful right from the start.
- Customized Audits: QACV will evaluate your company and work with your organization to perform the type of audit you want. We take the time to listen to your needs and truly understand our role in the audit process.
- Experienced Auditors: Our lead auditors have performed numerous audits and have at least 10 years of in-depth working knowledge of the regulated environment. In addition to these qualities, QACV auditors are great project managers that will provide your audit report in a timely and flawless manner. This expertise and service is provided at no additional cost to you. It’s just how we work. The best people are on the job for you and work tirelessly to provide your organization with the results you need, when you want them.
Quality Audit Services Include:
- Data Integrity Assessments: QACV has extensive experience in conducting data integrity assessments for both paper and electronic systems and processes. With regulatory agencies all over the world focusing on data integrity, identifying and remediating your data integrity gaps in this important area is critical to maintain compliance. Focusing on both data integrity governance programs as well as detailed assessments of data integrity systems and processes, QACV can help you meet your compliance objectives.
- GLP Audits: Our Good Laboratory Practice (GLP) Audits can evaluate your company’s facilities, studies or reports and assess for GLP compliance. Our expertise doesn’t end there. If a finding is made, we can provide full staff training to ensure that your organization will transition into full compliance standards easily and effectively. You don’t have to go it alone.
- GCP Audits: Good Clinical Practice (GCP) Audits are essential to ensure that the rights of trial subjects are respected according to the Declaration of Helsinki. In addition, the integrity of trial data must be assured throughout all stages of the trial. Quality management systems and internal Standard Operating Procedures (SOPs) need to meet regulatory standards. QACV can provide GCP audits at any phase of development and work with you to improve the overall quality of your systems and procedures. Conducting a GCP audit can be a very challenging process due to the location of investigator sites and sponsor organizations. Our quality auditors are knowledgeable in the global setting and are equipped to adapt to these growing complexities.
- GMP Audits: Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect almost everyone. Consumers have high expectations for quality standards regarding medicines and rely on manufacturers to produce safe and effective products. Demonstrating Good Manufacturing Practice (GMP) is vital to securing customer trust, strengthening your reputation and will ultimately grow your business. A GMP audit from QACV Consulting will help you exceed industry standards by evaluating your internal processes as well as supply chain to manage and improve quality. Our global standards of quality will help your organization establish strong quality management systems, obtain appropriate quality raw materials, establish robust operating procedures, detect quality deviations and maintain reliable testing laboratories.
- Supplier Audits: QACV Consulting can provide an evaluation of suppliers’ quality system and compliance with Good Manufacturing Practices (GMP), IPEC-PQG Guideline, and Good Distribution Practices (GDP). A full review of chemistry, manufacturing, and controls (CMC) as well as laboratory testing and post-verification surveillance testing and auditing can be provided as well.
- Computer System Validation Audits: Whether your software is custom or off-the-shelf QACV Consulting can provide a complete Computer System Validation (CSV) audit at any stage of the life cycle of a computerized system. Your CSV audit can be a full comprehensive evaluation, or a focus on a particular function, operation or system. We can verify compliance with 21 CFR Part 11, Annex 11, Good Automated manufacturing Practice (GAMP), ICH guidances and other FDA regulations. Our CSV audit staff will assess your documentation including SOPs, training methods and corrective and preventative procedures to identify any gaps in your quality system.
- QACV Consulting provides a variety of CSV audits that can be integrated with other GxP compliance audits including:
- Software Vendor Audits or Prequalification Audits
- For-Cause Audits and
- Hosted Services Audits