The development, testing, implementation, and maintenance of computer systems and applications that support regulated processes must be governed by formal quality and compliance programs, and are expected to be inspected for compliance. The audit process of examining and verifying a company's fulfillment to certain regulations, guidelines, procedures, or policies, evaluates the adequacy and effectiveness of a company's quality system and determines the extent to which assigned responsibilities are actually carried out.
Life science organizations today face several auditing challenges. Internal auditing resources are limited and cannot handle the large number of IT projects and external suppliers that need to be audited and evaluated. Additionally, in-house resources may have limited expertise in important aspects of the business processes, application, and technology. They may only have narrow exposure to industry best practices across multiple companies. Another key challenge is avoiding a common tendency to rely too heavily on checklists that may actually not apply to every system or environment.
How AQS Can Help
AQS' quality audit services utilize expert audit teams that will extend your breadth and capabilities in conducting internal and external quality and compliance assessments, audits, and evaluations.
Our audit services leverage our expertise in regulatory requirements, quality systems, business processes in the drug and device life cycle, technology, applications, and a risk-based approach to compliance management. Audit recommendations take into consideration industry best practices, current regulatory expectations, and risk.
Computer System Validation Assessment – AQS examines a company's overall validation methodology, as well as adherence to its internal methodology and procedures and agency expectations.
Gap Analysis and Regulatory Reviews – AQS evaluates the level of compliance with regulatory requirements (GxP's and 21 CFR Part 11) and expectations, including the assessment of the company's quality program and compliance with their internal procedures.
System and Process Audits – AQS performs audits in order to identify and quantify vulnerabilities in a system or process.
Vendor Audits – Vendor audits are used to inspect and evaluate vendors' and external partners' quality programs, practices, and documentation. AQS can perform the audit for the client or participate in the audit as a lead or in a support role.
Mock Inspections – AQS performs a mock inspection, a process that simulates FDA inspections with role playing exercises. It includes sample SOPs and training to people who are potentially involved with an FDA inspection. It also provides information on how to respond to an FDA inspection.
Periodic Reviews – AQS can perform inspections at regular intervals or as triggered by a significant event such as a major change to the system, regulatory requirements, or the client's quality program.
Quality Reviews- AQS inspects project deliverables for quality and adherence to predefined requirements, strategy, and standards.