Audit Management

Audit Defense Readiness

Discover and resolve issues by building a continuously improving Quality Management System (QMS) by digitally transforming your audit management process – right from audit planning and preparation to audit report and closure

Make it easy for people to drive efficiency and effectiveness into the audit management process

With CQ’s Audit Management Software, we ensure companies have the ability to build a flexible, scalable and configurable audit management workflow. Depending on the specific needs of your organization, you can automate a rapid audit process or configure a workflow for a complex audit.

Create, schedule and manage your audit program using the calendar view available in the CQ Audit Management Software. The software also facilitates collaboration between stakeholders during different stages of an audit and helps the enterprise build a QMS workflow that is data-driven and enables Continuous Improvement (CI). CQ’s Audit Checklist feature helps quality leaders “know their gaps”, take preventive action and, overall, stay compliant to all regulations.

Enable promptness and perfection in audit performance

Businesses need to plan their internal and external audits and determine the frequency based on the business risk and relevant regulatory requirements. From audit planning, scheduling to documenting findings and initiating CAPAs where required, CQ Audit Management Software automates the entire audit workflow. Quality leaders can set up calendar views that enable all stakeholders to be alerted about scheduled audits and prepare accordingly. It also empowers them to flexibly choose between complex, stringent or streamlined audits.

Ensures effectiveness and continuous Improvement of your QMS

Automating the audit workflow with CQ Audit Management Software empowers business and quality leaders with data at their fingertips – to identify gaps and predict quality performance in the future. The software gives access to documents and reports of past audits as well to enable you to capture failure trends and take corrective and preventive action for continuous improvement. With this, businesses can experience better performance, customer satisfaction, and thereby, growth in revenues.

Stay Compliant

Different regulatory standards such as ISO 9001, ISO 13485, FDA 21 CFR Part 11 have different requirements. The regulations cover all aspects of the product value chain and the need for each function will vary depending on risk factors. With CQ Audit Management Software, planning audits around each of these and defining the frequency based on the gaps and business risks becomes easier and can improve compliance.

Always remain audit and inspection ready

The key to being 100% compliant revolves around having a proactive risk management strategy. The first step to risk management is to know your gaps. And, the audit process helps you uncover and document these gaps. To remain audit and inspection ready requires the business to plan, manage changes, learn from the past audits, create schedules and assign roles and responsibilities, organize data and documents and conduct periodic internal audits. The CQ Audit Management Software helps in every step of the way, providing visibility and transparency across the entire process.

Avoid fines and penalties

Warning letters, product recalls and fines are some of the ways non-
compliance is penalized. This can cause losses in terms of investments for reworking a product or scrapping it and starting afresh. Litigation, penalties and compensations can add to the costs. The reputation of the business can also suffer causing a severe dent in market growth. Periodic and well-planned and executed audits can help mitigate these risks by identifying the gaps in a timely manner and reduce the impact to the business. The CQ Audit Management Software can manage the entire audit cycle to ensure greater compliance and growth.

Support Your Entire Organization

Audit Leader

Enable audit scheduling for auditing the supply chain, internal operations, and regulatory compliance

Audit Coordinator

Scheduling audits at a predefined frequency for key suppliers, R&D, manufacturing, testing

Auditors

Complete the full audit process, access past audit data, have greater document control

Operations/Supply Chain

Ensure processes are being followed

Management

Review and analyze the effectiveness of the audit program and the state of compliance

“As a Life Sciences manufacturing services company, our company decided early on that a flexible, agile QMS was a must. We had a very clear set of requirements: cloud-based, cross-platform, mobile-enabled, paperless and e-signature capable. After reviewing available solutions against these, only ComplianceQuest met our needs.
Right after the demo, we knew we had a winner. The implementation process was relatively smooth and our solution engineer was top notch. We went live very quickly and recently aced our first customer external audit.”

–CEO of a fast-growing life sciences manufacturing services company