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Audit Management Software

Reduce time and effort needed to successfully pass audits by automating audit-related activities.

Enhance your audit-related activities with automation

SimplerQMS audit management software system allows for automated data collection, routing, notifications, follow-ups, approvals, and escalation of activities.

Every time an audit finding occurs, our audit software system allows you to easily link a response such as a nonconformance, supplier corrective action request (SCAR), or CAPA.

Automated workflows ensure that the relevant persons are notified when they are assigned a specific task. You can easily track everyone’s performance towards their due dates through customizable Dashboards and Notifications, allowing you to get an overview of the documentation status.

Ensure better audit preparedness

With SimplerQMS, you won’t have to spend days worrying in preparation for an audit.

Use built-in dashboards to gain a centralized overview of all the documents needed for an audit.

SimplerQMS integrated, cloud-based, audit software collects documents and reports across the product life cycle, in a single location. This allows you to access needed documentation and present it to the auditor with a couple of clicks from anywhere. Easily share the relevant documents with external parties like notified bodies or internal auditors.

Recommended reading: Remote Auditing Best Practices

Ensure regulatory compliance

SimplerQMS audit management software system helps to comply with standards of various internal and external audits in the Life Science industry.

For example, GxP, cGMP, ISO 13485:2016, EU MDR, EU IVDR, FDA 21 CFR Part 11 compliant electronic signatures, time-stamped audit trails, and reporting capabilities.

Simplify your audit process

With SimplerQMS, you can manage tasks, plans, notifications, follow-ups, and any actions resulting from audit findings or in preparation for an upcoming audit.

Easily bundle all the upcoming audits under an Audit Plan. Streamline planned audit activities by scheduling activities, setting due dates, and sending out automatic notifications to the right personnel. Quickly escalate high-risk findings for further investigations and corrective actions. Track low-risk findings for reoccurrence. Produce and share final audit summaries with ease.

Streamline supplier audit-related activities

With SimplerQMS, you can assign specific suppliers to follow-up actions and hyperlink to deviations, nonconformance, and complaints. This allows you to see whether there were issues with the supplier in the past.

Regardless if you had or hand not conducted supplier audits before, with SimplerQMS audit management software you can do it more effectively.

Connect all your quality management processes

With SimplerQMS audit software you can easily link audit findings to other Quality Management system processes such as products, components, customers, suppliers, and equipment.

Upload and hyperlink any document, record, file, and email to audits, as evidence. One centralized location, cloud storage, and automated workflows ensure that your documentation is always complete and more accurate.

Looking for more modules?

Regardless of the stage of your Life Science organization, our integrated software modules cover all your needs.

Training Management Module Icon

Training Management

Save time with automated training activities, learning overview, reminders, and generation of training certificates.

CAPA Management Icon

CAPA Management

Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.

Complaint Management Module Icon

Complaint Management

Reduce the associated risks and resolve issues quickly by optimizing complaint management processes.

Change Management Module Icon

Change Management

Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.

Design Control Module Module Icon

Design Control

Manage all the necessary processes related to product design and meet design control requirements with ease.

Document Management Module Icon

Document Control

Automate and standardize your document control activities with ease.

Equipment Calibration Icon

Equipment Calibration

Manage your equipment calibration schedule and automatically assigns tasks before due dates.

Electronic Signature Module Icon

Electronic Signatures

Sign and send the necessary documents for authoring, review, approval, from anywhere in the world, at any time.

Product Lifecycle Management Icon

Product Lifecycle

Plan and organize all your product management activities and integrate them with other processes.

Deviation Management Icon

Issue Management

Simplify your issue management workflows by automating tedious tasks.

Risk Management Icon

Risk Management

Consolidate risk and handle your risk management file in a well-organized and structured manner.

Supplier Management Module Icon

Supplier Management

Simplify supplier-related activities and handle your supplier documentation following the standards.

Form Management Icon

Form Management

Standardize your documentation processes and boost employee productivity with effective document forms.

Deviation Management Icon

Deviation Management

Streamline the investigation, documentation, and resolution of all your deviations.

Electronic Batch Records Icon

Electronic Batch Records

Digitize and automate your batch record processes to ensure regulatory compliance.

Nonconformance Management Icon

Nonconformance Management

Identify, evaluate, analyze and manage nonconformances more efficiently.

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Ready to learn more?

To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.

SimplerQMS Demo Interface