AODocs QMS: Packages and Features

Features

Document Control
Enforce strict document management procedures that you control. This covers granular permissions, document sharing, and approval. Examples of documents controlled within our solution are Standard Operating Procedures (SOPs), policies, procedures, work instructions, and more.

Change Request
Manage changes to documents performed by designated individuals as part of workflows with eSignature.

Quality Records
Create QMS documents and prevent editing once they become final or at any point in the process depending on the use case (doesn't include classification and retention).

Review and Acknowledgement
Record acknowledgment that training documents have been reviewed with eSignature.

Business Dashboard
Use pre-built QMS operational metrics from day one. Our Business Dashboard provides Documents by Workflow State, Documents in the System, Records by Workflow State, Phase time, Change Requests by Workflow State, and Workflows by State which can be filtered date, department, and location.

eSignature via third parties
(including regulatory compliant 2-factor authentication for document approvals)
Ensure only authenticated users can sign-off on process closures and record the date- and time-stamped signature. Includes out-of-the-box integration with Okta and Duo (subject to purchasing applicable third party tools).

Human-Readable Audit Log
Capture all user actions taken in AODocs libraries as an immutable record in a human-readable way to evidence full traceability.

Validation as a Service
(for Life Sciences customers only)
Validation is a regulatory requirement that establishes documentary evidence demonstrating that a procedure, process, or activity of the company was adequately tested. Qualification is the part of validation which demonstrates that the process or software used by the company meets all specifications and that all required components and documentation needed for continued operation are installed and in place. Qualification ensures that the software is working as intended. Each new release is validated in days because it is fully automated. Some examples of reports produced as part of qualification and validation are Validation Plans, Functional Requirements, Traceability Matrices, Protocol Execution Reports, Validation Summary Reports, etc.

PDF Renditions
Create PDF files containing selected attachments from AODocs documents. The PDF is created when the document becomes effective. Each version of the document has its own PDF.

Dossier cover page
Populate AODocs document attachments from metadata to create a cover page and/or headers and footers.

Corrective and Preventive Actions (CAPA)
Identify, address, and prevent regulatory, organizational and manufacturing non-conformance. The CAPA module provides a written record of investigation of non-conformance, including conclusions and follow-up actions.

Audit Management
Manage and view all audit related documentation in one place.

Quality Events
Document, track, and monitor consumer complaints, recalls, and other incidents triggering quality improvements, using workflows.

Testing and Acknowledgement
In conjunction with our Review and Acknowledgement module, the Testing and Acknowledgement module adds further comprehension of a controlled document and creates a record of knowledge test completion.

Design Control Management
Manage product design and development files to help meet regulatory requirements.

Equipment Asset Management
Manage, monitor and track the appropriate information required to adequately manage equipment assets such as serial numbers, scheduled maintenance dates, maintenance cycles, history of service requests, etc., to evidence that the equipment is suitable for the intended purpose and capable of producing valid results.

Supplier Management
Document supplier audits; monitor, document, and review supplier performance; and establish appropriate written quality agreements regarding responsibilities for activities.

Business Intelligence and Reporting Dashboard
In addition to our standard Business Dashboard, we provide powerful customer-specific business intelligence dashboards and reporting visual analytics to identify bottlenecks in QMS workflows and approvals, monitor QMS performance, maintain complete QMS process oversight and understand the adoption and ROI of QMS across your company. The strategic dashboard includes metrics such as performance over time, number of open CAPAs, time for CAPAs to close, effectiveness of actions taken, ROI, non-conformances, number of help tickets, etc. The analytical dashboard includes metrics such as trends or deeper insights, quality control costs, customer satisfaction, number of issues per project, scope creep, downtime, etc.

Advanced Roles
Implement a flexible approval process including delegated/proxy approvers, approval matrix, and tiered employee groups.

Integrations
Integrate your QMS with related systems, like Learning Management Systems (LMS) such as Cornerstone, Product Lifecycle Systems (PLM) such as Jira, and Case Management Solutions such as Salesforce, to maintain a holistic view of the quality program.

Roadmap features (coming soon)

Customer Complaints
Input customer complaints and subsequent tracking of changes in documentation, processes or outcomes as a result of complaints and feedback from customers. Provide integration with external solutions and management of related CAPA actions for complaints.

Non-conformance Management
Implement a tracking mechanism for non-conformity management along with events that capture non-conformity.

Record Retention and Legal Holds
Capture, retain, manage, and delete documents in AODocs libraries based on retention policies to meet regulatory and legal requirements. Manage legal holds and support manual and automated disposition review/approval process.

Risk Management
Create and manage risk-related records and activities.