Vault QualityOne Processes
Finally, a pure-cloud solution has been built that brings together quality management and document control into a single application. Vault QualityOne simplifies the coordination, tracking, and conformance of the quality process through a consistent user experience. Vault QualityOne is a robust and flexible enterprise application that puts you in complete control.
KEY QUALITY PROCESSES
Vault QualityOne’s document management cloud solution enables tracking of documentation, specifications, and processes to ensure all users are using the correct and most up-to-date documentation. Efficient document control and document control processes are an essential part of compliance requirements for companies operating in GxP and ISO (e.g., 9001, 14000) environments, as well as in regulated industries.
Incident and Investigation Management
Vault QualityOne’s incident and investigation management solution enable organizations to more effectively manage quality or operational incidents. The ability to easily execute an investigation and root cause analysis ensures that companies are on top of their quality and compliance requirements. Incidents are defined as a departure from standard practices or specifications, resulting in non-conforming material or processes. These have the potential to impact product quality, safety, efficacy, or data integrity.
Vault QualityOne’s complaint management solution enables organizations to track complaints coming from their most valuable assets – customers. A robust complaint handling solution is at the core of any quality and compliance program. Effective complaint management reduces risk, increases customer satisfaction, and lessens the probability of product recalls.
Vault QualityOne’s CAPA management solution provides a comprehensive automated process for effectively managing corrective or preventive actions. Such actions originate with incidents, deviations, complaints, audits or other quality related events. The benefits achieved by using the Vault QualityOne’s CAPA solution include risk reduction, consistency in handling quality events, and the ability to measure the effectiveness of CAPA’s to reduce the likelihood of recurring events.
Vault QualityOne’s change control solution effectively manages all product and process changes by:
- Capturing change requests from across the business
- Engaging the right subject matter experts in impact assessment
- Following all review and approval pre and post change execution
- Tracking all implementation actions including seamless linkage to documents that require update
Vault QualityOne’s audit management solution tracks and manages the full continuum of internal and external auditing. Audits are an essential tool to reduce the risk of non-compliance with industry regulations and certifications. Vault QualityOne provides a best practice end-to-end audit management process, engaging all applicable audit parties, on-the-go and wherever they may be. Key aspects of the Vault QualityOne audit management solution includes:
- Audit scheduling and planning
- Storage of all pertinent artifacts used in support of the audit process (e.g., documents, pictures, videos).
- Issuance of findings and subsequent management of corrective actions.
- Linkage of audit findings and CAPA plans
- Ability for external entities to respond directly to audit findings (e.g., suppliers).
Supplier Quality Management
Vault QualityOne supplier quality management (SQM) solution can transform your supplier relationships to closer partnerships dedicated to improving quality, ensuring ongoing compliance, and reducing risk. Vault QualityOne facilitates this shift by enabling all parties, internal or external, to work together through supplier certifications, audits, and performance monitoring on the same validated cloud solution. By accessing the same data, teams and their partners can improve collaboration and speed, increase transparency and accountability, and minimize manual or redundant efforts.
Vault QualityOne training management solution allows employees to complete training and maintain training records in accordance with internal company procedures, corporate policies and external regulations. Training Management ensures that employees are always up to date with the training requirements for the role they perform, which ultimately supports company compliance with regulations and certifications. The Vault QualityOne Training Management solution can also be extended to include external stakeholders that are part of your business processes.
Standards & Regulatory Workbench
Vault QualityOne’s standards & regulatory workbench provides a resource center that allows companies of any size, across any industry to extend, customize and control their end-to-end quality process to ensure adherence to ISO, GxP and other regulatory specific requirements. From process to discrete manufacturing to regulated services, or a combination of them all, Vault QualityOne can support standards across your business units as well as autonomous needs that are only specific to one group. This is achieved through Vault QualityOne’s native standard and regulatory features such as comprehensive audit trails, flexible workflows with optional 21 CFR Part 11 electronic signature, and tight security controls on documents and processes. The flexibility of the Vault platform allows for organizations to focus on their specific processes and use technology to enable and enforce them.
Vault QualityOne Document Control
Vault QualityOne Incident and Investigation Management
Vault QualityOne Complaint Management
Vault QualityOne CAPA Management
Vault QualityOne Change Control
Vault QualityOne Audit Management
Vault QualityOne Supplier Quality Management
Vault QualityOne Training Management