Deep Dive: Case Study – Quality Docs & QMS
Updated: Mar 31
Problem Statement: Organizations often struggle with effectively managing and tracking their quality processes and documentation, particularly when using legacy technologies. Quality processes, content, laboratory data, and training management applications are often spread across multiple systems, making it difficult to maintain accurate and up-to-date information.
Additionally, lengthy resolution times for integration issues and recurring quality events can cause frustration and decrease efficiency.
Organizations need solutions to streamline their quality management processes, including automated workflows, custom modules for tracking improvements, and integration with other systems.
Transformation towards modernizing Quality Management
Vault QMS & QualityDocs:
We have the expertise to support your organization to enhance both your QDocs and QMS processes in Veeva Vault.
QualityDocs: Implement Vault QualityDocs to track the different quality processes spread across different systems under a single roof and tracking of related documentation against different quality processes which accelerated and simplified the quality process tracking across the enterprise.
Implement Vault QualityDocs to track the different quality processes spread across different systems under a single roof and tracking of related documentation against different quality processes which accelerated and simplified the quality process tracking across the enterprise.
We help you ensure you have a well-defined Document Change Control process which is critical to ensure that your organization's content revisions are happening much smoother, and reduces the review & approval time,.
Also, having a periodic check will help you maintain your SOPs, Training and other important materials to be up to date.
QMS: It is important that your organization properly maintains all Quality Complaints, Deviations and Audits in a way it's easy to find and inspection ready. In addition to that, planning CAPA on time will ensure your quality standards are not compromised thus implement the vault-based Quality system QMS to manage the different quality processes such as Audits, Supplier Audits, and Inspections along with Quality Events (Findings, Deviations, Issues and Complaints) and their CAPA tracking.
Key Implementation by our Experts: (not limited to the below)
Document Change Control & Document Change Request: Enhanced DCC and DRC process and workflows.
Implementation of Periodic Reviews to ensure SOPs, Training and other important materials are maintained up to date.
Managing Facilities, Departments, sites, suppliers, contract manufacturers into continuous quality improvement processes.
CAPA: Implement enhanced CAPA workflows to address nonconformities identified during the internal audit.
Audits & Findings: Adopt audit management processes to help ensure that quality standards are being met and being improved.
Checklist: Implement and Enhance Checklist functionality to speed up Audit process from Planning to CAPA.
Implement Custom module to track Continuous Improvements.
Change Control Module implementation caters the tracking of Change for Regulatory Management activities.
Implement Risk module to manage and track risk-related processes such as Risk Registers, Risks and Mitigation Actions.
Configure Supplier Quality Assessment Module to track the supplier qualification and audits.
Formulate Integration with RIM Vault to handle Change Management Process.
Automated Workflow using Quality Teams in all modules.
Inbound & Outbound integrations built using middleware components such as SnapLogic, Globalscape, Mulesoft, etc.
Custom Archival solution implemented for all Quality Processes
Implement the Report Generation using Formatted Outputs using Merge Fields and Formatted output templates which will facilitate the data extraction from different object records in a structured and defined format
Benefits: Unified system to manage quality processes in different functions of the Pharmaceutical Organization which not only eases the user experience and increased efficiency in tracking Quality Metrics in different functions. Our IT experts have immense experience here with end-to-end implementation: developing, configuring, deploying and service operations.
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