Even small changes in the supply chain can initiate a lengthy set of actions that affect related processes, procedures, and documentation. Otherwise, organizations can’t effectively measure or improve quality across the enterprise.
There are commonly two types of solutions life science organization use to manage this process effectively—quality management systems to track processes and controls, and document management systems (DMS) to store and track all documentation related to quality.
Both of these systems play an important role in quality management. However, to truly be effective they can’t operate independently. Siloed systems cause gaps or lags which degrade the solutions’ benefits, including enterprise visibility, speed and automation.
Let’s consider why effective quality programs integrate quality management and document control processes to maximize the effectiveness of both solutions, increase visibility and create stronger collaboration.
Alleviating the Challenges to Manual Document Management
Governing bodies have strict standards on how quality measures are performed and documented, which adds to the complexity of document management. For example, the FDA specifies how documents should be signed, displayed and stored. Every technical process that is updated has associated documentation that will also need to be changed, resulting in an influx of paperwork that must be updated, reviewed and approved. Manually managing this process can prove overwhelming and leaves room for human error.
To manage this complexity and ensure compliance, life science organizations need a document management strategy that provides:
- A standard and repeatable process for creating and revising documents
- Roles, ownership and access to documents in various stages
- Security throughout the document lifecycle
Digital DMSs enable organizations to have tighter security and control over documents that are managed digitally, by requiring a login and password so administrators can limit access to users with the appropriate level of authority. These digital solutions track every document action, providing visibility into who made changes and when.
An electronic activity log also promotes accountability, mitigates the risk of lost documents and using outdated versions. Leveraging a cloud-based solution further extends these benefits. Stakeholders can access, update, review and approve documents from nearly any location, and collaborate in real time.
The Benefits of Digital Quality
To effectively manage quality, organizations must track and control a multitude of quality events, any one of which could trigger numerous parallel or downstream actions. Any deviation from a company’s quality standards must be tracked, investigated and corrected quickly and effectively.
On top of this, quality management impacts every area of the business. Finding and tracking all the potential impacts to quality is complex and challenging. Yet identifying sources of quality is just one step. Life sciences companies must also track and manage every change, implementation and resolution.
Given the complexity and scale of modern operations, digital tools are more effective at managing quality activities, and enable organizations to:
- Reduce the time and risks associated with manual reporting
- Provide consistent change control processes
- Speed up critical processes for greater efficiency
- Improve corrective and preventive action (CAPA) management
- Provide auditable assurance that regulatory requirements are met
- Ensure visibility into quality across the organization
Using digital tools, life sciences companies can also leverage advanced capabilities, like machine learning and natural language processing, so quality events and complaints can be processed faster and more accurately. Reporting tools can be configured to match the unique preferences and needs of different users and roles.
Integrated Tools Create Value
Life sciences companies need digital tools to match the complexity and scale of their quality management operations. Modern solutions are adaptable to meet quality and documentation requirements—and can execute them with maximum efficiency and effectiveness.
Integrating your quality and document management systems adds value to each solution, ultimately improving performance, ensuring compliance and visibility, and minimizing risk.
Looking for more information on the benefits of integrating your QMS and DMS? Get deeper insights in this white paper.