One of the key components for Life Sciences companies is to have their documents and data in order. Document management began its rise in the 1980s when software developers started blending traditional paper-based documents with digital technology. A document management system (DMS) serves as a central location for all documents, providing storage, metadata, security, retrieval and indexing.

Most Life Sciences companies have adopted two types of electronic solutions—quality management systems (QMS) and DMSs. Both systems play an important role, but they can create new barriers to quality if they operate independently.

The highest functioning quality programs integrate their quality management and document control processes. In doing so, they maximize the effectiveness of both solutions, provide greater transparency and create stronger collaboration around quality. 

Mitigating Quality Management Complexities  

To effectively manage quality, leaders must track and control an intricate web of quality events, any one of which could trigger numerous parallel or downstream actions. Digital QMS tools are more effective at managing quality activities, enabling faster business processes by enforcing and automating workflows, faster critical processes and meeting regulatory compliance with record retention.

An increasing number of Life Sciences companies are now leveraging advanced capabilities, like machine learning and natural language processing, so quality events and complaints can be processed accurately. 

A Better Approach to Document Management  

Governing bodies have strict standards on how quality measures are both performed and documented. As a result, document management is just as complex as managing quality. A DMS needs to allow for the complexity Life Sciences companies must adhere to and yet be user-friendly. To manage the complexity, Life Sciences companies need a document management strategy that can address a standard and repeatable protocol for creating and revising documents, roles, ownership and access to documents in varying stages. They also need a solution that will provide security throughout a document’s lifecycle and enable them to prevent or recall rogue or outdated documents.

The Power of Integration  

Integrating quality management and document management offers numerous benefits, including improved processes and efficiency, helping to meet compliance with regulations, increased customer satisfaction and enhanced collaboration.  

This holistic approach ensures that organizations are better equipped to respond to changing market conditions and make informed decisions. 

Bridging the Gap between Quality and Document Management 

Life sciences companies require digital tools that can match the complexity and scale of their quality management operations. Modern solutions are flexible enough to meet various quality and documentation requirements, enabling efficient and effective execution. By integrating quality tools such as QMS and DMS, these systems can enhance each other, improving performance, meeting compliance, providing better visibility and minimizing risks.