Within the Quality Compliance arena, there are a number of Quality Management System (QMS) solutions that effectively complement each other in supporting organizations across the life sciences. Document Management and Change Management are two standard QMS solutions that are strong on their own, but they are even better together.

A Dynamic Duo in the Life Sciences

Life sciences companies can benefit from the cooperative relationship between the two processes, starting with document management. Improved visibility and management of documents is particularly beneficial for change management. Employees across an enterprise can tap into the same, current documents with up-to-date facts and figures, and with an automated document management system, they can do it quickly, boosting the organization’s agility in times of change.

When Document Management Takes the Lead

With a reliable and efficient document management system, individual departments and change management teams can better.

• Integrate siloed information and standardize operating procedures across the organization, thereby allowing everyone to pull from a single source of truth.
• Communicate any changes quickly throughout the entire organization.
• Increase product and process quality by ensuring employees have the right document at the right time.

By-products of these activities include improved decision-making and reduced possibility of errors, miscommunication, and regulatory actions through enforced compliance. In short, document management helps keep change in control.

When Change Management Takes the Lead

How does change management help keep the document management process in check? In the life sciences industry, it doesn’t matter whether change is driven by FDA, EMEA, or ISO regulations, or by competitive business forces – it’s undeniably critical to operations. It doesn’t matter whether the change being addressed in an internal change, or a process change that must be efficiently and accurately documented to ensure adherence going forward. It must be kept in control, and to do so, it commands that other inter-related processes, including document management, be reliable at all times.

To effectively manage change, an organization must be agile. Bottlenecks to operational agility might include an inability to locate data, or outdated SOPs that expose the company to noncompliance or financial, operational, or legal risk. These bottlenecks might rest within the document management process, rendering it unreliable. So, then what does change management do?

An effective change management system will take charge and guide document management by kick-starting document updates during the implementation of an approved change. This action:

• Provides a comprehensive workflow for documenting change from the initial change request through to the approvals and implementation.
• Reduces the risk of losing documents, or storing incomplete or unapproved documents.
• Increases the available transparency of what is being documented.

Document Management & Change Management are Better Together

On their own, these solutions are strong; together they are extremely agile, and they drive continuous improvement and overall organizational quality.

We’ve looked at their achievements as viewed from the user perspective. They are also high-achievers in the higher-level view from Quality Management leadership. The way leadership sees it, working in tandem, Document Management and Change Management solutions benefit Quality operations through:

• Accessibility: Organized, current, and visible documentation provides an easily accessible audit trail to keep the organization itself on track and to satisfy regulatory requirements at a moment’s notice.
• Collaboration: When electronic change requests integrate with electronic document management, they expedite the document update process and enhance project collaboration among impacted departments and functions.
• Security: Concise storage and accessibility of current documents, particularly SOPs, ensures that the right individuals are receiving the right documents at the right time. When change is in mid-stream, incomplete documents or those not applicable to certain departments cannot be accessed through a “back door.”

Life Sciences Enterprises Should Consider Recruiting the Two

Life sciences enterprises would do well to implement both Document Management and Change Management solutions, whether on their own or as part of an automated enterprise-wide Quality Management System (QMS).

An effective automated system will integrate document and change control procedures. It also will integrate with other solutions, providing access to approved, controlled documents in other areas of the quality system, including audits, CAPAs and employee training. In these cases, an automated system’s search and retrieval capabilities, dashboards, and repositories expedite the processes. The entire eco-system functions as one cohesive team.

An Integrated Solution to Drive Quality Compliance

Industry standards and regulatory guidelines recommend quality management processes which are integrated across the entire value chain. IQVIA meets those standards and guidelines with its quality management platform, SmartSolve®. Its modules, including Document Management and Change Management, share a common platform, and notifications, workflows, and data from separate processes are tightly linked. Activities and results in one module automatically inform and initiate actions in another, so you don’t have to.