In the life science industry, adjustments are a necessary element throughout the product lifecycle. From R&D through post-market, changes both big and small are inevitable in documents, requirements, and processes. For this reason, change management is embedded in Good Manufacturing Practices (GMP) as laid out in FDA regulations and ISO standards.
Many things can trigger a change. An updated product feature or a corrective action in a manufacturing process or a new regulation can all drive change. When considering modifications, you must have a clear understanding of their impact on product quality and safety. Change is so critical in regulated environments that it requires two aspects – change control and change management.
What are Change Management and Change Control?
In regulations and standards for medical device companies (FDA 21 CFR Part 820 and ISO 13485), change control refers to a formal review and approval of proposed changes affecting quality. It typically begins with a request for change, which must then be assessed. The quality team must create a plan to implement any change necessary and reject those that are not.
Likewise, FDA 21 CFR Part 211 for pharmaceutical companies has similar requirements in sections pertaining to control of components, processes, and packaging and labeling. In addition, ICH Q10 (Pharmaceutical Quality System) requires effective change control and change management.
After a proposed change is approved, it will proceed through the change management process, which refers to implementing the change and maintaining it. Change control is about individual change requests, while change management covers the oversight of all changes. Furthermore, change management includes assessing the implemented change to ensure its objectives were met.
It’s also important to note the difference between change and deviation. In the FDA and ISO environments, a change is planned and approved, while a deviation refers to an unplanned or uncontrolled change or event.
Common Change Management Pains
Everyone can agree that change management and change control are critical to any quality management system (QMS). The drawback is, there is no single way to practice it effectively. Regulations and standards specify what the requirements are but not how to achieve the required results.
Most people resist change. Call it the human element, but there’s a tendency to stick to the familiar. This is how you’ve always done it, why change now? This obstacle can hinder growth and innovation as well as cause noncompliance in a regulated setting. Unfortunately, resistance to change is the biggest reason why many life science companies continue to cling to paper-based processes, which in turn cause inefficiencies and other issues that lead to the following problems in structured change management and change control.
Lengthy change management lifecycle: Life science companies need to get products to market fast. The sooner they launch, the sooner they can realize ROI. However, inefficient change management and change control (and other quality processes) lead to delays in regulatory submissions and longer time to market. Here’s a breakdown of what typically causes a lengthy change lifecycle:
- Time-consuming processes: Once a change control request gets approval, a manual change management process entails routing a document (e.g., SOP, change order). This proceeds via email or through an in-person meeting involving stakeholders. Every step of implementation and post-implementation assessment will require more email exchanges and meetings.
- No mechanism for addressing bottlenecks: A manual process is prone to delays because it has no mechanism for escalation. Stakeholders who miss an email or a meeting or the absence of an approver can all potentially halt the process.
- Lack of transparency: Tracking the progress of a change implementation is harder when you have to dig through paper documents, examine spreadsheets and track emails. A manual change management process doesn’t give the quality team the big picture.
Lack of connectivity: Change management and change control are part of the quality system and do not exist in a vacuum. In a manual system, the change process is not logically connected to other processes. For example, a CAPA that triggers a change will require employee training or retraining, but lacks a formal transition point to initiate and manage training. If these processes can’t connect, you’ll risk noncompliance when tasks and issues fall through the cracks.
Poor collaboration: Manual change management and change control relies on stakeholder vigilance to make a collaboration work. It requires employees to stay on top of meetings, emails, documents, and tasks. The effectiveness of the process depends on meeting frequency and the availability of team members to meet. Without consistent awareness, the collaborative work necessary in change management will suffer.
5 Definitive Advantages of Using EQMS for Managing Change
The road to FDA approval and/or ISO certification is full of reiteration. Change that affects quality can bring a setback if you don’t handle it properly. How does your company manage change in processes and documents? How does your current quality system measure up to FDA and ISO requirements?
For companies that still use manual QMS or unconnected ERP, PLM, MES, and other applications, a shift in organizational mindset is necessary to address the human element. If there’s a resistance to automation, present the definitive advantages of an enterprise QMS (EQMS) to demonstrate how it can help align your compliance and business goals.
Here are the top advantages of switching from manual to an integrated EQMS within the context of change management and change control:
1: Increase control through automation.
A robust EQMS empowers your organization by providing the right tools for increasing control over tasks, processes, and documents. You will be able to define process ownership and user roles for increased accountability.
All tasks related to change management and change control will be automated, including routing, follow up, and approval. Time-based escalation will be automatic to speed up collaboration cycles in case some users are not available. Upon approval of a change, new versions automatically supersede the previous version.
2: Make change history transparent through FDA-compliant audit trails and electronic signatures.
Secure, time-stamped audit trail will make the history of every change visible to stakeholders, auditors, and regulators. The audit trail documents the identities of users who request, approve, and implement changes and when they occurred. Pick an EQMS with electronic signatures that adhere to the criteria set in 21 CFR Part 11.
A robust EQMS will also increase the transparency of the entire change management process with analytics and reporting tools. Supervisors will always be on top of things with dashboards that generate metrics on open change tasks. The capability to readily generate reports to pinpoint bottlenecks and other issues is one of the biggest advantages of EQMS over a manual system.
#3 Ensure compliance with the help of best-practice workflows and risk-based processes.
An effective EQMS leverages technology to address the human element. It provides best-practice workflows and risk-based processes. For example, a company performs a routine replacement of piston pumps used to fill sterile liquid in a biopharmaceutical product. Traditionally, the company doesn’t assess new piston pumps because they fall under the like-for-like replacement. As a result, no change request is submitted for this kind of event.
However, under a risk-based change management process, the EQMS requires such replacement undergo assessment and approval. While the piston pumps are the same brand and part number, it turns out that changes on the supplier side made them fractionally longer. The slight difference is enough to cause the pumps to touch the bottom of the filling blocks and generate metal particles, which will contaminate the batch. In this example, human element says the change is routine and doesn’t need an assessment. But the EQMS “knows” that the level of effort should be commensurate to the risk (product contamination) and compels an assessment as part of the process. Therefore, the EQMS helps avoid a quality issue.
#4 A closed-loop EQMS connects change management to CAPA, training, and other quality processes for a holistic approach to compliance.
A robust system doesn’t rely on vigilance alone for compliance; it connects all quality processes for a proactive posture. A CAPA or deviation will trigger change management and training seamlessly.
Keeping training current with procedures that have changed is a common problem, especially in a manual system. However, an EQMS will automatically connect processes with users and users with their tasks. If a CAPA that triggered change management requires new training, the EQMS will facilitate task completion with automatic notification and follow up. The system unites different processes and individual users into a holistic compliance effort so no task or issue falls through the cracks.
#5 A single source of truth helps ensure compliance.
Disparate systems can be effective on their own, so some companies don’t realize what they’re missing until quality issues emerge. For example, consider a device company with a CAD (computer aided design) system that does not integrate with change management.
Both systems are sufficient to operate independently. However, because they’re not connected, implementation of a design change entails manual input by engineers in the change management system. An unintentional error is made during input. The error doesn’t go through a change control process and change makes its way to the manufacturing floor, resulting in costly rework.
An EQMS that integrates the CAD design process with change management and other critical processes can solve the problem. It will eliminate the error-prone manual tasks required to bridge different systems. Ideally, you should have a closed-loop EQMS to serve as the single source of truth throughout your enterprise. It not only helps avoid quality issues but also fosters better communication and collaboration. A single platform can help remove siloes created by disparate systems. All stakeholders will go to only one place for every change-related and quality-related task they need to perform.
Change management and change control in GMP regulations and standards is meant to help regulated companies ensure product safety and quality. While every regulated company wants to comply with requirements, their good intentions are not enough to address factors such as the human element in change management. They need to leverage the right EQMS software to attain and maintain compliance despite the constant change in their operations.
Elements of a Modern and Efficient Change Management System
About the Author
Sal Lucido is Co-Founder and Executive Vice President AssurX. Sal is an unequivocal product evangelist and an expert in the area of quality process automation. He holds a broad array of responsibilities, ranging from overseeing strategic plans and operational improvements to managing tactical alliances.