Change Control Software

In the ever-advancing world of life sciences, the only constant is change. Change is necessary for growth and progress in the industry. However, changes also come with challenges. Massive overhauls can be messy and difficult to adapt to, often resulting in lost data or processes.

Change control software is a solution to most life science organizations' change control problems. These are specially designed to meet the needs of life science companies and make both major and minor changes go smoothly.

What is change control software in the life sciences?

Change control is a commonly used process in life sciences that controls and records any planned changes applied to a product development process or system to ensure the safety and efficacy of the process and product.

Change control is used to keep operations running smoothly during intended changes, track those changes, ensure compliance through proper authorization, and monitor the outcomes. Thus, the entire process requires a lot of data, which makes it quite time-consuming.

Change control software is used to manage the change control process more effectively and efficiently. A well-designed software like Scilife’s change control management software can track changes, keep a record of all proceedings, track results, and ensure task completion by following change requests. It ensures a streamlined process and airtight regulatory compliance. 

Common features of change control software

Several types of change control software are available with varying services. Ideal change control software comes with several features to manage change requests, track workflows and updates, ensure quality, etc.

Here are some features and how they work.

Change request management

Most software has a system where changes can be initiated and sent to appropriate groups. From there, the creator can track and manage change requests. Most software allows group members to update, change, and complete tasks. Role-based access is also available to avoid mistakes. Depending on their access, team members can initiate, update, or review changes.

Automated workflows

Most change control software comes with the option to automate parts of the workflows, streamlining the process. An ideal predesigned, adjustable workflow eliminates manual task distribution and handovers. Managers can assign and follow up tasks with minimal input with automated processes and notifications.

Reviews and audit trails

A huge part of change control is to ensure that the right authority oversees and approves all changes. This includes execs, QAs, marketing, etc. Most change control software has tools for reviewing and approving change control requests from appropriate personnel before they are initiated.

Most software also offers 21 CFR Part 11 compliant electronic signatures. A detailed record is kept for regulatory compliance and CAPA. Automated recordings keep timestamped logs of all changes, ensuring easy traceability. A detailed log and cloud documentation make audits a breeze.

Documentation management

Change control software is also a tool for seamless data transfer and documentation. Most software comes with automated record-keeping for all changes.

Moreover, many advanced ones, like Scilife QMS software, also have the option to upload necessary documents to the shared interface. This alone takes out hundreds of paper trails and makes it much easier to organize, trace, and make accurate changes. Links to the associated documents for each change request (SOPs, protocols, clinical data) can be added to further digitalize the process.

Regulatory compliance

Regulatory compliance is usually a headache during change implementations. Using software a company can meticulously document all change details for regulatory submissions and audits. Some software comes equipped with templates for regulatory submission documents or for clinical report handling.

Reporting

A huge time-cutting feature of regulatory software is its organization tool. Since all change requests and updates are on the same interface, the whole team can be informed about the ongoing processes.

An ideal change control software will have reports on change statuses, task notifications, approvals, and task completions. Having all this in one place cuts time for everyone involved. Not to mention, advanced change control software automatically sends notifications to individuals for overdue tasks, making overall management even easier.

Risk assessment

Some advanced change control software has built-in tools for risk management. Tools such as risk and impact assessment tools can be game changers for trying out new minor or major changes in operation or production.

Collaboration tools

Having a cloud-based change control tool allows for seamless collaboration. Features like topic discussions, comment threads, and document uploads promote cross-department collaborations.

For life sciences, the involvement of various departments like QA, manufacturing, research & development, and clinical trials is all equally crucial and difficult to maintain. Change control software solves this issue by allowing information transfer, assessment/approval, and task assignment to be done on one platform.

Cybersecurity

Security is a concern for all cloud-based processes and one of the major reasons companies might hesitate to use change control software.

Advanced software, like Scilife's, solves this issue by providing tiered access to its users. For example, only high-tiered users, like administration, will have access to creating edits or confidential documents.

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Applications of change control software in the life sciences

Change control is necessary for every life science industry. Below we dive into how it’s key for the pharmaceutical and medical devices industry.

Change control for the pharmaceutical industry

Pharmaceuticals will often manufacture new formulations or make minor changes to older methods (temperature change or addition of a flavor ingredient, for example) that need careful monitoring.

A change control software allows you to monitor minute changes that are being made and track the results, comparing them to previous reports. This process is also invaluable during raw material source changes, equipment changes, and even technician changes.

An otherwise long process can be done in hours with a change control software and customized workflow. Airtight change control prevents product quality from varying and catches potential adverse events.

Change control software for medical devices

For medical devices, change control software can be used for all purposes from testing minor design changes in the device to changing the entire technology of the device.

Medical tech is rapidly evolving. Therefore, robust change control software not only allows for smooth transmission onto new technology, it also keeps track and records of all models. This is also a useful tool during software updates and regulatory submissions.

How can life sciences organizations benefit from change control software?

Some companies use paper-based processes, which can be a nightmare to manage change while keeping up with regulatory compliance. Manually handling change can be incredibly inefficient as cataloging and filling out paperwork by hand alone can take weeks of your employees’ time. This manual process cannot only cause major setbacks when implementing change but also the risks of error are exponentially high in manual processes.

Poorly controlled change is reflected in poor product quality. Disorganized change in processes affects all phases of product development, and a fall in regulatory compliance and quality assurance is sure to follow. 

Conclusion

Change control software is the new norm in life science operations. As most proceedings are done in digital format, using structured, highly customized software will allow your company to thrive without stumbling on filing or regulatory issues. Instead of wasting hours to manually process change at your organization, here at Scilife, we believe that your team’s efforts could be better spent elsewhere. 

Want to learn more about change management software? Watch our free webinar: GMP Change Management – Jumping on the Fast Track from Deviation to Resolution.