Change Control SOP Software Solutions

Automate and effectively manage every step of the change control process from form submission, starting with standard operating procedures (SOPs), through actual implementation, verification, and close of a project.

Manual and paper-based change control processes are difficult to manage and lead to compliance and product failure. Using an integrated SOP software solution, you can automatically organize documents and retrieve them on demand. You can maintain an audit trail with time stamps and e-signatures that provide regulators with verifiable proof of compliance.

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Frequently Asked Questions About Change Control SOPs

What are the 3 main objectives of change control?

The three main objectives of change control are:

1) To ensure that only approved changes are done according to standard operating procedures (SOPs).

2) Document reproducible changes to fulfill regulatory requirements.

3) Enable continuous improvement of product quality. Change control SOP software streamlines these objectives.

How do I write a change control SOP?

A good change control system forces SOP managers to think through processes and examine how changes might affect product, personnel, production, and equipment – and document them. SOP software provides standard templates that include these details. An integrated QMS system can allow you to see how changes affect your system dynamically in real time.

What are the 4 steps in SOP creation?

When you develop or change an SOP, follow these four basic steps to establish standardized practices:

1) Get stakeholders together to align business and regulatory objectives.

2) Design, observe, and document procedures.

3) Complete internal and/or external reviews and approvals.

4) Publish the SOP.

Free Change Control SOP Resources

Select all the resources you’re interested in downloading.

Industry Brief: Ensure Compliance by Digitizing Change Control Industry Brief: SOP Management as a Compliance Tool in FDA and ISO Environments
White Paper: Writing and Enforcing Your SOPs for GxP Compliance Success
Free Templates: Basic Procedure SOP Template (Word Document)

Challenges With Change Control SOP Management

A change control SOP is necessary to prevent inappropriate or uncontrolled modifications. “Say what you do, do what you say, and be able to prove it.” While this sounds simple, implementation can be complex.

What makes managing change control so challenging? There are many factors, but the following are the most common issues:

Disparate Systems and Databases

Change control processes require collaboration with people in different organizational areas. Business units commonly use separate tools and databases to perform tasks and store documents, making it difficult to share essential data. Effective SOP management requires that you maintain a centralized repository. Using MasterControl SOP software, you can store all documents, including structured data, in a single secure system. Authorized users can simultaneously access and mark up documents anytime from anywhere. Stakeholders can access updates in real time. You can even integrate your change control SOP with existing enterprise applications like enterprise resource planning (ERP) systems that utilize API technology.
Communication Issues

SOPs serve as a fundamental means of change control communication for all levels of the organization. Documentation reviews and approvals are difficult when stakeholders are dispersed across multiple locations. This is compounded by delayed or stalled communication between stakeholders, failure to follow up or escalate change requests, and delayed notifications of changes made by suppliers. Using compliant cloud-based SOP software, you can complete reviews and approvals remotely and easily ensure that all the necessary electronic signatures are provided. MasterControl provides a virtual collaboration workspace, which eliminates the need for in-person meetings and reviews.
Incomplete Documentation

It is difficult and time-consuming to find and retrieve necessary data to support a change and update the documentation. The proposed change can be delayed by an outdated record or one that does not include its revision history. Important steps, such as testing, can get missed or duplicated because the documentation has not been updated with results of previous testing. Using SOP management software ensures that documentation can remain a stable tool. Automated solutions that include standard templates help ensure nothing is missing.
Fragmented Change Control

Without efficient SOP management it can be difficult to manage the numerous interrelated elements across multiple departments – or even within a single document. Using MasterControl SOP software, you can keep document reviews moving – as well as facilitate the actual changes when they become necessary. It is designed to streamline and effectively manage every step and escalation in the change control process. Regardless of how many people are involved, everyone can be notified and review changes in real time.
Compliance and Product Failures

Change control is imperative for companies in regulated industries. It’s getting more and more difficult to manage everything involved. In inadequate system and processes can cause internal confusion, noncompliance, or worse, a product recall or a product liability lawsuit. Integrated change control tools help to establish a culture of quality and efficiency throughout your organization.
MasterControl’s proven digitized processes and automation enable you to achieve desired results and reproduce them predictably. Using SOP software, you can establish and efficiently maintain vital standard operating procedures to achieve compliance, develop products, and get them to market sooner.

Change Control SOP Tools for You

You’ve got questions about SOP software solutions. Our goal is to help you succeed in your change control SOP development and execution. We can help you automate this process.