In this piece, we outline key considerations for writing clear and actionable work instructions for Veeva Vault Users. 

Standard Operating Procedures (SOPs) and Work Instructions (WIs) are similar documents businesses use to support safety and understanding of how work procedures should be completed. While they serve similar purposes, there are important distinctions between the two. SOPs provide a broad overview of how to complete processes, while WIs are detailed step-by-step guidelines that explain how to perform specific tasks to ensure clear and actionable execution. Since WIs are clearer, they help reduce the risk of errors and improve training and quality.  

The Importance of Clear and Actionable Work Instructions (WIs) 

Clear and actionable WIs are crucial for ensuring safety, efficiency, consistency, and improved productivity. Without clear work instructions, employees might interpret tasks differently, leading to inconsistencies in quality, safety risks, and delays. To avoid this, companies are using software solutions, such as Veeva Quality Docs.  

What is Veeva and How Can it Help? 

Veeva is a cloud-based management platform that provides solutions across a wide span of industries, largely focusing on life sciences. Some of these solutions include data management during clinical trials, commercial operations to help manage customer relationships, and quality management to help manage quality processes. Additionally, Veeva offers an electronic document management system (eDMS) for items such as WIs. Utilizing Veeva can significantly streamline the process of writing WIs by proving a structured, compliant, and collaborative environment for document creation and management. Some if its key components include: 

1. Standardized Templates  

Veeva allows users to load their current templates into the platform to be used for WIs. Standardizing ensures consistency in both formatting and content structure.  

2. Version Control and Audit Trails 

Veeva utilizes version control, which tracks every change that is made to a WI to ensure there’s a clear history of edits, reviews, and approvals where applicable to the workflow. Veeva is also equipped with an audit trail functionality to provide a transparent record of who made what changes and when they made them. 

3. Collaborative Review Workflow 

Automated workflows help to route WIs for review and approval to ensure they go through the correct quality and compliance checks. Users can also collaboratively work on a single document in real time, helping to reduce time spent reviewing and editing.  

4. Compliance and Regulatory Alignment 

Veeva has electronic signatures enabled, which ensures regulatory compliance with FDA 21 CFR Part 11. 

5. Easy Distribution and Searchability 

Once approved, WIs can easily be published and made accessible to employees. WIs can also easily be searched and retrieved by using tags, roles, tasks, and keywords to help reduce time spent looking for the correct document. 

While Veeva helps to streamline work instruction management, it’s still essential to ensure clarity and effectiveness in the writing process, too.

How to Write Clear Work Instructions in Veeva 

Implementing work instructions requires several key steps to ensure they are clear and actionable. Below are the steps that should be followed when creating WIs in Veeva. 

1. Access the Work Instruction Template 

The first step to developing clear and actionable WIs is to access the work instruction template if it’s available. Using a standardized work instruction template ensures consistency for all instructions. If a template isn’t available, you may create a new document using your organization’s established structure to support consistency.  

2. Define the Purpose and Scope 

The next step is to define the purpose and scope of the work instruction. This includes stating the goal of the task and identifying its intended users with their responsibilities. It’s also important to mention any governing procedure and documents, materials, or training needed to complete the work instructions effectively. 

3. Write Step-by-Step Instructions 

Next in the process is writing the step-by-step instructions. These steps are written under the “Procedure” section of the template. When writing the work instructions, it’s important to use clear, concise, and actionable language that will guide the user through each task to avoid uncertainty. Each step should be written in sequential order using specific actionable verbs such as “Click,” “Next,” or “Finally” to prompt the action. Additionally, avoid using vague terms such as “handle appropriately” or “as needed,” as this can lead to unsureness.  

Additionally, each step should focus on a single action at a time to prevent confusion or misinterpretation. Rather than combining multiple sentences, such as, “Click the blue ‘Create’ button then click ‘Document,’” break it into two separate steps. If a written step seems confusing, adding visual aids, such as annotated screenshots, can be used to help avoid unnecessary confusion. In addition, creating warnings, tips, or reminders beneath perplexing steps can also reduce uncertainty. 

Consistent formatting is also imperative. Use numbered lists for steps as well as consistent font, spacing, and headings throughout the work instructions to make it easier to follow. Below is an example of how good formatting should look for a work instruction.  

1. Procedure
  1.1 Writing a Work Instruction
     1.1.1 Define the Purpose
       1.1.1.1 The purpose of a work instruction should clearly define why the instruction exists and what it aims to achieve. 

You’ll also want to test the work instructions to ensure that the steps are accurate and easy to understand. 

4. Route for Review and Approval 

Once the work instruction is drafted, it should be routed for review and approval. During the review phase, document owners can track the review progress by seeing who has or hasn’t completed their assigned review tasks. They’re also able to respond to annotations, recall the document from the review process if there are changes that need to be made, and cancel the workflow if needed.  

Reviewers are granted different capabilities than document owners. Reviewers with read-only access are only able to view the document, while those with full access can add annotations, such as comments or suggestions, and can also view other annotations. Direct edits aren’t permitted during review; annotations must be used to suggest changes. Users with full access are also granted the ability to complete the “review document” task. Although all annotations in the document don’t need to be addressed before sending the document for approval, it is best practice.  

After all reviewers have completed their tasks, the document can now be put into the approval phase. In approval, individuals assigned the approval task can view and leave annotations just as the reviewers. Approvers are also able to approve or reject the document. Once all approvals have been completed, the document is now in “Effective” status and can easily be found by searching the documents tags, roles, tasks, or any keywords.  

Final Thoughts 

While SOPs and WIs share similarities, it’s important to understand the differences. Clearly written WIs are detailed step-by-step guidelines used to minimize errors by enhancing safety, efficiency, consistency, and productivity.  

By leveraging eDMS solutions such as Veeva Quality Docs, organizations can ensure users have access to standardized instructions that support consistent training, improved quality, and overall operational excellence. To discuss best practices for WIs or how digital solutions like Veeva can support your operations, connect with our team today. 

Contributions by Nikki Trammel