The ultimate guide to technical writing in the life sciences

Introduction

Despite its crucial role in life sciences, college curricula often overlook technical writing. However, life sciences professionals are expected to possess this skill and demonstrate it at a level that frequently exceeds their capabilities. This gap in experience creates a twofold problem:

1. Writers struggle to produce clear, accurate, and effective documentation.
2. Readers, often lacking expertise in technical writing themselves, may not recognize the difference between well-crafted and subpar documentation.

The result is a pervasive issue of mediocre technical writing that fails to convey its intended message accurately.

Poorly written documentation is prevalent in many life sciences organizations, particularly within their Quality Management Systems (QMS). This leads to difficulties locating information, confusion among workers about their responsibilities, non-conformities, and documentation that is hard to defend during audits. More concerningly, it poses significant risks to both product quality and patient safety.

The first step toward improvement is recognizing the importance of clear, accurate, and effective technical writing in the life sciences. Addressing this often-overlooked skill can enhance your organization's operations, ensure compliance, and improve outcomes in this critical field.

This article will explore the essentials of effective technical writing, its crucial role in compliance, and the common challenges faced in the field. We will also outline the five key phases of the technical writing process and share some general best practices. By the end of this article, you will have a clear understanding of these phases and be well-equipped to create a wide range of technical documents, including manuals, procedures, work instructions, deviations, root-cause analyses, CAPAs, and more.

What is technical writing for life sciences?

Technical writing is often described as the art of simplifying the complex. This seemingly straightforward definition encompasses a wide range of skills and characteristics that address diverse human performance needs. It's important to understand that technical writing is not an exact science or merely about using technical jargon.

At its core, technical writing is about conveying information quickly, accurately, clearly, and succinctly. The effectiveness of communication—how it is crafted, understood, and received—relies heavily on the skills of the technical writer.

Source: https://books.google.hr/books?id=OXSbj25RSrwC&pg=PA17&cad=4#v=onepage&q=attributes&f=false 

What is technical writing used for in the life sciences?

Technical writing plays a vital role in the life sciences for several reasons. Primarily, producing documents required for regulatory compliance and safety is essential. Given these documents' impact on public health and safety, technical writers must communicate information clearly and accurately.

Technical writers in life sciences are responsible for creating a wide range of educational materials. Some examples include: 

• User manuals
• Root-Cause Analyses (RCAs)
• Standard Operating Procedures (SOPs)
• Work Instructions (WIs)
• Change controls
• Corrective and Preventive actions (CAPAs)
• Batch records
• Reports & journal papers
• Label information

Source: https://books.google.hr/books?id=OXSbj25RSrwC&pg=PA17&cad=4#v=onepage&q=attributes&f=false 

What makes an effective technical writer? 

The goal of technical writing is not to entertain or to highlight the writer's educational background. Instead, excellence in technical writing is demonstrated through the ability to convey complex information in a simple, understandable manner for a diverse audience. This skill is especially crucial in highly regulated fields, such as pharmaceuticals, biotechnology, and medical devices. 

Clarity in technical writing minimizes human error, enhances process quality, and is essential for audits and error analysis. Documents must be comprehensive and remain relevant over time. 

To be truly effective, a technical writer must consider several key aspects of the craft. They must adopt and apply a specific form and style relevant to their industry, as the requirements for pharmaceutical production documents differ from those for scientific journal articles.

Understanding the audience is paramount. Writers must gauge their audience's needs, abilities, level of understanding, and proficiency in the language used. An unwavering dedication to accuracy and consistency is paramount. Finally, collaboration is key to ensuring accuracy by gathering insights from subject matter experts.

Why strong technical writing skills are essential for regulatory compliance 

Documentation is the backbone of good manufacturing practices (GMP). It serves as a tool for verifying quality, investigating issues, and determining the safety and efficacy of a product. 

Even minor alterations can transform a safe product into a harmful one in the pharmaceutical industry. Therefore, every manufacturing process step must be meticulously recorded and validated. Any inaccuracies, data mix-ups, or procedural deviations can compromise the integrity of the product, potentially leading to adulteration.

Consider the impact of an unclear or erroneous batch record. Such mistakes can render a product unusable, resulting in financial losses and damaged client relationships. More seriously, these errors could harm employees or, if undetected, pose risks to patients, potentially leading to severe injury or even death. 

This is where precise and effective technical writing plays a significant role. Documentation ensures content is clearly understood and that tasks or procedures are performed accurately. The technical writer is responsible for ensuring clarity and accuracy in these documents.

FDA expectations for writing 

While the FDA does not explicitly regulate the quality or clarity of writing, it emphasizes the importance of thorough documentation. The agency's guiding principle is, "If it’s not written down, then it didn’t happen." 

For FDA-regulated manufacturers, documentation is the primary means of demonstrating compliance with regulations and communicating activities to the agency. Poor writing can lead to miscommunication, which is often at the root of issues identified during inspections of pharmaceutical and medical device manufacturing facilities.

FDA Warning Letters frequently cite failures to explain, justify, or provide sufficient information as evidence of inadequate writing skills. These issues highlight the critical role that effective technical writing plays in ensuring regulatory compliance and maintaining the integrity of manufacturing processes.

What does a good document look like for the FDA, then? 

It is not enough for a company to know its operations are scientifically valid and compliant. The information must be articulated in a way that FDA investigators can easily understand.

If the documentation fails to communicate compliance effectively and properly record-keeping, it will likely result in issues during an inspection, potentially leading to 483 observations from the FDA.

Understanding regulatory requirements in the life sciences as a technical writer

Technical writers in the life sciences must understand the industry's regulatory framework and stay updated on any changes or amendments to ensure their documentation remains compliant. 

Regulatory inspectors often spend significantly more time examining a company’s documents and records during inspections than assessing the physical operations. This documentation builds a detailed picture of what a manufacturing function has done in the past and what it is currently doing, providing a solid foundation for planning future activities. 

Adequate documentation enhances the visibility of the quality assurance system, which is critical for maintaining compliance.

GMP and technical writing 

A fundamental principle of Good Manufacturing Practices (GMP) is to "write good procedures." But what does this mean?

In the pharmaceutical sector, GMP dictates that instructional materials, such as Standard Operating Procedures (SOPs), must be error-free and well-written. Creating SOPs is a regulatory requirement frequently referenced in FDA, ISO, and ICH guidelines. 

Many parts of Title 21 of the Code of Federal Regulations (CFR) outline these requirements, emphasizing the need for clarity in manufacturing documentation, problem reporting, laboratory test methodologies, and batch production records. All instructions must be crystal clear to ensure compliance and operational efficiency.

Moreover, adherence to Good Documentation Practices (GDP) is essential for all documentation and records utilized throughout the manufacturing process, including supporting procedures such as quality control and assurance. Whether navigating GMP, Good Laboratory Practices (GLP), or other regulatory frameworks, mastering the craft of technical writing is vital for ensuring compliance and fostering operational excellence in the life sciences industry. 

The challenges in technical writing 

The scarcity of technical writing skills in the industry 

Ensuring that company documents are well-written presents numerous challenges, primarily due to the need for strong technical writing skills. Although the industry recognizes this issue, it is seldom openly discussed. 

Finding an employee with deep content knowledge in their field and the ability to craft clear technical documents is like finding a unicorn. It is also rare to find those who have completed formal training in technical writing, as many colleges do not offer it as a specialized course within their English departments.

Lack of training and focus

Training in writing principles and techniques is typically absent from educational programs for manufacturing and quality assurance employees. These skills are overlooked during the hiring process as well. The rapid advancement of technology may have inadvertently sidelined effective communication, turning clear writing into a lost art that is now ripe for revival. 

The overlooked importance of technical writing skills 

Many companies may not fully appreciate—or even recognize—the critical importance of good writing. In industries like pharmaceuticals and medical devices, there is a tendency to prioritize scientific and technical expertise over the clarity of communication. 

This focus can lead to neglecting the regulatory significance of well-structured and purposeful written documents, which are crucial for internal and external stakeholders.

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Recommended learning: Unlock the secrets to user-friendly writing! Watch our expert-led training video on plain language techniques and discover how to empower your team to create clear, user-friendly documents.

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Technical Writing Phases

In this section, we will explore the technical writing process as outlined by Kieran Morgan in her book, Technical Writing Process: The Simple, Five-Step Guide That Anyone Can Use to Create Almost Any Piece of Technical Documentation, Such as a User Guide, Manual, or Procedures.

Morgan identifies five key steps in the technical writing process: Plan, Structure, Write, Review, and Publish.

Phase 1: Plan

Before you begin writing, the first step is to create a Documentation Plan. This essential document serves as a roadmap, outlining the deliverables you will produce. Consider this phase as the project management stage of your document.

The Documentation Plan defines the project's scope, identifies the target audience, lists the required deliverables, and outlines the process you will follow to complete the documentation.

Here are the key factors to consider in the planning phase:

Scope, Stakeholders, and Process

In this phase, you'll define the scope of your project, identify key stakeholders, and establish a timeline. If templates are available, now is the time to gather the necessary information and ensure compliance with relevant regulations.

Clarifying roles and responsibilities is also important. Identify the subject matter experts, team members, and other stakeholders involved.

Audience

To create an effective technical document, you must have a deep understanding of your audience. During this phase, focus on your target audience—the individuals who will be reading and using the document. Consider what they need to know and how best to convey that information.

Remember that there are two types of audiences: primary and secondary.

• • Primary Audience: This group will actively use your document, such as in a training program.
  • Secondary Audience: While this group may read your document, they won't use it directly. An auditor, for example, might fall into this category.

An SOP (Standard Operating Procedure) often serves primary and secondary audiences. The primary audience might include company employees or department members, while the secondary audience could be internal or external auditors interested in the process.

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Bonus Resource: Download Scilife’s SOP template to streamline your documentation process and ensure consistency in your standard operating procedures.

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Tips for identifying your audience

• Interview Subject Matter Experts: Speak with those familiar with the audience to gain insights into their challenges, needs, and user experience with the process, technology, or product you're writing about.
  
  
• Understand their needs: Determine the level of detail your audience requires, how they process information, and how they will use the document. This will help you tailor your writing to their needs.
  
  
• Consider usage: Remember that people typically use technical documents as references, work instructions, or guidelines. Tailor your content accordingly.

To create a comprehensive audience profile, ask yourself:

Techniques & Tools

Before you begin writing, carefully consider the techniques and tools you will use. Selecting the right tools and methodologies upfront can significantly enhance the efficiency and quality of your technical document.

Style Guide

Always seek out existing style guides or templates before starting. These resources provide a valuable reference and ensure consistency and adherence to established standards throughout your document.

Schedule: Timeline

Establish a clear timeline for all deliverables and create a documentation schedule. Incorporate status tracking to monitor progress and ensure the project stays on track.

Before you move on to the next phase 

Once the plan is prepared, the technical writer should schedule a meeting with the manager and other stakeholders to review and refine the Documentation Plan. This meeting is crucial for reaching a consensus and ensuring everyone is aligned with the plan.

It's also recommended that a spreadsheet titled "Matrix of Deliverables” be created. This document should list every required deliverable and its key attributes, providing a clear overview of all the documents that need to be written.

Phase 2: Structure

Now, let’s discuss the structure of your technical document. The structure corresponds to the various levels of headings in the final manuscript. It's advisable to use specific templates with predefined headings tailored to the type of document you're creating (e.g., deviation, CAPA, SOP, complaint).

If a table of contents is required, create one and review it with subject matter experts and stakeholders. This review helps ensure the document’s structure is clear and aligned with its purpose.

Depending on the document type, you might choose different approaches to structure it: narrative, process-based, library, or system-based.

Narrative structure

The narrative structure comprises three main sections: an introduction, a main body, and a conclusion. In this format, topics are presented sequentially in the main body, one after the other. While this structure is not commonly used in technical writing, it is frequently employed in academic papers, textbooks, or reports.

Process-based structure

A process-based structure organizes documentation around a sequence of activities or use cases, providing a clear roadmap of how tasks are performed to achieve a specific outcome. 

This structure is typically used for process and procedure documentation within Quality Management Systems. To create process-based documentation, you need to use a four-step approach.

1. Analyze Information

• • Collect all relevant information about the topic, including specifications, guidelines, and requirements—and analyze it. This step ensures a comprehensive understanding of what needs to be documented.

2. Create a high-level process model

• • Develop a high-level process model, such as a flowchart or diagram. This model should outline the entire process from start to finish and serve as the foundation for your document’s table of contents.
  • Include distinct boxes or nodes representing key activities or tasks. Avoid complicating the diagram with too many levels; two levels of detail are usually sufficient.
    
    

Inside each box of the high-level diagram, describe the activity using a clear verb-noun format. This imperative mood helps in making instructions direct and unambiguous. Examples include:

• • Write a list of specifications
  • Create a validation report
  • Inform the QA department

3. Validate with Subject Matter Experts

• • Review and refine the process model with subject matter experts. Organize a meeting or workshop to discuss the model, make necessary adjustments, and document any changes. Use tools like whiteboards or digital apps for record updates.

4. Develop the table of contents

• • Translate the finalized process model into a structured table of contents for the document. Include headings and subheadings that correspond to each part of the process model.
  • Begin the document with an introduction section that provides context and outlines the purpose of the documentation.

System-based structure

The system-based structure organizes technical documents, which is particularly useful in manuals and specifications documents. 

This structure focuses on describing the components and interactions within a system. It is typically found in technical manuals, where each part of the system is detailed separately to provide a comprehensive understanding of the entire system. 

While useful for technical specifications, the system-based structure may not align directly with the needs of QMS documents, which require clear process flows and procedural documentation.

Library Structure

The library structure organizes content into a collection of independent documents or articles, typically found on websites, blogs, or online newspapers. Each document is tagged with metadata, including the title, author, publication date, topic, project, or department.

Example: A document might be a monograph detailing analytical tests and specifications for product XYZ. This document would include chapters dedicated to various aspects of the analytical procedure and acceptance criteria for each test, such as identification, loss on drying, impurities, and assay.

Users can easily access documents in a library structure through keyword searches. However, it is important to note that the library structure is generally not used for documents related to a Quality Management System.

Phase 3: Write

With your plan and document structure in place, it’s time to start writing! Here are our top 5 tips to guide you as you start drafting your document:

1. 1. Plan and map out your writing structure:
      • Before you start writing, finalize your document's structure with a clear table of contents. This will serve as your roadmap, reducing writing time and ensuring a logical flow.
        
        
   2. Leverage templates and resources:
      • Create your document structure using a combination of templates, your table of contents, and other relevant materials. These resources can provide a strong foundation for your first draft.
        
        
   3. Start with a draft, then collaborate:
      • Begin with an initial document draft. Remember, technical writing is a collaborative effort, so expect to review, test, and revise the draft with subject matter experts multiple times.
        
        
   4. Gain topic familiarity:
      • Make sure you have a solid understanding of the topic. Use guidelines, standards, and product guides to inform your writing. Be cautious when repurposing information—ensure it’s current, accurate, and suitable for your document.
        
        
   5. Use a Style Guide from the start:
      • Don’t wait until the end to apply your style guide. Adhere to it from the beginning to maintain consistency. For example, consult the European Pharmacopeia’s technical guide to ensure compliance if drafting a specifications document.

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Bonus Resource: Download Scilife’s Work Instruction template to create clear, actionable work instructions that enhance workflow efficiency and accuracy.

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Writing Techniques 

To streamline the writing process, consider employing these key techniques:

• • KISS (Keep it simple, stupid): Focus on clarity and brevity to ensure your message is easily understood.
  • 5W1H (Who, What, When, Where, Why, How): This framework covers all essential details comprehensively.
  • Plain English: Write in clear, straightforward language to enhance readability and accessibility.

 KISS (Keep It Simple, Stupid!)

With origins in military practices, the KISS principle emphasizes the importance of creating straightforward and clear documents aimed at a broad audience rather than focusing solely on experts. This approach does not imply that your readers lack intelligence; instead, it acknowledges that they may be unfamiliar with the subject matter, new to the team, or simply need to grasp essential information to complete a task effectively. When unsure of your audience's level of expertise or training, applying the KISS principle can be a valuable strategy.

Plain English

The Plain English approach focuses on writing clearly and straightforwardly, avoiding complex vocabulary and unnecessary jargon. Short sentences and simple language enhance readability and ensure a broad audience easily understands the content.

The Five W’s and One H

This technique is simple, specific, and effective for introductions and overviews, originating from journalism to ensure you capture key elements of a story. Aim to cover the Five W’s and One H in a single paragraph.

• • Who is the audience? Is there more than one audience? Is the audience primary or secondary?

Remember that the primary audience is the target audience. These people will receive the communication or use the documents (e.g., operators and lab analysts). Your secondary audience consists of readers who do not typically use the documents. They are reviewers, approvers, or auditors, for example.

• • Why does the audience need the documentation? Look for the documentation's solutions to the audience’s needs, problems, or issues.
  • When will the audience use the documentation? You should map out the journey of when the audience interacts with the process or product.
  • Where and how will the audience use the documentation? This determines the format, language, and requirements.
  • What is important to the audience? You need to check the audience’s priorities for the product or process.

Example to nail down your 5 Whys and H

Use this framework to clarify your writing:

This [PROCEDURE/PROCESS] is about [WHAT]. It is performed by [WHO], [WHEN] because [WHY].

For instance,

This SOP is about the use of an infrared spectrophotometer. It’s performed by the Quality Control analysts when performing an infrared test of substances in the laboratory to check their conformance with the identification acceptance criterion.

Phase 4: Review

Many consider the review phase the most crucial part of the technical writing process. Since no one produces a perfect first draft, this stage is vital for refining your document. During this phase, you will edit your draft, assemble a review team, and gather stakeholder feedback. After incorporating the necessary revisions, you can seek approval to publish the document.

It is typical to review a document multiple times before finalizing it. Each review enhances the quality and clarity of the document by checking the style and making necessary corrections. As a result, the table of contents may evolve from the initial structure you defined. To effectively track and manage changes, assigning a sequential version number to each draft is standard practice.

There are two parts to the review process:

Part 1: Editing and Checking

Part 1 involves editing and checking to refine the document and prepare it for publishing. The goal is to ensure the document is as user-friendly and accurate as possible before moving on to Part 2. 

Editing is a multi-step process that includes various levels: rewriting, structural editing, validation, copy editing, compliance checking, proofreading, and layout and format checking. However, this process is broadly categorized into three primary levels: proofreading, copy editing, and structural or substantive editing.

Part 2: Formal Review and Approval

In Part 2, the document undergoes a formal review and approval process by key subject matter experts and other stakeholders who provide the authorization to publish. 

After the review, the document must be formatted according to your organization's template, branding, and style. The choice between a formal or informal layout should be based on the intended audience. Typically, formal documents do not include pictures, cartoons, or colorful aids.

Document layout tips & tricks

• • Use bullet points: Break down long sentences into bullet points to make information easier to digest.
  • Add tables and charts: Visual representations of numerical or ordered data can enhance clarity and engagement.
  • Add diagrams: Use diagrams to illustrate concepts; a single image can convey information more effectively than a lengthy explanation.
  • Use call-outs: Highlight isolated concepts with call-outs that include arrows, lines, or numbers to draw attention to tips, notes, or insights in specific areas.

Phase 5: Publish

The final phase of the technical writing process is an exciting milestone—it means your technical document is ready to be published! 

This phase includes formatting and proofreading, establishing document control, and publishing the final draft. The document should be uploaded to the appropriate document management system, and stakeholders should be communicated with throughout the process.

Technical Writing: Do's and Don'ts

Here are some final rules of thumb to consider as a technical writer:

Avoid assuming prior knowledge

Don't assume your audience already understands the subject. Avoid skipping steps or referencing other materials without explanation, leading to confusion.

Integrate text and visuals

Use visuals to complement the text, especially when describing actions like clicking an icon. Visuals are generally more straightforward and less prone to misinterpretation than lengthy textual descriptions.

Use simple language

Write clearly and directly, avoiding technical jargon. Consider having someone from your target audience review your document to ensure it is accessible.

Use templates

Adhere to standardized templates to ensure uniformity and readability. Templates help organize content and reduce errors, especially in documents like SOPs and validation protocols.

Focus on structure

Organize information with bullet points, readable fonts, and a professional layout. Include a table of contents or appendices for lengthier documents to aid navigation.

Collaborate effectively

Technical writing often involves collaboration with cross-functional teams and experts. Effective teamwork ensures accurate documentation reflects best practices and regulatory standards.

Regularly review your document

Review technical documentation frequently to catch errors and ensure accuracy. Regular updates help maintain the information's quality and reliability.

Commit to continuous improvement and training

Invest in ongoing training to stay updated with industry trends and regulatory changes. Attending seminars and obtaining certifications can help technical writers remain compliant and valuable to their organizations.

Leverage technology

Utilize technology to enhance technical writing. Tools like EQMS offer version control and document tracking, while advanced software provides validation templates and automated workflows to streamline processes.

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Recommended learning: Discover more technical writing tips for deviations, root-cause analysis, and CAPAs!

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Conclusion

Technical writing is not rocket science—it is a learnable skill that can be developed and brings measurable benefits to a life sciences organization.

By creating high-quality content and tailoring documents to achieve maximum clarity, technical writers can help their organization achieve positive results. More critically, they can train others within the company to produce more sound technical documents. 

The ripple effect of well-crafted technical documents extends beyond mere communication; it fosters trust and credibility among clients and customers, ultimately driving business growth. As organizations prioritize clear and professional communication, they will undoubtedly experience increased customer satisfaction, enhanced stakeholder value, improved internal relations, and greater efficiency and compliance. 

Improve the quality of your documentation with Scilife's Smart QMS! Our advanced system goes beyond traditional solutions, offering automated workflows, real-time collaboration, and robust version control.

FAQs

Is writing in the second or third person always preferable? Should the first person (i.e., “we” and “I”) never be used in technical writing? 

In investigation reports, there is a place for the second person (or “we”). However, it is best to avoid writing in the first person or using “I.” The plan should be to write in the third person or describe a series of events impartially. 

Are there tools available to proofread technical texts? 

AI is an option (e.g., ChatGPT), although only some use it. Microsoft Word’s spellcheck function is also a practical option. 

It’s important to note that while AI works well for proofreading texts, you should exercise caution when using it to write content. There can be issues surrounding copyright, accuracy, and the confidentiality of your company’s documentation.

Where, if anywhere, should we use the words “shall” and “should”? 

It depends on the document. In SOPs and WIs, active voice is preferable—but there is no inherent problem with using “shall” or “should” in, say, a root-cause analysis.

Generally, try to avoid vague language. Terms like “shall” or “should” could raise more questions than they answer.

Which technical skills does a technical writer require?

Technical writers can succeed with limited technical skills if they can access a subject matter expert during the writing process. When writing WIs, consulting the people who are performing those instructions is essential. 

How do you effectively prepare documents in multiple languages?

A translator is your best option for GMP documents, which are regulatory documents. For minor GxP documents (e.g., awareness, safety flashes, etc.), online translator tools like DeepL Translate or ChatGPT can be helpful. Some companies even have a secure online translation tool.

The important thing is to always comply with your company’s data safety and security policy.

What kind of grammar should be avoided in technical writing?

Avoid poor grammar, such as misuse of passive voice, lack of subject-verb agreement, and incorrect punctuation. Also, avoid overusing jargon, which can confuse readers unfamiliar with the subject.

What is the goal of technical writing?

Technical writing aims to convey complex information clearly and accurately to a specific audience, enabling them to understand and perform tasks effectively.

How can I improve my technical writing skills?

To improve your technical writing skills, practice regularly, seek feedback, study good examples, use grammar tools, focus on organization, and understand your audience’s needs. Consider taking technical writing courses for additional guidance.