Quick Answer: For pharma and biotech teams, inconsistent documentation creates serious operational problems. It slows approvals, increases rework, raises compliance concerns, and can contribute to safety risks. The key is to address writing and documentation problems systematically:
- Build standardized writing and review workflows
- Use consistent templates, style guidelines, and approval standards
- Break down siloed communication among departments
- Train teams in specialized pharmaceutical technical writing skills, not just generic business writing
Inconsistency is a Quality-Killer at Pharma and Biotech Firms
Yet inconsistencies in records, reports, and other written materials are commonplace. When writers approach their work without universal guidelines or when different teams silo information or processes from other teams, inconsistency is inevitable.
But written documentation is a core operational function at organizations that deal with health and science, with direct impacts on regulatory compliance, human health and safety outcomes, product quality, and business performance down to the bottom line.
Ultimately, organizations that standardize documentation create far more predictable outcomes. So, how can your team standardize its documentation to boost productivity and improve outcomes?
Documentation problems generally emerge at three different levels
First, we need to understand where the problem is originating. In general, professional writing problems tend to emerge out of three possible dimensions:
- People problems, where writers, reviewers, or approvers lack the necessary writing and/or reviewing skills or produce inconsistent work.
- Process problems, where workflows themselves create confusion, delays, or variation.
- Strategy problems, where documents fail because they’re poorly aligned with organizational goals or reader needs.
(We discuss this people-process-strategy problem-solving framework in more detail here).
Organizations seeking to standardize documentation should usually start at the process level. Even highly capable scientific teams and proficient writers will struggle if documentation systems supporting their work are fragmented or inconsistent.
1: The first step is creating clearly documented writing processes
Organizations should start by defining step-by-step workflows for producing, reviewing, approving, and maintaining different document types. These workflows should include responsibilities, review expectations, timelines, escalation procedures, and version control standards.
Remember to document writing processes comprehensively, not just the act of drafting, but everything else too. For example, review systems must also be standardized. If reviewers/approvers bring different criteria or expectations into the process, inconsistency will result.
2: Templates and standardized frameworks also play a critical role
Common document types should follow consistent organizational structures, formatting conventions, terminology rules, and review expectations. Templates reduce ambiguity and help teams produce stronger documents more efficiently. We recommend the PROS approach in creating these templates and frameworks:
- Problem (P): Define the documentation and communication problems the organization needs to solve.
- Readers (R): Understand who will consume the documents and what those readers need.
- Outcomes (O): Clarify the operational, compliance, or business outcomes the documentation must support.
- Strategy (S): Build documentation processes and standards that align with those goals.
We use this same framework to develop our professional writing services to align with real-world organizational needs. It also provides a great structure for developing baseline writing standards, workflows, and processes.
3: Many organizations benefit from bringing in outside expertise during this process
Third-party experts can be especially useful when teams aren’t sure where to start or can’t easily identify what’s working and what isn’t. External trainers, consultants, and professional writing specialists often identify workflow gaps and communication problems that internal teams no longer notice.
For help auditing your current processes, we recommend an audit such as our patented, proprietary PROS™ Communication Diagnostic®. This takes an analytical, problem-solving approach to improving writing, reviewing, and tools issues. The focus is on uncovering root cause issues, just as any pharma or biotech firm would do if their research and product development ran into issues.
4: Make sure your writers have the tools they need to support them so that they can write at their highest potential
While a lack of standardized documentation in writing output tends to be a process problem, nothing is going to fix unworkable documents if your team writes poorly. Even brilliant scientists sometimes need help writing clearly. So, a cornerstone of any comprehensive strategy to standardize documentation is to invest in writing training (pharmaceutical writing workshops specifically) for your team members to ensure they’re writing at their best.
We don’t mean grammar instruction, though. We mean learning how to think and write critically, strategically, and in a goal-oriented way. “Without prior scientific technical writing training, that was a challenge,” one scientist told us after one of our writing workshops.
The downstream effects are substantial
Standardizing documentation is impactful for any organization, but it might make even more of a difference for pharma and biotech teams than others, because we’re not talking about abstract or incremental effects here.
Poorly written and inconsistent technical documents can cause problems and even pose potential safety risks for customers, peers, colleagues, stakeholders, and others. Meanwhile, ensuring all written materials meet the same quality and style standards and are all equally aligned with organizational goals yields significant benefits.
- Standardization can ensure all your teams are always working from the organization’s best-established practices. “If process masters (best performers in a process) ways of performing their own tasks can be well documented, then a company will be able to standardize its operating procedures in their best forms,” says business management professor Mustafa Ungan. “And, when employees follow these procedures, variations will be minimized, and the best quality products or services will be offered to customers.” This is just as true of writing processes as any operational process.
- Standardization in writing boosts reputation, trust, and credibility. “You want to be as impressive in writing as you are in person,” says Barbara Wallraff, author and former senior editor at The Atlantic. She’s right, but that also means being consistently impressive.
- Standardization can even benefit team morale and productivity. “If managed properly, standardized work establishes a relationship between people and their work processes,” writes author Walter McIntyre in Lean and Mean Process Improvement. “This relationship can enhance ownership and pride in the quality of work performance. The result is high morale and productivity.”
To learn more about strategies for standardizing and improving the start-to-finish communication processes at your organization, contact Hurley Write for a custom, no-obligation consultation, or learn more about the Hurley Write PROS™ Communication Diagnostic®.
Frequently Asked Questions
Why is it so difficult to standardize documentation across pharma and biotech teams?
Pharma and biotech organizations often involve multiple departments, technical specialties, and different review and approval layers working on the same documents, all of whom could have different expectations, workflows, and communication habits.
In addition, the subject matter is often complex and technical in nature, and different writers, reviewers, and readers may have different levels of knowledge and understanding. Without standardized writing processes, inconsistency naturally develops.
Do pharma and biotech firms need specialized writing training?
Yes. These organizations operate in highly regulated, scientifically complex environments where unclear or inconsistent documentation can create compliance risks, slow approvals, increase rework, and even contribute to safety concerns. As a result, generic business writing instruction won’t be enough.
If pharma and biotech teams want to improve consistency and standardize documentation, they need writing services specifically designed for their unique operational challenges. Learn more about what sets this field apart in writing training in our primer, “Why Pharmaceutical Technical Writing Requires a Different Skill Set (and How to Build It).”
What’s the best first step to standardize documentation at a pharma or biotech company?
The best starting point is usually to evaluate the organization’s current writing and review processes through a communication audit. Many organizations discover that inconsistency comes from fragmented workflows, unclear review expectations, disconnected communication systems, or a lack of standardized templates and guidelines.
Once those gaps are identified, organizations can begin building standardized workflows, document frameworks, approval systems, and writing standards that align teams around consistent expectations and outcomes.
