Documentation is Your Key to Success
My first June article discusses a discipline that many startups fail to initiate early. Find out why good documentation practice is critical to your success and some tips on how to get started today!
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One point on which almost all startups fail is establishing a sound documentation practice early. I hear lots of excuses for this flaw – we were working on other tasks, we didn’t know how necessary documentation is, the market doesn’t reward that work, etc. The truth is, you need proof of all types to win grants, engage investors and partners, and get your medical product to market. A good documentation practice, when established in the early days and consistently maintained, doesn’t have to be burdensome to provide compelling proof at every stage of your business. I’ll share my thoughts on the why, what, how, and when of good documentation practice (GDP) in this article.
Why Focus On GDP?
There are three compelling reasons why you need GDP in your business. Let’s review them.
It Captures the Basis for your IP
You need evidence to support your intellectual property (IP) claims. That evidence includes dated records of your ideas captured when you have them. In cGMP manufacturing, we use the acronym ALCOA to remind us how to capture high-quality evidence. They should be Attributable (assignable to a person), Legible (easily readable), Contemporaneous (recorded as they happen, not later), Original (in a hard-to-change format), and Accurate (a true record of the event or activity). Not every document needs this level of care, but the ones supporting your science, technology, and patentable claims do. Don’t forget to keep records of your softer IP – information on your trademarks, copyrightable materials, and trade secrets should be captured in similar detail.
It Ensures Reproducibility
I’m surprised by how often I have to explain to scientists that they need sufficient documentation to consistently reproduce any observations made on their new device or therapy. That includes enough detail so you can train others to perform a task. It’s not enough that the founder can always do something; they must delegate to team members as the startup grows. In some cases, you may need to unexpectedly replace someone with critical skills. For medical devices, capturing your design history before and during development is a necessary part of your product quality requirements. As you move toward commercial production, good documentation ensures you can qualify your equipment and validate your processes, and provides data to support deviation investigations. Unique processes may also be patentable, and the right level of detail will facilitate an application.
It Demonstrates Your Business Skills
Your startup is a business, so naturally, you want to demonstrate to others that it has a sound structure and financial footing. What are your accounting processes? How do you do customer research? How do you maintain your website? Who answers the phone and the mail, and how? Who makes sure everyone has the tools and supplies they need? How do you hire new team members? Neglect in this area of GDP can be catastrophic in due diligence if you don’t have a co-founder agreement, employee agreements that assign IP rights to the company, or critical technology licenses.
What Should You Document?
Start with your master business systems (accounting, operations, marketing, etc.) If your team does a task that contributes to your company, you should have, at minimum, a checklist of steps, what tools to use, and where to find the necessary resources. Records of your bank professional, accountant, and service providers with contact information are invaluable when fixing a problem. Market research, competitive analysis, business model, business plan – these will all change over time, so capturing them as you go will give you reference points for future planning and strategy. Any policies you establish should be in writing. And, you already have a corporate records book, right?
The GDP for your innovative product should capture discovery and development protocols and notes, verbal conferences, reviews, and decisions. Companies often capture these details in a variety of documents, so it’s wise to periodically create summaries of what you know and when you first learned it with cross references to the original record. External communications should also receive attention, including conversations with potential partners, holders of licensable technology, and future investors. Running a startup is about relationships, so you should keep track of whom you have spoken to and identify who to keep updated on your progress. You should also maintain a record of public announcements to understand whether and when you have exposed any IP.
How Can We Get Started?
Now that I have you completely freaked out, let’s discuss how to get started. You don’t need fancy data systems; in fact, simple tools are often best at first. Paper and pen documents, along with a consistent filing system, have stood the test of time for recordkeeping. If you want electronic storage, scanning paper records to PDF format is simple, and the resulting files should be organized similarly to your paper files. You don’t need elaborate formats. Step-by-step checklists, outlines, and reference links are often sufficient for your business systems. Bound notebooks are a superior format for your R&D work. Still, they need maintenance to stay current (regular review and countersignature by co-workers and good indexing), and secure storage against theft or environmental damage.
Establishing a documentation system for your startup is not tricky. Start with a policy explaining what good documentation practice means to you and lists the basic rules (the what, where, when, and how of your practice). Set a regular schedule and process to make backup copies and prepare summaries. Quarterly summaries are useful in strategic planning. It’s best practice to store copies away from the originals and to have a master schedule to review, identify, and discard old or outdated records. All of these processes should have a checklist so you can maintain your recordkeeping system.
When Should We Start?
If you see your company in any of my examples, don’t hesitate to get someone working on your documentation system immediately. GDP is a process, and consistently executing small steps will get yours into shape. It will pay you back multifold as you grow, engage with partners, execute financial transactions, and implement additional systems. Waiting only lets valuable information slip away. Don’t be the team trying to recall a critical conversation or agreement months after it happened, or being unable to show prospective investors that you can handle their money.
This article has shared the why, what, how, and when of good documentation practice (GDP). I’m convinced that GDP is the basis of a sound business and existential for life science startups. If you haven’t started your system, this is a great month to do it!
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Working with life science startup companies to solve problems, strengthen systems, and build capacity is what I do. If one of your companies or clients is struggling, reach out to me to discuss how I can help your team refocus and emerge triumphant.