Document Control for Biotech Companies: Protecting Your Most Valuable Assets

In the biotech scale-up space, your data and documentation are often the extent of your IP. That’s why you need to protect and manage them right through document control. Here’s how.

From data to documentation - making a biotech business

Scientific data brings the evidence that your novel biotech ideas are credible. Business and compliance documentation is how you organise that data to secure funding and turn your ideas into a saleable product.

But how does that process happen?

Andreas Föller’s article in the periodical Nature describes the stages of biotech growth that typically take companies from concept to product launch and beyond - with all the leaps in data and document management that entails.

As Föller points out, to be a successful company in this space, you need the tools and discipline to ‘translate research results into revenue’.

To manage these shifts, you don’t just need systems proving the provenance and integrity of your research and clinical data. You need systems that can help you organise scaling teams to deliver projects on time, make regulatory submissions, manage suppliers, coordinate board reporting, and collate your financial records all in one digital hub.

9 ways ‘next level’ document control will support the growth of your biotech company

The kinds of document control you need in place to coordinate these processes are ‘next level’. Here’s how those tools will help you from the get-go:

1. Scientific validity and reproducibility

Biotech research and development relies heavily on experimental data. Ensuring data integrity is essential for producing valid, reproducible scientific results that can withstand scrutiny and peer review. Without being able to prove the data’s provenance, approval history and validation processes - a startup's scientific claims and discoveries may be called into question.

2. Meeting GXP guidelines

Biotech startups often work in highly regulated fields like drug development. Regulatory bodies such as the FDA require strict data integrity practices in line with GXP and GMP guidelines, ensuring the safety and efficacy of new therapies. Failing to maintain data integrity through the right kind of audit trails (and FDA 21 CFR Part 11 compliant digital signatures) can lead to delays in approvals, or even rejection of products.

3. Managing quality events

Biotech companies need digital tools in place to ensure that SOPs are documented and followed. You need ways of triggering CAPAs that meet GXP requirements, ensuring both reactive handling of quality events and proactive monitoring for non-conformances. Setting up these procedures from the start and being able to scale controls as your R&D progresses is key to retaining the integrity of your process. It’s vital for compliance reporting throughout your product lifecycle.

4. Supplier quality management

It’s not just internal quality activities you need to monitor. You need ways of capturing and storing equipment calibration data from third-party specialists to prove regulatory compliance. You need a system that can help you formalise your supplier quality management, so you have ways of measuring performance and spotting problems with their output. Choosing a single digital hub where these records can be properly stored and controlled will be vital for proving GxP compliance.

5. Investor confidence

Biotech startups often rely on investor funding to support their research and development efforts. Investors need to trust that the data supporting a startup's technology or products is accurate and reliable. Strong data integrity practices help build and maintain investor confidence and take you to successful exits.

6. Intellectual property protection

Many biotech startups base their value on proprietary data and discoveries. Ensuring data integrity helps protect intellectual property by providing a clear, auditable trail of research and development activities. This can be crucial in patent applications and potential legal disputes.

7. Decision-making and strategic planning

Accurate, reliable data is essential for making informed decisions about research directions, resource allocation, and product development strategies. Traceability and accountability through documentation are everything. Poor data integrity can lead to misguided decisions and wasted resources.

8. Data protection

Many biotech startups work with sensitive data, including patient information or genetic data. Ensuring data integrity is an ethical imperative to protect the privacy and rights of individuals involved in research. Is your data managed according to the document security principles of ISO 27001?

9. Long-term value and scalability

As startups grow, the volume and complexity of their data increase. Establishing strong data integrity practices early on - through robust storage hierarchies and approval workflows - creates a foundation for scalable, reliable data management as the company expands.

But you can’t do it with Excel!

Google Docs or Excel and a shared drive won’t be enough to establish this deep-rooted approach to data integrity and document control within your company.

Choosing an eQMS (Electronic Quality Management System) can give your biotech scale-up the digital structure you need to ensure the integrity of all your data and documentation right from the start.

An eQMS will help you manage your business and prepare for regulatory scrutiny: 

• Establish access controls
• Automate workflows
• Control the development and collaborative process
• Establish SOP workflows for quality assurance
• Establish audit trails showing the decision-making process
• Establish a full change control process
• Deviation management
• Scale your document management process as paperwork grows
• Store and manage experimental data - according to ALCOA principles

But you don’t need to install a heavy-duty QMS to achieve this kind of control and build out your business idea in an organised way. While some systems will force you to use their SOP templates and manage data in particular ways, others allow you to customise your approach in ways that make sense to you at each stage of your business development.

A Lean eQMS is the digital framework you need to protect and grow the kernel of your scientific inspiration into a saleable product as you shift from early-stage start-up to thriving biotech company.