Documentation That Holds Up: Six Principles for Lean Biotech Teams

At a small biotech, documentation tends to be somebody's second job. It sits with the Clinical Operations lead who absorbed it,or the one Quality person who has created SOPs before at a larger organization but not from scratch at a small one. If you're responsible for the procedures, the source documents, and the record of decisions your team has made, this is for you. 

Your documentation is what your process looks like from the outside. An inspector or compliance reviewer assesses the record, not the behavior, and where the two differ, the record is what stands. 

That matters most for decisions a lean team has to make quickly, often with incomplete information and few people to consult. Anthea Dransfield, Diligent's Head of Quality, has watched those decisions get tested at inspection, where the inspector wants to see a written record: what the situation was, how it was handled, and who was part of the discussion. An inspector doesn't have to agree with what was decided to accept it. If the reasoning was logical and the right people were involved, they may accept an approach they wouldn't have chosen themselves. Without that record, there's nothing to evaluate. The five principles below help guide a comprehensive and defensible documentation process.

1. Procedures should describe what your team does in practice

A standard operating procedure (SOP) that works reflects exactly what the team does, no more and no less. When you write a procedure that does not align precisely with how people execute the process, in Anthea's words, you set yourself up for failure. 

Misalignment between an SOP and how the process actually runs does more than create a paperwork problem. As Anthea puts it, the process will not happen consistently in the way it should, and two people reading the same imprecise procedure will fill its gaps differently. The result is a process that varies depending on who is running it. 

This is also why procedures written without the people who execute them tend not to hold. All levels of the team need to be involved in putting the SOPs together, not just whoever owns the document, in Anthea's view. The person doing the task daily knows the step that is out of order, the check that happens earlier than the procedure says, and the part everyone works around.

2. Usability is the standard, not length 

An accurate procedure can still fail if it wasn't written with usability in mind. Anthea has seen both ends of the spectrum: SOPs running past eighty pages that end up contradicting themselves within the same document. SOPs so brief they don't give people enough information to do the job consistently. Neither length is doing what an SOP is supposed to do, which is to enable the person executing it to get it right. 

On a recent consulting engagement, a team asked whether procedural detail could move into an SOP's scope and purpose section, so people would only need to read the beginning rather than the whole document. Anthea's answer was no: scope and purpose are not where procedural steps belong, and if people won't read the full SOP, that indicates that the document is difficult to use. 

The standard is not length in either direction. It's whether someone can follow the full procedure and do the job correctly without needing anything else. 

3. Confirm the Site's process before your protocol assumes one 

Anthea has seen two Sponsors define the same procedure differently: one wants vital signs taken supine first, then standing; another wants the reverse, for a different reason. Neither is wrong, but if a Site's standard process doesn't match what the Sponsor's protocol assumes, the mismatch surfaces in the data. 

The Site isn't failing to follow instructions. A Sponsor wrote a protocol around a process that wasn't the Site's, because nobody confirmed what the Site's process was before the protocol was finalized. Sponsors, in Anthea's experience, don't always think to check, which is what sets the Site up to fail. 

Qualification, done before the protocol is locked, is where these discrepancies get caught. Getting feasibility information from a Site, understanding their standard process, capabilities, capacity, are what enable effective planning conversations and prevent data issues later on. 

4. Update the procedure when the process changes, not just on the review date 

A review cycle of two to three years is common for SOPs, in Anthea's experience, and holds only if nothing changes in the interim. On a recent consulting engagement, Anthea saw a team whose process had adapted to meet a new regulatory expectation, but the documentation was never updated to match. When the procedure was reviewed for compliance with current regulations, it showed no sign of the team's change. 

The change itself is what should trigger an update, not the calendar. For a lean team where processes shift quickly, that argues for a cadence closer to annual than two to three years. 

The same applies to source documents, just on a much shorter clock. Anthea reviews them within days of collection, because the longer a gap sits, the harder it becomes to reconstruct what happened when the time comes for explanation. 

5. Document decisions, not just procedures

"If it's not written down, it never happened." Anthea holds decisions made on the spot to that same standard, not just SOPs. These are typically made by just the Operations lead and whoever is covering Quality, with a principal investigator brought in for patient safety and data management for data integrity. Those discussions happen verbally in the moment, but they still need a record afterward: who was involved, what was decided, and why. 

That record can be written after the fact, as long as it's captured while the details are still fresh enough to address accurately: what happened, how it was handled in the moment, and how the approach changed as more information came in. Anthea calls this a "lessons learned" approach. Sharing it with the team means the next person facing something similar starts from the adapted approach, rather than making the same decision over again.

6. Proximity to the work matters more than who holds the pen 

An outside consultant can produce technically sound SOPs that the team still doesn't follow, because the person writing them isn't the person who has to live and breathe them. Alternatively, a consultant embedded with the team, who understands the why behind a procedure and not just what it says to do, can be highly effective. 
When Anthea joined a specialty CRO, she spent her first week on the operations floor, watching the work before writing anything about it. She kept an open door afterward, so the team could bring her questions or issues directly rather than waiting for a scheduled review. That's the standard worth applying to anyone writing your procedures, internal or external: they need enough contact with how the work happens to write something people will use. 
 
For lean teams weighing outside support against building it internally, the same test applies. A consultant who writes procedures without first understanding how the work actually happens has no way of knowing whether the team can follow them. Getting that groundwork right up front is what makes the difference, not fixing it after the fact. 
 

If your team is building or assessing your procedures in light of evolving regulations, Diligent's Quality experts work closely with companies of all sizes to conduct gap assessments and develop SOPs that hold up during inspections. Learn more about our ICH E6(R3) Consulting services and how you can strengthen your compliance position.