When navigating FDA compliance, one principle stands above many others: if it isn’t documented, it didn’t happen. This isn’t a pithy slogan — it’s a legal and regulatory reality. Proper record-keeping underlies everything from regulatory submissions to defending a product liability case.
For companies facing litigation or insurance claims, an experienced expert witness like Dr. Joshua Sharlin at Sharlin Consulting, LLC can spell the difference between a robust defense and a vulnerable one. Sharlin Consulting brings 25+ years of FDA regulatory experience, having served as an expert witness in over 50 cases, authored 22+ expert reports, and given more than 20 depositions — never once having his opinion excluded for a Daubert challenge. (Sharlin Consulting)
Why Documentation Matters — And What’s at Stake
The Stakes of Poor Documentation
Legal Risk and Exclusion of Evidence
- Without consistent, accurate documentation, parties may struggle to defend themselves in court.
- Courts sometimes exclude expert testimony that lacks documented basis, especially if opinions rely solely on cherry-picked or anecdotal data.
- Expert witnesses must not only interpret regulations — they must tie their opinions to documented facts.
Regulatory Consequences
- In FDA inspections, documented deficiencies often trigger a Form FDA 483, which records inspectional observations.
- Regulators maintain repositories (like the Compliance Management System) that store inspection reports, 483s, and other evidence of noncompliance.
- If companies fail to act on observations — or fail to document their responses — the risk of warning letters, enforcement actions, or recalls increases.
- Insurance and Business Claims
- Manufacturers sometimes try to claim business-loss insurance after operational failures. But if compliance problems weren’t documented, the insurer may deny claims. That’s where expert analysis comes in. Sharlin Consulting, for instance, has helped clients refute or support insurance-claim-related issues by dissecting regulatory and quality documentation. (Sharlin Consulting)
- In M&A or contract disputes, missing documentation can obscure deal triggers or obligations tied to regulatory milestones. An expert with regulatory insight can reconstruct or challenge assertions made by either party.
How Proper Documentation Protects You
Best Practices for Documentation
Establish a Reliable Record-Keeping System
- Use a Trial Master File (TMF) or electronic TMF (eTMF) system. These systems provide controlled access, audit trails, version control, and validation — all essential for FDA-regulated trials.
- Ensure that every critical action, decision, and process has a timestamped, traceable document (e.g., SOPs, meeting minutes, decision memos).
H3: Capture Inspection and Response Data
- When FDA issues Form 483 observations, respond with formal, documented corrective plans. FDA often requires that responses come in writing within 15 business days.
- Track how the organization addressed each observation, noting root-cause analyses, corrective action plans, and verification of completion.
Audit-Ready Documentation
- Perform internal mock inspections to test your documentation system — are 483-like observations being caught and addressed?
- Conduct periodic audits of your electronic record systems, ensuring data integrity, secure access, and validation processes.
The Role of an FDA Expert Witness: How Sharlin Consulting Helps
Expert Witness Contributions
Reconstructing the Record
A skilled FDA expert witness can reconstruct missing or fragmented documentation:
- Dr. Joshua Sharlin brings a Ph.D.-level biological science background, statistical skills, software expertise, and deep regulatory experience. (Sharlin Consulting)
- In litigation, he examines eTMFs, adverse event databases (like FAERS or MAUDE), labeling history, and submissions — identifying where documentation gaps may weaken a case. (Sharlin Consulting)
- His insights do more than point out problems: he offers expert opinions on how missing documentation could have affected safety, regulatory compliance, or business outcomes.
Providing Expert Reports and Testimony
- Sharlin Consulting has authored 22+ expert reports, offering objective, fact-based analysis of regulatory compliance. (Sharlin Consulting)
- He has testified in more than 20 depositions, using his deep regulatory experience to explain complex FDA requirements to judges and juries.
Working with Legal Teams
- He collaborates closely with attorneys to assess risk — highlighting both strengths and potential liabilities in the documentation.
- As a former FDA reviewer, he brings the insider’s perspective, helping legal teams understand how the FDA actually thinks, what it expects, and how to build a defense that aligns with regulatory practices. (Sharlin Consulting)
- Sharlin Consulting also offers compliance consulting beyond litigation: auditing sites, sponsors, CROs, clinical vendors, and software providers. (Sharlin Consulting)
Local / Regional Example: Maryland & the Mid-Atlantic
Because Sharlin Consulting, LLC is based in Maryland (serving nationwide), clients in the Mid-Atlantic region — including biotech hubs near Baltimore and the D.C. area — often tap this local expert. For instance:
- A Maryland-based medical device startup facing an FDA warning letter engaged Sharlin Consulting to audit its records and provide a regulatory remediation plan.
- In a product-liability case involving a Mid-Atlantic pharmaceutical company, Sharlin’s expert report unearthed deficiencies in labeling documentation and adverse event reporting, enabling the legal team to counter a plaintiff’s claim of insufficient warnings.
These regional engagements highlight how Sharlin Consulting leverages local presence with national expertise.
Addressing Pain Points: Common Documentation Challenges
Key Pain Points — And Expert Solutions
Incomplete or Poorly Structured Records
Pain point: Clinical sites, CROs, or vendors maintain inconsistent records.
Expert solution: Sharlin Consulting audits the Trial Master File, identifies gaps, and recommends document structures that align with FDA expectations.
Data Integrity Issues
Pain point: Data may be manipulated, lost, or unreliably stored.
Expert solution: With experience in software development and data integrity, Dr. Sharlin can examine system validation, audit trails, and change control to detect risk.
Weak Response to Inspections
Pain point: The company fails to properly respond to FDA observations.
Expert solution: Sharlin Consulting helps design response strategies, draft written replies, and document corrective actions — strengthening legal defense and regulatory follow-up.
FAQ —
What happens if a company has no documentation of its FDA inspection response?
Without documented responses, there may be regulatory exposure or liability. An FDA expert witness like Dr. Joshua Sharlin can analyze available data, reconstruct missing steps, and opine on whether the lack of documented action undermines compliance or safety.
Can I use an expert to explain why documentation was poor?
Yes. Sharlin Consulting offers expert evaluations of why eTMFs, SOPs, or other records failed, helping counsel demonstrate whether regulatory lapses were due to negligence, system design, or misunderstanding.
Is regulatory documentation only important for product liability cases?
No. Documentation is critical in multiple contexts: insurance claims, contract disputes, mergers & acquisitions, recalls, and audits. Sharlin Consulting provides auditing and consulting services for all these areas. (Sharlin Consulting)
How can Sharlin Consulting help prevent documentation issues before they lead to litigation?
Sharlin Consulting offers compliance audits, sponsor and CRO reviews, software validation, TMF structure consulting, and technical writing to build robust documentation practices proactively. (Sharlin Consulting)
Call to Action
If you’re involved in FDA-regulated work — whether preparing for litigation, responding to an FDA inspection, or auditing your regulatory systems — don’t leave your case (or your business) to chance. Reach out to Sharlin Consulting, LLC today. With over 50 expert witness cases, deep regulatory experience, and proven credibility under cross-examination, Dr. Joshua Sharlin can assess your documentation risk, help you reconstruct gaps, and position your team with confidence.
Schedule a consultation now via Sharlin Consulting’s contact page or call (410) 231-8900.
