Biotech briefing · 30 minutes
The Part 11 & IP Gap Review
A 30-minute diagnostic session for biotech operations, IT, and QA leaders. We map where your compound and clinical data actually lives, then measure your external exchange and signature workflow against the Part 11 record controls. You leave with a one-page gap map you can take into submission prep or a partner audit.
No demo. No follow-up sequence unless you ask. Run by MnemoShare product and solutions architects.
What this is — and isn't
Most biotech teams have their crown-jewel data locked down where they expect it: the ELN, the LIMS, the eTMF. Then there is the other copy — in a mailbox, a SharePoint folder, somebody's OneDrive — because that is where it had to go to reach a CRO at 6pm. Nobody decided that. It is just where the work happened. This session finds that second copy — and then asks, separately, what 21 CFR Part 11 would require you to produce for the records that fall under it.
We are direct about the limits of what any vendor can do here, because your QA function will be. No software is "Part 11 compliant" — compliance is a property of your validated process, not a product you buy. MnemoShare maps to the Part 11 technical controls and produces the evidence; your validated process owns the certification. Any vendor who tells you otherwise is worth a second look. We are as direct about scope: Part 11 governs electronic records and signatures, not where a file is hosted — so we label which half of this session is regulatory and which is simply about protecting your IP.
It is not a demo. We won't show you MnemoShare during the session unless your gap map surfaces something that maps to what we do — and even then, only if you ask. The map is useful whether or not you ever work with us, and it is written to hold up against whatever you are running today.
The four questions we work through
The first two questions are about your IP. The last two are about what Part 11 asks you to produce. We run them together because the answers overlap more than most teams expect — but they are different questions, and we don't dress the first two up as regulatory ones.
The second copy
Which files containing compound, formulation, or clinical data currently sit outside your systems of record — in mailboxes, SharePoint, OneDrive, or shared drives? Could you produce that list today, or is it mostly trust? This one is an IP question, not a regulatory one: Part 11 has nothing to say about where a file is hosted.
The external hop
How many CROs, CDMOs, and sites do you exchange data with, and through how many different mechanisms? When data comes back from a partner, does their audit trail come to you, or do you have to request it? This is where the regulation starts to bite: §11.30 covers records moving through environments you don't control, and asks you to hold authenticity, integrity and confidentiality from creation through receipt.
Evidence you can produce
If an inspector or a partner auditor asked today, what could you show for who accessed a given record and whether it has been altered since — and how long would assembling that take? This is §11.10(d) and §11.10(e) in practice.
Signature and identity
Where are electronic signatures applied in your workflow, and are they cryptographically bound to a verified individual or captured as a typed name? Worth confirming which tier of your current e-signature contract actually includes Part 11 — at the major vendors it sits behind an enterprise agreement. This is §11.50, §11.70, and §11.300.
The three outcomes
Across the four answers, biotech teams usually land in one of three places. All three are useful; only one of them is a project.
You're further along than you thought
The systems of record are tight and the external exchange is already governed. You leave with a map that documents it — useful evidence in its own right for a partner audit or an investor's diligence questionnaire.
A sequencing problem
The exposure work and the Part 11 work turn out to be the same work. Teams that treat them as two projects buy the controls twice — once to close the exposure, again when submission prep starts. Knowing that early is usually worth more than the map.
A gap with a date on it
There is a real gap and a submission or partner audit on the calendar. The map becomes a scoped list with a sequence, and you can decide honestly whether it is a this-quarter problem or a next-one.
What you leave with
The artifact is yours to use regardless of whether you ever work with us.
- A one-page gap map in two halves: where your regulated data and IP actually sit, and how your external exchange and signature workflow measure against the Part 11 record controls (§11.30, §11.10(d) and (e), §11.50/§11.70, §11.300).
- An honest separation of which gaps are a tooling problem and which are a process problem — the second kind no vendor can sell you out of.
- A clear answer to the sequencing question: whether your exposure work and your Part 11 work are one project or two.
- Language you can reuse with a partner auditor or an investor asking how you handle sensitive data externally.
Who runs it
Run by MnemoShare product and solutions architects, with engineering depth brought in when architectural questions surface. We map to the Part 11 technical controls and produce the evidence; we do not perform your validation, and we do not hold certifications on your behalf. If your gap turns out to be a validation-process question rather than a tooling one, we will tell you so and point you at the right kind of help.
The Part 11 & IP Gap Review
No demo. No follow-up sequence unless you ask. Run by MnemoShare product and solutions architects.