A signature is not competence.
A technician reads a forty-page SOP and signs that they understood it. That signature is the only evidence anyone holds.
Cell & gene therapy manufacturing GMP
Your SOPs already say what to do. Operis makes sure it happens.
Operis turns your standard operating procedures into step-by-step interactive training, checks every response against the procedure's own rules, and gives QA a record of who can actually do the work.
Read-and-understand is not evidence
Document control
Sheet 01
- Document
- Operis platform overview
- Doc no.
- DOC-LP-001
- Revision
- A
- Scope
- Cell & gene therapy · GMP manufacturing
- Status
- Pre-pilot · in development
- Issued for
- Pilot program — Maryland / Mid-Atlantic corridor
- Name
- Operis — Latin, genitive of opus: "of the work."
Stage
§ 03 · The problem
DOC-LP-001 / REV A
The most controlled process in medicine, taught with a PDF.
Cell and gene therapy manufacturing runs on some of the most detailed procedures in industry. The training for them is still a document and a shoulder to look over.
Shadowing doesn't scale.
Every new hire spends weeks consuming an experienced operator's time — and inherits whatever that particular operator happens to do.
The cost of a miss is a batch.
A missed hold time, steps taken out of order, a broken aseptic technique. In autologous therapy a lost batch can be a lost patient dose.
§ 04 · The engine
Clause set 4.1 — 4.6
How a procedure becomes training
The engine decomposes an SOP into atomic steps, then rebuilds it as a sequence of checkpoints. Below: one clause of a wash-and-concentration procedure, and the same clause rebuilt as an Operis checkpoint.
SOP-2140 · Wash & concentration
Rev C · p.12/40
7.3 Wash and concentration
- 7.3.1Verify that the lot number and expiry of the wash buffer recorded on the batch record match the label applied to the bag. Record the lot number in Section 4 of the batch record prior to proceeding to 7.3.2.
- 7.3.2Transfer the product bag to the processing set. Confirm all clamps are in the positions specified in Table 7-2 before the wash cycle is initiated. Do not proceed if any clamp position cannot be confirmed visually.
- 7.3.3Initiate the wash cycle using the parameters listed in Table 7-2. Parameters shall not be altered without an approved deviation raised in advance of execution.
- 7.3.4On completion of the wash cycle the concentrated product shall be held at 2–8 °C for not more than 30 minutes prior to formulation. Where the hold time is exceeded, stop the process and notify the shift supervisor before any further step is taken. Hold time · NMT 30 min
- 7.3.5Formulate to the target volume specified in the batch record. Verify volume against the formulation worksheet before the product is transferred to fill.
| Parameter | Setpoint | Tolerance |
|---|---|---|
| Spin | 500 × g | ± 25 × g |
| Duration | 10 min | ± 30 s |
| Temperature | 2–8 °C | — |
| Hold to formulation | NMT 30 min | none |
Operis checkpoint
CP-2140-07.3.4
Instruction
The wash cycle has completed. The concentrated product is at 2–8 °C, awaiting formulation. How long may it be held before formulation must begin?
Response
Validation rule
source SOP-2140 REV C · CLAUSE 7.3.4
assert hold ≤ 30 min @ 2–8 °C
if response ≠ 30 min → HOLD
then return to clause · re-attempt required
block advance to 7.3.5 until pass
Audit line
2026-04-02T14:07:31Z · TECH-0148 · SOP-2140 REV C · CLAUSE 7.3.4 · ATTEMPT 2 · CORRECTED · PASS
Facsimile — illustrative example. Not a real procedure or customer record.
Fig. 4-1
-
4.1
Upload the SOP.
PDF or Word, exactly as it is version-controlled today. Nothing gets rewritten into a proprietary format.
-
4.2
Parse into atomic steps.
The procedure is decomposed into discrete actions, each carrying its own parameters — timing, sequence, materials, safety constraints.
-
4.3
Guide.
Each step becomes a checkpoint: the instruction, in context, with supporting video where watching beats reading.
-
4.4
Test.
The technician confirms the action or selects the correct procedure. Not a quiz bolted onto the end — a decision at every step.
-
4.5
Validate.
The response is checked against the rules the SOP itself defines. Was the hold time right. Was the sequence right. Was the constraint respected.
-
4.6
Correct before advancing.
A wrong answer is fixed at the step where the misunderstanding actually lives, before it hardens into habit.
Every step is a checkpoint. Nothing is assumed.
§ 05 · Platform
Capabilities
What you get around the training
Competency scoring Per technician · per SOP · per step
You see not only who passed, but which step the whole floor keeps failing.
Manager dashboard Floor view
Training status across the floor, built for manufacturing directors and training managers rather than for HR.
Audit logging Timestamped
Every attempt, response, correction and completion. Designed for the inspection, not bolted on after it.
Version-aware training Regenerates on revision
Revise an SOP and the training regenerates with it. The record still shows who was trained against which version.
Supporting video layer Secondary
Instructional clips attached to the steps that need them. A layer on the procedure, not the product.
Your documents stay yours No shared models
SOPs are processed to build your training. They are not used to train shared models.
§ 06 · Who it's for
Roles on the floor
Three people hold this problem
Onboarding without lending out your best operator.
Shorten the ramp for new technicians while your experienced staff stay on the floor doing the work they were hired for.
Evidence of competence, not a signature on a form.
What each technician did, on which SOP version, and where they were corrected — held as a record you can produce.
Find where the curriculum fails before the batch does.
Step-level results show which clause the floor keeps missing, so the fix goes into the training rather than into a deviation.
§ 07 · The record
Attributable · contemporaneous · complete
Built for the room it has to survive
Every interaction is logged: who, what, which SOP version, when. The record is designed to be attributable, contemporaneous and complete. Role-based access separates trainee, trainer and QA. Records export.
Trainee
Trainer
QA
Export
Note · stated plainly
Formal computer-system validation is in scope for the pilot. It is not claimed ahead of it.
Record specimen
One entry
WhoTECH-0148 · role TRAINEE
WhatCP-2140-07.3.4 · hold time
ResponseAttempt 1 FAIL → corrected → attempt 2 PASS
AgainstSOP-2140 REV C
When2026-04-02T14:07:31Z
Signed byTRAINER-014 · countersigned QA-003
ExportCSV · PDF · to your LMS of record
§ 08 · Pilot program
Protocol 8.1 — 8.4
What a pilot looks like
-
8.1
You bring one to three SOPs — ideally the ones that generate the most retraining.
-
8.2
We build the interactive training against them.
-
8.3
You run a cohort through it alongside your current process.
-
8.4
We measure together. No numbers are claimed in advance — these are what the pilot is built to find out.
(a)Time to onboard.(b)First-pass execution.(c)Deviations attributable to training.
Availability
Open now to cell and gene therapy manufacturers in the Maryland and Mid-Atlantic corridor. First module back within two weeks of receiving the documents.
§ 09 · Queries
Answered as asked
Questions we get first
Q
Does this replace our LMS?
A
No. It does the part an LMS was never built for — step-level execution and validation. Completion records export to whatever you use.
Q
Do we have to rewrite our SOPs?
A
No. They go in as written.
Q
What happens when an SOP is revised?
A
The new version is re-parsed and the training regenerates. Records still show who trained against which version.
Q
Is our SOP content used to train models?
A
No. Your procedures are processed to build your training and nothing else.
Q
How fast can a pilot start?
A
Documents in, first interactive module back within two weeks.
§ 10 · Request
Page 09 of 09
Bring us your worst SOP.
The one that generates the most retraining, the most questions, the most deviations. That is the one worth turning into a checkpoint sequence first.