Dossier validation and accuracy
How Bloom checks every claim before the dossier reaches your desk.
An imprecise dossier costs time. A value that differs between two sections, a data point with no support in the source document or a field filled in by assumption becomes an exigência, and every exigência delays the registration.
This page describes how the platform handles accuracy: how each data point is extracted together with its source address, how the agents fill each section, how the result is evaluated before it counts as ready, and what the regulatory expert checks before signing. At the end, the audit kit that ships with the delivery.
Written for Regulatory Affairs and Quality Assurance teams, and for those who audit them. The PDF version (Portuguese) is the companion to our Data protection and information security document, available on request by email.
Layer 1 · Extraction: Every data point is born with an address
Every value read carries a reference to the exact point it came from, and that reference travels with it into the final dossier and the audit kit.
References at the value level
A specification range, a batch number or an expiry date keeps the file, page and passage it came from. Checking any field in the dossier leads back to the exact line in the source document.
A discrepancy becomes a recorded open item
When the same data point appears in two documents with different values, the platform records the discrepancy and points to both sources. The choice between them stays with whoever has the context to decide, and it appears in the audit kit as an open item.
Layer 2 · Drafting: Drafting by specialised agents
Each section of the dossier has its own requirements for content, format and source. A generic agent gets it wrong exactly where the detail matters, so each section is filled in by an agent given that section's rules.
Every section has its own set of rules
The agent filling in the API specification is given what Anvisa expects from that table, the required format, approved examples and a map of where that information usually sits in the CTD. The agent for the next section is given a different set.
Specialised without training on your data
Specialisation comes from instructions, examples and rules given to the agent at the time of the work. No model is fine-tuned or trained on client documents.
Mandatory citation
Every claim produced carries a reference to the passage that supports it. A sentence without a reference is treated as a defect by the next layer, which removes the agent's option to fill in what merely sounds plausible.
The agent declares what is missing
When the source does not support a field, the agent records the gap and moves on. The field reaches the expert flagged as open, with a note of what is missing. A declared gap is resolved before filing; a gap filled in by assumption shows up later as an exigência.
Examples of what changes from one section to the next| Dossier section | What the agent is given | CTD location |
|---|
| API specification | Mandatory parameters, limits, pharmacopoeial reference and the table format. | M3.2.S.4.1 |
| Analytical method validation | The parameters required by RDC 166/2017 and the summary for each validation report. | M3.2.S.4.3 |
| Batch analyses | Batches, scale, manufacturing site and result per parameter. | M3.2.P.5.4 |
| Manufacturing data | Master formula, flow chart, critical steps and equipment. | M3.2.P.3.2 · P.3.3 |
| Stability | Conditions, time points, packaging and proposed shelf life. | M3.2.P.8 |
Layer 3 · Evaluation: Automated evaluation: the evals
An eval is the systematic, repeatable assessment of the system's output against an expected result. The logic is that of a quality control test: there is a reference standard, there is an acceptance criterion, and the result is recorded.
Compared with previously approved dossiers
Real cases that went through Anvisa, with a known regulatory outcome. The most demanding reference available.
Compared with expert answer keys
Correct answers built by hand for test cases, including the hard ones and the known traps of each section.
Criteria per section
Mandatory fields present, required format respected, the source cited for every claim.
The judge took no part in drafting
Evaluation is done by a second agent, which receives the section produced, the source documents and that section's criteria, and answers objective questions. Separating who drafts from who judges is deliberate, because the same agent tends to accept its own reasoning.
Reference set and change control
The reference set is fixed and grows with every new case. When something changes in the platform, whether a model, an instruction or a rule, the whole set is reprocessed and the outputs are compared with the approved ones. If a section that used to be correct starts to diverge, the change is held until the cause is understood. No change goes into production because it looked better on a single case.
Layer 4 · Verification: Human verification before sign-off
The three previous layers exist so that the regulatory expert receives material that is already consistent and can spend their time on what takes judgement. Responsibility for what is delivered stays with a person.
Reviews section by section
Checks the content against the cited sources, with the source document one click from every claim.
Resolves what the evaluators flagged
Every recorded discrepancy reaches them with the flag and the source, without having to be hunted down.
Closes the open items
Decides what can be completed with the material available and what has to go back to your company as a question.
Approves and signs
The delivery goes out with a name, a date and a record of what was changed relative to what the agents produced. Each evaluator's opinion and the justification for every section marked not applicable are recorded too.
Controlled access
Granted on a need basis, to the smallest number of consultants assigned to the project, with scope limited to that dossier's documents. Individual credentials with a unique, random, strong password plus two-factor authentication, and a log of who accessed what, when, and what was viewed or changed.
Delivery · Audit kit: The audit kit
Alongside the dossier, your team receives the record of how it was built, so that any claim can be defended months later, by someone who took no part in the work.
Provenance map
Every claim in the dossier linked to the file, page and passage it came from. It is the document that answers, in seconds, where a questioned number came from.
Points of uncertainty
Where the source was ambiguous, where more than one reading was possible and where two documents disagreed. Each point comes with the sources involved and the reading adopted.
Items requiring confirmation
Data only your company can confirm, listed as explicit open items before filing, with a note of who usually holds the information.
Coverage and verification report
Sections completed, sections marked not applicable with their justification, and what each verification layer flagged along the way.
What it is for after delivery
The kit supports the answer to an exigência, because the evidence for every claim is located. It supports an inspection, because the path between data and source is on record. And it supports continuity, because a team that takes over the product later finds the decisions made and the reasons for them.
Want to see the audit kit for a real dossier?
We present the method to your Quality Assurance team and answer your supplier qualification questionnaire.
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