Assay and related substances
Connected workflowMethod development reportDevelopment rationale and records
Validation protocolStudy plan and acceptance criteria
Validation reportExecution results and conclusions
Regulated document automation
Regulated documents, drafted from your data
SmartX Protocols turns the records your teams already produce into structured, review-ready protocols, validation reports and risk assessments, using your approved templates and keeping qualified scientists in control.
Nothing invented. Uncertainty stays visible.
InputSource records
ControlScientist review
OutputReview-ready draft
The documentation burden
Scientists should be doing science, not spending days drafting documents
The work goes far beyond typing. Teams repeatedly transfer values, rebuild document structure and reconcile changes across records.
- Manual transfer creates review workValues move between records, protocols and reports one field at a time.
- Authoring varies by personStructure, vocabulary and formatting can drift between otherwise similar documents.
- Source checks take timeReviewers need a clear path from each proposed value back to the record that supports it.
2–7working days may be spent on a protocol or report, depending on document scope and complexity.
The SmartX trust model
Built around one rule: no silent wrong answers
SmartX makes source, uncertainty and human decisions visible throughout the drafting workflow.
Gaps remain visible
If required information cannot be found in approved source records, SmartX flags it for review instead of filling the gap with a plausible value.
Values remain linked to their source
Reviewers can see where extracted information came from and verify it against the underlying record.
Machine-read information requires confirmation
A qualified person reviews and corrects proposed information before it becomes part of the final draft.
Scientists retain control
SmartX assists with drafting and structure. Qualified personnel remain responsible for scientific decisions and approval.
Output follows the approved template
Document structure, sections, numbering, tables, headers and terminology can follow the customer’s established format.
The system stops when it cannot proceed confidently
Uncertainty becomes a review task, not a hidden assumption inside a polished document.
How SmartX works
From your records to a review-ready document
The workflow separates machine drafting from scientific judgment. SmartX organizes the document while your team confirms what the document says.
Your records
Methods, development data, notebook records, instrument exports and supporting documents.
SmartX drafting
Relevant information is extracted, structured and placed into the required document.
Controlled review
Your scientist confirms, corrects or rejects proposed information before finalization.
Standardized draft
The document follows your approved template, terminology and formatting conventions.
SmartX prepares the draft. Your qualified personnel review and approve it.Source records → review → approved template output
Capacity returned to the laboratory
Less time drafting. More time on science.
2,576illustrative hours returned across a representative annual document mix.
| Document | Manual today | With SmartX | Hours returned | Faster by |
|---|---|---|---|---|
| Nitrosamine risk assessment | 140 hours | 24 hours | 116 hours | 5.8× |
| Validation protocol | 40 hours | 2 hours | 38 hours | 20× |
| Validation report | 40 hours | 8 hours | 32 hours | 5× |
| Method development report | 56 hours | 8 hours | 48 hours | 7× |
Representative planning estimates, not guaranteed outcomes. Performance should be measured on each customer’s documents during evaluation. The annual example assumes 20 validation protocols, 20 validation reports, 10 method development reports and 6 nitrosamine risk assessments.
What returned time enables
Return the time to higher-value science
Automation should remove repetitive document production from the scientist’s day while preserving scientific review and accountability.
- Method development and optimization
- Out-of-specification investigations
- Technology transfer and site support
- Stability program oversight
- Documentation backlog reduction
- Training and mentoring analysts
Protocol-to-report continuity
The protocol writes part of the report
Information already reviewed and approved in the protocol can carry forward into the report, reducing re-entry and keeping both documents aligned.
- 01
Method
Analytical method and development data
- 02
Validation protocol
Planned work and approved criteria
- 03
Execution
Laboratory work under the protocol
- 04
Results
Notebook records and instrument outputs
- 05
Validation report
Drafted from the protocol and results
- No retypingReuse approved information.
- Consistency by constructionKeep protocol and report aligned.
- Faster reviewFocus attention on science and exceptions.
- One traceable chainFollow information back to its source.
Document families
Built for the documents analytical teams already produce
SmartX is designed around connected regulated document workflows rather than isolated one-off files.
Dissolution
Connected workflowMethod development reportDevelopment rationale and records
Validation protocolStudy plan and acceptance criteria
Validation reportExecution results and conclusions
- Cleaning validation documents
- Nitrosamine risk assessments
- Method transfer and related protocols
Workflow availability and configuration depend on document family, customer template and implementation scope.
Regulated industries
Purpose-built for pharma. Designed for controlled documentation.
SmartX begins with demanding pharmaceutical workflows. The same controlled drafting principles may also support other quality-governed industries where technical documents must stay consistent and traceable.
- Pharmaceuticals
- Biotechnology
- Medical devices
- CDMOs and contract laboratories
- Food and beverage
- Cosmetics and personal care
- Specialty chemicals
- Quality-governed manufacturing
Customer-controlled cloud environment
Cloud platformAzure or AWS
Identity & accessClient-approved identity / SSO
Approved source repositories
SharePointObject storageEnterprise DMS
SmartX applicationControlled extraction, drafting and review
Review-ready structured document
Enterprise deployment
Your environment. Your documents. Your control.
SmartX can operate within the customer’s approved Azure or AWS environment and connect to the identity services and document repositories agreed during implementation.
- Keep source records within the customer-approved cloud architecture.
- Connect to SharePoint, object storage or an enterprise document system based on the agreed scope.
- Separate automated drafting from qualified review and approval.
Specific connectors, access controls and integrations are defined with each customer. This diagram is intentionally high level.
Why SmartX
Built with the people who review and sign these documents
SmartX brings enterprise software engineering together with input from pharmaceutical professionals who understand how regulated protocols and reports are drafted, reviewed and approved.
The platform supports the document work. Qualified professionals remain responsible for the science.
Enterprise software perspectiveDesigned for configurable workflows and customer environments.
Pharmaceutical domain inputShaped around how technical documents are actually reviewed.
Human controlReview and approval remain explicit parts of the process.
Template alignmentOutput can follow customer-specific structures and terminology.
Request a demonstration
See a complete document drafted from source records
See how SmartX proposes information from source records, how a reviewer checks it, and what happens when information cannot be identified confidently.
Prefer email? Contact contact@smartxprotocols.com.