Built for life sciences
Quickflow builds Digital Scientists
Agentic AI does the task. A Digital Scientist owns the science: a paired counterpart for every physical scientist that reads the method, designs the validation, judges the data and can defend it in an audit. It reasons. Your scientist approves and signs.
For life sciences: nine GxP applications for the lab, quality, production and IT, led by Quickflow MVS, the first Digital Scientist.
Job description · Method validation
HiringDigital Scientist
Owns the science
R. Mehta
Senior Scientist, AR&D
Does
- Reads the MOA, decides what the validation must proveProtocol v1.2 drafted
- Designs the robustness study, sets up the worksheets4 factors · 11 runs
- Captures Empower results, judges them against ICH Q2(R2)1 failure, reason given
- Compiles the report with its reasoning, fully traceableReport compiled
Never does
Sign. Your scientist reviews and e-signs every protocol and report.
Trusted by GxP organisations
Find your role
One platform, written for each team
Start with the part of the site that answers your questions.
QC and AR&D
Values come from the instrument, not the keyboard. You run the analysis and sign; it prepares everything around it.
Quality assurance
Deviations, CAPA and SOP changes that start from the evidence, with every record linked and signed.
Production and engineering
Logbooks checked as they are written, and alarms grouped and explained before they become deviations.
CSV and validation
A GAMP 5 validation package with IQ, OQ, PQ and traceability, and a named human signing every record.
IT and security
Hosting, AI models, sign-in and access, answered plainly. Accounts on every GxP system granted and removed for you, and every workstation locked down with proof.
The documentation scientist
A PhD chemist. Six jobs around the science. Scientists should do science.
- ProtocolDrafted by hand, 2 to 3 daysScientist
- Parameter tasksPlanned in a spreadsheet, chased by emailScientist
- WorksheetsBuilt and filled by handScientist
- Chromatogram dataTyped from EmpowerScientist
- CalculationsExcel, rechecked by the reviewerScientist
- ReportAssembled in Word, then reworkScientist
What a Digital Scientist produces
The Digital Scientist makes the case. Your scientist signs it.
Four artefacts, each with its provenance: what the AI generated it from, and who approved it.
- Artefact 01
Validation protocol
VAL-2026-031 · Assay by HPLC
Parameters, ICH Q2(R2)
- Specificity
- Linearity
- Accuracy
- Precision
AI drafted
from MOA-0417, template v7Human signed
R. Mehta, Head AR&D - Artefact 02
Pre-filled worksheets
Accuracy · Level 100%
Prep Weight Area Std 1 25.12 1,204,331 Std 2 25.08 1,201,876 Spl 1 50.03 2,398,102 Blue cells: analyst input. Everything else is already there.
AI drafted
from protocol, MOA and STPHuman enters
experimental values only - Artefact 03
Captured instrument data
- EmpowerAssay areas12 results
- BalanceWeights8 results
- ChromeleonRS areasqueued
0 keystrokes
No transcription, no transcription observations.
AI drafted
from Empower, with timestamp and userHuman signed
Audit trail, read-only - Artefact 04
Validation report
7. Results summary
Linearity r² 0.9996 Pass Recovery 99.6% Pass Precision RSD 0.7% Pass Every value links to its worksheet, chromatogram and protocol criterion.
AI drafted
from captured evidenceHuman signed
AR&D reviewer · QA approver
- ICH Q2(R2)
- 21 CFR Part 11
- EU Annex 11
- E-signatures
- Human in the loop
- Explainable AI
In one line
What it means for your role
Head of AR&D
Your Digital Scientist drafts the protocol, fills the lab notebook from the chromatograms and flags what fails, so your scientists spend the week on science.
QA and CSV
A Digital Scientist owns the science and can defend it in an audit: Part 11 and Annex 11 compliant, with audit trail and e-signatures. A qualified scientist approves every record.
IT and infrastructure
It sits beside your LIMS, CDS and SAP and pulls from them. It does not replace them.
The first Digital Scientist
Quickflow MVS. Method validation, end to end.
ICH Q2(R2) aligned. 21 CFR Part 11 and EU Annex 11 controls built in. Piloted on one live method in six to eight weeks.
8
steps, protocol to signed report
3
human signature gates
0
numbers keyed by hand
Protocol · VAL-2026-031 · Draft v1.2
Drafting1. Purpose
4. Validation parameters (ICH Q2(R2))
- Specificity
- Linearity
- Range
- Accuracy
- Precision
- Robustness
Drafted from
MOA-0417 rev 3
Template PT-ASSAY-HPLC v7
Sent for review
R. Mehta, Head AR&D
Validation Evidence Readiness
Where does your lab sit?
Four levels, from paper-dependent to continuously submission-ready.
Paper dependent
- Report
- More than 20 days
- Rework
- More than 30% of reports
- Audit
- Assembled when an audit is announced
- Most labs land here
Workflow digitised
- Report
- 10 to 20 days
- Rework
- 15 to 30% of reports
- Audit
- Weeks of preparation
Data integrated
- Report
- 3 to 10 days
- Rework
- Under 15% of reports
- Audit
- Days of preparation
- The standard
Continuously submission-ready
- Report
- Hours
- Rework
- Under 5%
- Audit
- Zero preparation
Built on the Quickflow platform
10 applications for life sciences
The Digital Scientist runs on the same compliance-first platform that already powers calculation sheets, lab notebooks, quality, documents and access management in GxP organisations.
- Drafts the ICH Q2(R2) protocol from the MOA
- Pre-fills worksheets and captures instrument data
- Compiles an audit-ready report with full traceability
- Your scientist reviews and e-signs every step
Laboratory
- eSheet · Calculation sheetsTurns laboratory calculations into secure web-based forms with access control and fine-grained permissions. Every change is versioned and audit-trailed.
- ELN · Electronic Lab NotebookReplaces paper notebooks with structured, compliant digital records that improve collaboration and searchability.
- eLogbook · Electronic LogbookDigitises traditional logbooks for equipment usage, calibration and similar activities with secure electronic records.
Quality
- eQMS · Quality Management SystemManages change controls, deviations, CAPA, market complaints and OOS investigations with the precision inspectors expect.
- eDMS · Document Management SystemControls SOPs, STPs, protocols and other GxP documents with audit trails, version control and structured approval.
- Alarm Trending · Alarm Trending ManagementReads alarms live from instruments and building systems, groups them into events and explains the cause, so drift is caught before it becomes a deviation.
- CPV · Continued Process VerificationCollects, analyses, trends and reports process data in real time to confirm processes stay within predefined quality criteria.
IT and access
- UAM · User Access ManagementEmployee details come from HRMS, or are entered in UAM, and the requestor picks the systems. After manager review and system owner approval, Quickflow Vision grants or removes access on each selected system, with 21 CFR Part 11 audit trails.
- ECS · Endpoint Control SystemKeeps Scientific Rawdata on GxP workstations original and complete: cut, copy, paste, rename, delete and drag-and-drop are removed from protected folders, and every computer confirms live that its approved controls are in force.
Need an application that is not here? Describe it in a sentence and the platform builds, tests and documents it for your sign-off. How the platform works
Trusted Digital Scientists to save lives.
Hire a Digital Scientist for one validation.
A fixed-price pilot: one live method, one team, six to eight weeks, measured against a metric we agree up front, such as report cycle time and right-first-time rate.
Week 0
Agree the success metric
Weeks 1 to 6
One live method, one team
Throughout
Measure cycle time together
Week 8
You decide on the evidence