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Quickflow ELN

Electronic Lab Notebook

Most ELNs are digital paper: a place to type what you did. Quickflow ELN thinks with the scientist. A Digital Scientist finds what your lab already tried, proposes the design, reads results as they stream in from the instruments and names the optimum. The scientist decides, signs and hands the method straight to validation.

Quickflow ELN · EXP-0531 · Product A assay, impurity B

Signed and witnessed
  1. Objective
  2. Prior art
  3. Design
  4. Runs
  5. Reading
  6. Signed

Runs · HPLC-0513 of 13 · from CDS

RunpH°C%B/minRsTf
  • R013.0350.62.181.2
  • R022.6251.01.661.2
  • R033.4300.61.951.3
  • R043.0251.41.861.2
  • R053.0301.02.411.1
  • R062.6301.41.921.2
  • R073.4351.01.461.3
  • R083.0250.62.151.2
  • R093.4301.41.211.9
  • R102.6351.01.981.1
  • R113.0351.41.901.2
  • R122.6300.62.171.1
  • R133.4251.01.771.2

Resolution map · pH × temperatureat 1.0 %B/min

  • C18 column
  • pH below 4
  • Start near pH 3.2
  • Shallower gradient
P. Joshi· Author Signed 16:40
D. Fernandes· Witness Witnessed 17:05

People sign and witness. The Digital Scientist never does. Page v3 is locked with its audit trail.

Hand off to MVS for validation
Illustrative. It reasons, you approve.

Quickflow ELN at a glance

An electronic lab notebook for R&D that finds prior work, proposes designs and reads instrument results.

Who uses it
  • R&D scientists
  • Witnesses and R&D heads
  • QA
  • Technology transfer teams
What is included
  • Notebook issuance
  • Design of experiments
  • Structures and sequences
  • Stability studies
  • Samples, inventory and standards
  • Archive and search
Works with
  • HPLC, GC, LC-MS and more
  • Balances and pH meters
  • LIMS
  • MVS, eSheet, eDMS, eQMS
  • ERP via API
Built for
  • 21 CFR Part 11
  • EU Annex 11
  • ALCOA+
  • ICH Q14
  • GAMP 5

A notebook that thinks

Other ELNs record the experiment. Ours thinks it through with you.

An experiment has a before, a during and an after. Most electronic notebooks only help in the middle: a page to type on and a place to attach files. In Quickflow ELN a Digital Scientist works through all three, and the scientist makes every decision.

  • It starts before you do

    The Digital Scientist is at work from the moment an objective is typed, not only when there is a result to record.

  • Every claim cited

    Prior art, design choices and readings all link to the page, run or record behind them. Anyone can check the reasoning.

  • It reasons, you decide

    It searches, designs, reads and recommends. The scientist decides, and named people sign and witness. It never does.

The problem

Most ELNs are digital paper. Faster to type, no wiser.

Moving from paper to a screen changed the medium, not the work. Scientists still type results, paste chromatograms and chase a witness, and nobody can find the experiment that already failed last year.

Typical ELN · Experiment 531

Draft
Objective
Improve separation of imp. B
Earlier work
Not searched
Plan
protocol_v3_final.docx
Results
chromatogram.png · Rs typed as 2.14 The CDS says 2.41. Two digits swapped in typing, and nothing links the number to its injection.
Interpretation
Looks better. Will repeat.
Witness
Requested 11 days ago

The same experiment, recorded two ways. Illustrative.

  • Customised until it cannot move

    Years of custom fields and scripts. Every upgrade means revalidation, so the notebook stays on an old version.

  • Tools that do not talk

    The notebook, LIMS, a statistics package and spreadsheets each hold part of the story. The scientist is the integration.

  • Instruments outside the page

    HPLC, GC and LC-MS results live in the CDS. They reach the notebook by hand, one number at a time.

  • No line back to Scientific Rawdata

    A value typed from a screen has no link to the injection it came from. That gap is where data-integrity findings start.

  • Every interface a project

    Each new instrument connection needs its own validation, so labs connect a few instruments and type the rest.

  • Knowledge nobody can find

    Last year’s failed column is buried in someone else’s notebook. The next team runs the same experiment again.

How it works

5 steps. Every one recorded.

  1. Step 1Objective and prior artSystem
  2. Step 2Design proposedSystem
  3. Step 3Data from instrumentsSystem
  4. Step 4Scientist decidesHuman decision
  5. Step 5Signed and witnessedHuman decision

Before you start

Your lab has probably tried this before. Now you will know.

Type an objective and the Digital Scientist searches every notebook you can open, across sites and years. It tells you what was tried, what worked and what failed, and links each point to the page it came from. Most notebooks start with a blank page. This one starts with what your lab already knows.

Pick an objective

Separate impurity B from the main peak in the Product A assay

Reading 0 pages…

What worked

What failed

Still open

Illustrative data.

  • Only what you may open

    The search respects notebook permissions. A scientist sees citations from pages they are allowed to read, and nothing else.

  • Failures count

    Negative results are indexed as carefully as good ones. A failed column is often the most useful page in the lab.

  • Every page adds to it

    Each signed experiment becomes prior art for the next objective, at every site.

It designs the experiment

A design with a reason for every run

From the objective and the prior art, the Digital Scientist proposes the factors, their ranges and the design, and explains each choice. The scientist edits the plan and approves it before the first injection. It is the enhanced approach of ICH Q14, recorded as the work happens.

Design space · EXP-0531

13 runs

Each dot is one run. The green dot is the centre point.

Digital Scientist · Recommended. Thirteen runs at the middle of each edge plus the centre. It fits curvature and every two-factor interaction, and avoids the corners where all three factors sit at their limits at once.

Factors, and why each range

  • Mobile phase pHImpurity B tails above pH 42.6 – 3.4EXP-0488
  • Column temperatureBest result so far at 35 °C25 – 35 °CEXP-0455
  • Gradient slopePeaks merged at 2 %B/min0.6 – 1.4 %B/minEXP-0503

Held fixed and measured

  • C18 column (C8 failed, EXP-0412)
  • Resolution ≥ 2.0
  • Tailing ≤ 1.5
  • Run time ≤ 20 min
The scientist can change any factor, range or design first.

Data arrives, never pasted

Every number on the page knows where it came from

Results come into the page from the CDS, balances and pH meters as they are acquired, and calculations run as the values land. Pick any number and follow it back to the Scientific Rawdata, which is what ALCOA+ asks of every record.

  • CDSHPLC-05
  • BalanceBAL-03
  • pH meterPH-02

EXP-0531 · preparation and results

Live

Pick a value to trace it. Illustrative data.

Where it came from

2.41 R05 · resolution, impurity B

Instrument
HPLC-05 via the CDS
Record
Sequence SEQ-2291 · injection 05
Captured
13:21:09
Check
Within design target, Rs ≥ 2.0

ALCOA+

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete
  • Consistent
  • Enduring
  • Available
  • No screenshots
  • No retyping
  • Calculations run as data lands
  • Out-of-range values flagged on arrival
  • Audit trail from capture to report

It reads the results

Results read as they land, not the week after

As runs complete, the Digital Scientist fits the model, checks each result against its neighbours and says what the data means. It finds the run that does not belong and works out why, then recommends the next run or the optimum. The scientist decides.

Resolution, impurity B · 13 runs

R02 · 1.66R05 · 2.41 · optimumR07 · 1.46R10 · 1.98R13 · 1.77

Model fitted from all 13 runs, shown one slope at a time. Illustrative data.

Best Rs

2.42

Run time

18 min

Runs here

5

Digital Scientist: Recommended. Resolution sits well above 2.0 at the optimum, the run fits the 20-minute target, and this slope gives the widest region where resolution holds.

Against the targets

  • Resolution ≥ 2.0 at the best point: 2.42
  • Tailing ≤ 1.5 in every run at this slope
  • Run time ≤ 20 min: 18 min

Recommendation

pH 3.0, 30 °C, 1.0 %B/min. Resolution holds above 2.0 from 28 to 32 °C, a candidate operable region for the method.

P. Joshi decides

The Digital Scientist recommends. Only the scientist can decide.

  • Anomalies, with a cause

    A result that does not fit its neighbours is flagged, and the instrument log, column history and sample record are checked for a reason.

  • Against the hypothesis

    Each result is read against what the experiment set out to show, in plain words: supported, not supported, or not yet clear.

  • The next run

    When the answer is not yet clear, it proposes the run that would settle it, for the scientist to approve.

  • Optimum and operable region

    The best conditions and the region where the method still meets its targets: the knowledge ICH Q14 asks you to carry forward.

  • Written back as prior art

    Once signed, the findings, including what failed, are ready to be cited by the next team that asks.

Every suggestion, decision and signature is in the audit trail. See the Digital Scientist Trust Charter.

From idea to routine

One thread from idea to SOP. Nothing retyped.

In most labs a new method is copied by hand three times: from the notebook into a validation protocol, into a calculation sheet and into an SOP. Each copy is a chance to get it wrong. In Quickflow the method moves on as data, and each stage is signed by the people who own it.

Step 1 · Idea · Quickflow ELN

Carries over: A stability-indicating assay for Product A: the question, its owner and its priority.

Who signs

The R&D lead approves the idea and opens the project.

IDEA-0107

Notebook, then a Word protocol, then a spreadsheet, then an SOP, each typed again from the last.

The SOP’s 28 to 32 °C range traces back to the runs in EXP-0531 that proved it.

Everything a lab notebook needs

Sixteen modules, one notebook

Ideas and projects, the science, lab operations and long-term records, on one platform with one audit trail. The Digital Scientist works in every module.

  • Ideas

    Capture, discuss and prioritise ideas, then turn the ones that matter into projects.

    Finds related ideas and earlier work before anyone starts.

  • Projects

    Milestones, people and instruments planned, with every experiment linked to its project.

    Flags experiments holding up a milestone.

  • Templates and protocols

    Approved experiment templates for each technique, and protocols under version control.

    Drafts a protocol from the objective, for the scientist to edit.

  • Notebook issuance

    Notebooks and pages issued to named scientists, numbered and controlled like the paper ones.

    Tracks pages waiting for a signature or a witness.

In EXP-0531: IDEA-0107 became project PRJ-A-07, and EXP-0531 started from the approved HPLC development template.

Integrations

Instruments in, enterprise systems out

The notebook sits between the instruments that make the data and the systems that act on it. Values arrive with their audit trail from the moment of capture, and results move on without a second copy.

Instruments in

Quickflow ELN

From HPLC and UPLC

Peak areas, resolution, tailing and system suitability through the CDS, linked to each injection.

Enterprise systems

  • REST APIs
  • Instrument file capture
  • Database connections
  • Webhooks
  • Data exports for analytics

Already on Quickflow? Quickflow eQMS, Quickflow eDMS, Quickflow MVS and Quickflow eSheet connect out of the box.

A record you can defend

Fit to defend a patent and an inspection

An experiment page is evidence. Entries are time-stamped as they are made, pages are versioned, a correction keeps the original and its reason, and a named author signs and a named witness countersigns. The Digital Scientist’s suggestions are recorded too.

EXP-0531 · audit trail

Pick an entry. Illustrative.

What a reviewer sees · 09:12

Page opened in notebook NB-2026-044

By
P. Joshi
Notebook
NB-2026-044, issued to P. Joshi by QA on 2 March
Page
EXP-0531, numbered, cannot be deleted
Time
Server time, with time zone
Version
v1
The Digital Scientist’s suggestions are recorded. It never signs or witnesses.
  • 21 CFR

    Part 11

    Secure, time-stamped audit trails, electronic signatures linked to their records with a stated meaning, and controlled access.

  • EU GMP

    Annex 11

    Validated computerised systems, data integrity controls and change control for the system itself.

  • MHRA · FDA · WHO

    ALCOA+

    Attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available.

  • ICH

    Q14

    Analytical procedure development, including the enhanced approach: knowledge, risk and ranges recorded as they are established.

  • ICH

    Q2(R2)

    Validation of analytical procedures, run in Quickflow MVS with the development evidence carried over.

  • ISPE

    GAMP 5

    A risk-based approach to validating the system, with supplier documentation to support yours.

The controls are part of the application. Your validation confirms them for your intended use. How we prove it

Wherever an experiment has to stand as a record

  • Pharmaceutical R&D

    Formulation, analytical development and technology transfer, on one record.

  • Biotechnology

    Cell line, upstream and downstream experiments, searchable across teams.

  • CROs

    Each sponsor’s studies in their own space, ready to hand over.

  • CDMOs

    Client work kept apart, with shared methods and instruments linked.

  • API manufacturers

    Route scouting and process chemistry, with yields and conditions recorded as they happen.

  • Medical devices

    Material, extractables and test method development under design control.

Questions

Frequently asked

What R&D heads, scientists, QA and IT teams usually ask first.

  • What is Quickflow ELN, and how is it different?

    It is the electronic lab notebook on the Quickflow platform, covering ideas, projects, experiments, lab operations, stability, structures and sequences, technology transfer and long-term records. Most notebooks store what the scientist types. In Quickflow a Digital Scientist also works in the notebook: it finds your lab’s prior art, proposes the design, reads results as they arrive and recommends what to do next.

  • Does the Digital Scientist make decisions or sign pages?

    No. It searches, designs, reads data and recommends, and it shows its reasoning with citations. The scientist decides what to run and what the results mean, and named people sign and witness every page. Its suggestions are recorded in the audit trail and labelled as suggestions.

  • Where does the prior art come from?

    From the notebooks in your own Quickflow ELN, across sites and years, including experiments that failed. The search respects notebook permissions, so a scientist only sees citations from pages they are allowed to open. Historical records brought across from an earlier system can be included.

  • Which instruments connect?

    HPLC, UPLC, LC-MS, GC and GC-MS through the CDS, and ICP-MS, ICP-OES, UV-Vis, FTIR, balances and pH meters. Values arrive on the page linked to their raw record, so nobody types or pastes a result.

  • Do we still need a separate statistics or DoE package?

    For most development work, no. Screening and response-surface designs, regression, ANOVA, trends and capability run inside the page, and the Digital Scientist explains the results in plain words. Results can still be exported if your statisticians prefer their own tools.

  • How does a method move to validation and routine use?

    The developed method, its operable ranges and the development evidence pass to Quickflow MVS for ICH Q2(R2) validation. The validated calculations become an eSheet template, and the operating conditions go into the SOP in the eDMS. Nothing is retyped, and each stage is signed by its owner.

  • Does it connect to our LIMS, QMS and DMS?

    Yes. LIMS supplies samples and specifications and receives results when a method goes routine. Quality events can be raised in the eQMS from a page, and SOPs and protocols are cited by version from the eDMS. Quickflow eQMS, eDMS, MVS and eSheet connect out of the box; ERP and other systems connect through APIs.

  • Does it meet 21 CFR Part 11 and EU Annex 11?

    It provides the controls both expect: a secure, time-stamped audit trail, electronic signatures linked to their records with a stated meaning, versioned pages, controlled notebook issuance, role-based access and validation documentation. Your validation confirms them for your intended use.

Full overview: A notebook that thinks with the scientist.

Quickflow ELN is the electronic lab notebook on the Quickflow platform. It covers ideas and projects, experiment templates and protocols, design of experiments and statistics, structures and sequences, stability studies, instruments, inventory, samples and reference standards, technology transfer, collaboration across sites and long-term archive and search, on one platform with one audit trail.

Most electronic notebooks only help while results are being recorded. Quickflow works before, during and after the experiment. When a scientist states an objective, a Digital Scientist searches every notebook they are allowed to open and summarises what was tried, what worked and what failed, with each point linked to the page it came from. From that prior art it proposes the factors, ranges and design, and explains each choice. The scientist edits and approves the plan before the first run.

Results reach the page from the CDS, balances and pH meters as they are acquired, so nothing is typed or pasted and every value links back to its raw record. Calculations run as the data lands. The Digital Scientist reads each result against its neighbours and the hypothesis, flags a run that does not belong and looks for the reason in the instrument and column history, then recommends the next run or the optimum and the region where the method still meets its targets. The scientist decides.

Every page is a record fit to defend a patent and an inspection: entries are time-stamped as they are made, pages are versioned, corrections keep the original and a reason, notebooks are issued to named scientists, and a named author signs and a named witness countersigns. The Digital Scientist’s suggestions are recorded and labelled, and it never signs or witnesses. The controls support 21 CFR Part 11, EU Annex 11 and ALCOA+, and development follows the enhanced approach described in ICH Q14.

A developed method does not have to be copied into the next system. It moves as data into Quickflow MVS for ICH Q2(R2) validation, into an eSheet template for routine calculation and into its SOP in the eDMS, with each stage signed by the people who own it. Quickflow ELN also connects to LIMS, eQMS and ERP, and to HPLC, UPLC, LC-MS, GC, GC-MS, ICP-MS, ICP-OES, UV-Vis, FTIR, balances and pH meters.

See Quickflow ELN on your own process.

Tell us how this runs in your organisation today and we will walk through the application against it, with your QA and IT teams in the room.