Applications · Quality
Quality Management System
A quality event should not start as a blank form. In Quickflow eQMS it is raised by the system that saw it, already linked to its records, and a Digital Scientist gathers the evidence and makes the case for the root cause. The investigator confirms it, QA signs, and effectiveness is measured from live data.
Quickflow eQMS · DEV-0412 · Column oven excursion, HPLC-07
Effectiveness check- Raised
- Evidence
- Root cause
- CAPA check
- QA sign
- 6Effectiveness
CAPA-188 · effectivenessLive
Day 34 of 90
0 excursions- Source: daily oven check, HPLC-05 and HPLC-07 logbooks
- Closure: QA signs at day 90, not before
Time shown fast-forwarded. Illustrative data.
CAPA · duplicate checkApproved · M. Desai
CAPA-188 · HPLC-05 oven sensor · openSame cause
Recommend: extend CAPA-188 to HPLC-07
CorrectiveEngineering
Replace the oven sensor on HPLC-07
PreventiveQC
Add a daily oven check to HPLC logbooks
The samples moved to HPLC-05, which CAPA-188 covers. Its interim oven check passed today, so the re-run can go ahead.
Effectiveness criterion
No oven excursion on HPLC-05 or HPLC-07 for 90 days of use
Effectiveness is watched, not diarised
Every new oven reading on HPLC-05 and HPLC-07 counts towards the criterion. An excursion resets it and alerts QA. When it has held for 90 days, QA reviews the evidence and signs closure.
- eLogbook daily checks
- CPV trend
- Closure by QA
Quickflow eQMS at a glance
Quality management software where each event is raised from its source and investigated from the evidence.
- Who uses it
- QA heads
- Investigators
- Event owners
- CDMOs and suppliers
- What is included
- Deviations and CAPA
- Change control
- OOS, OOT and lab incidents
- Market complaints
- Audits and supplier qualification
- Quality risk management
- Works with
- eLogbook
- LIMS
- eDMS
- LMS
- eBMR / MES
- ERP
- Built for
- 21 CFR Part 11
- EU Annex 11
- ICH Q9(R1) and Q10
- ISO 13485
- GAMP 5
Evidence first
Other systems give you a form. Quickflow gives you the case.
Most eQMS software is forms and routing: someone types what happened, and the record waits while people chase the facts. In Quickflow, a quality event is raised by the system that saw it, and a Digital Scientist gathers the evidence before the investigator opens it.
A form-first eQMS · new deviation
Waiting- What happened
- “Oven temp high on HPLC”, typed by the analyst
- Batch and samples
- To be confirmed
- Instrument history
- Ask engineering
- People
- Ask the lab
- Similar events
- Search the tracker
- Probable cause
- Blank
Quickflow eQMS · DEV-0412
Ready to investigate- What happened
- Batch and samples
- Instrument history
- People
- Similar events
- Probable cause
The same deviation, the moment each record opens. Illustrative.
Raised where it happened
The eLogbook, LIMS, the batch record or a complaint opens the event, with the source record attached. Nobody retypes what a system already knows.
Evidence cited, not pasted
Every finding links to the record it came from. A reviewer or an inspector can follow any statement back to its source in one click.
It reasons, you decide
The Digital Scientist makes the case. A named investigator confirms the cause and QA approves and signs. It never closes a record.
Quality events today
The deviation is logged in minutes. The facts arrive by email.
Raising a quality event is quick. Investigating it is not: the evidence lives in the logbook, LIMS, the calibration file and the training system, and someone has to go and ask for each piece.
HPLC-07’s column oven read 36.4 °C during an assay. What does the investigator have?
Email, spreadsheets, Word
7 handoffs- AnalystEmails QA: “the oven ran hot on HPLC-07”
- QAReplies: which batch, which samples?
- LabSends a photo of the logbook page
- EngineeringDigs out the calibration certificate
- QAChecks training in another system
- QASearches a spreadsheet for similar events
- InvestigatorPastes it all into a Word report
Quickflow eQMS
3 steps- 1eLogbookOpens DEV-0412, linked to the entry, instrument, samples and analyst
- 2Digital ScientistCites the evidence and proposes the probable cause
- 3InvestigatorStarts from the case and confirms the cause
Step comparison, illustrative. Not a measured result.
Gaps an inspector finds first
A deviation with no link to its CAPA, a correction with no reason, an audit trail split across three tools. Each one is a finding waiting to happen.
One event, five trackers
Deviations in one tool, CAPAs in a spreadsheet, changes in another. The same details are typed again, and due dates slip between them.
Quality seen in the rear-view mirror
Trends surface at the monthly review, after the batches are made. Nobody can see open deviations, CAPAs and OOS results in one place today.
Investigations that wait on inboxes
The facts sit in other people’s systems. While they are chased by email, the batch waits for release.
Partners on the far side of an email
CDMOs, suppliers and contract labs cannot see or add to an investigation, so it stalls at every handoff.
Every site its own process
Different forms, different risk classes, different reports. A group-wide view means rebuilding the numbers by hand.
How it works
5 steps. Every one recorded.
- Step 1Raised from the source systemSystem
- Step 2Evidence gathered and citedSystem
- Step 3Root cause confirmedHuman decision
- Step 4CAPA approved and signedHuman decision
- Step 5Effectiveness verified, closedHuman decision
The closed loop
Six steps, one record, no loose ends
Deviations, complaints, audit findings and OOS results all run the same loop. The loop only closes when the fix is shown to work, and every step is linked to the one before it.
DEV-0412
Detect
Step 1 of 6
Detect
Digital Scientist
Opens the event from the eLogbook, LIMS, the batch record, a complaint or an audit, links the source records and proposes a risk class.
Your team
The event owner accepts or changes the class.
DEV-0412DEV-0412 opened by the HPLC-07 alert. Proposed: major, possible impact on batch B-2431.
A Digital Scientist for investigations
The investigation starts from a case, not a blank form
Agentic AI would route the form faster. A Digital Scientist reads the evidence: it fills each branch of the fishbone from cited records, weighs them and says which cause is most probable and why. The investigator confirms or rejects every branch, and signs.
DEV-0412 · fishbone, filled from the evidence
Pick a branch. Illustrative.
Investigator decisions: 0 of 6Every branch needs a person’s decision before the root cause is signed.
Branch · People
Digital Scientist: Unlikely. The analyst was trained and entered the right setpoint.
Evidence
- TRN-2207K. Iyer current on the assay SOP and on HPLC-07
- LB-HPLC07-0412Setpoint entered as 30 °C, as the method states
Investigator
Summaries with sources
A plain account of any deviation, investigation or CAPA plan for the reviewer, the site head or an inspector. Every sentence cites its record.
Root cause from history
Past investigations across sites are matched to the new event, with the causes that were confirmed and the actions that worked.
Signals before events
Rising deviation rates, repeat causes and drifting trends are flagged by product, line or supplier before they become a pattern.
Change impact
A proposed change is traced to the products, processes, documents and filings it touches.
CAPA overlap
New CAPAs are compared with open ones by cause, not by title, so the same problem is fixed once.
Bottlenecks
Where records wait, and on whom, with a rerouting suggestion that the process owner approves.
Every suggestion, decision and signature is in the audit trail. See the Digital Scientist Trust Charter.
CAPA
One cause, one CAPA. Proven by data, not a date.
Before a CAPA is created, open CAPAs are checked for the same cause, so a site does not fix one sensor model three times. Once it is approved, effectiveness is measured against live data from the moment the actions are done.
Before a CAPA is created
DEV-0412, root cause confirmed: oven temperature sensor. Checking open CAPAs…
- CAPA-171Balance BAL-03 calibration drift
- CAPA-179HPLC-11 pump seal leak
- CAPA-188HPLC-05 column oven sensor
- CAPA-192Dissolution bath temperature
CAPA-188 · effectiveness
Criterion: no column oven excursion on HPLC-05 or HPLC-07 for 90 days of use. Source: daily oven checks in the eLogbook.
Day 0 of 90
WatchingEvery new logbook reading counts. Nobody waits for a review date to find out whether the fix worked.
Time shown fast-forwarded. Illustrative data.
Effectiveness
A date on a calendar
Quickflow eQMS
The check
A reminder on a date set months ago
A measurable criterion, written when the CAPA is approved
The evidence
Collected by hand when the date arrives
Read continuously from the eLogbook, LIMS or CPV
A recurrence
Found at the next review, or by an inspector
Raised the day it happens, and the CAPA reopens
- Actions with owners and due dates
- Escalation by risk and SLA
- Proof attached to each action
- Linked SOPs, training and forms updated
- Closure signed by QA
Eleven modules
Every quality process, linked record to record
Eleven modules in four groups, on one platform with one audit trail. A complaint can become a deviation, a CAPA and a change without anyone retyping it, and the trail stays intact.
Deviation
From detection to closure, with risk-based classification and every linked record in one place.
Raised from
- eLogbook
- eBMR
- LIMS
- People
Proposes the class and gathers cited evidence before triage.
CAPA
Investigation, actions and an effectiveness check that runs on live data.
Raised from
- Deviations
- Audits
- Complaints
- OOS
Checks open CAPAs for the same cause and drafts the plan.
Change control
Planned and unplanned changes to processes, equipment, materials and systems: plan, assess, implement, verify.
Raised from
- CAPA
- Projects
- Suppliers
Traces impact across SOPs, training, methods and filings.
One trail, end to end · example
- DEV-0412
- CAPA-188
- CC-0093
- SOP-QC-031 v5
Change control
Change control that knows what it touches
A change is only as safe as its impact assessment. Quickflow traces a proposed change through equipment, documents, training, methods and filings, then drafts the follow-on work so nothing is left to memory.
CC-0093 · from CAPA-188
Standardise the column oven sensor on every HPLC
- Plan
- Assess
- Implement
- Verify
What it touches
Equipment
—
SOPs
—
Training
—
Methods
—
Logbook forms
—
Regulatory filings
—
Triggered for owners to approve
- SOP-QC-031 revision drafted in the eDMS, for review
- Training assigned in the LMS, due before the SOP is effective
- Logbook form v1.1 sent to QA for approval
- Oven temperature test added to each HPLC’s OQ
- Filing assessment recorded, with the reasoning
Illustrative.
Live quality data
See quality while it is happening
Deviation trends, CAPA ageing and the risk picture update as records change, by site, product or department. The monthly review starts from what is true today, not from a spreadsheet built last week.
Quality overview · last 12 weeks
Open deviations
27
Open CAPAs
33
In effectiveness check
6
Overdue actions
3
Minor Major Critical
Under 30 days18
30–60 days9
60–90 days4
Over 90 days2
Likelihood
Illustrative data. Click any figure in the product to open the records behind it.
- OwnerDay 1
- ManagerSLA passed
- Head of QAStill open
Assigned by risk class
Escalation by risk and SLA
Deadlines follow the risk class. When one passes, the next person up is told, and every escalation is recorded.
- Deviations
- CAPA
- Complaints
- OOS · OOT
- Stability
- Batches
APQR data, already gathered
Deviations, CAPAs, complaints, OOS and OOT, stability and batch data compiled by product for the annual review, with trends.
On the floor, gowned…
Mobile on the floor
Raise a deviation, record an audit observation, attach a photo or approve a step from a phone or tablet, where the work is.
E-signatures and audit trail
Every signature is bound to its record with a stated meaning and a fresh authentication. The audit trail cannot be edited.
Workflows without code
Quality teams set forms, routing, escalation and notifications themselves, and every change to a workflow is versioned.
Many sites, one standard
Configure centrally, allow local steps where a site needs them, and see consolidated figures for the group.
Partners and systems
Investigations don’t stop at your front door
Much of the evidence for a quality event sits with a partner or in another system. CDMOs, suppliers and contract labs work in the same record with controlled access, and the systems that see events raise them directly.
Your Quickflow eQMS
You decide who sees which record, and for how long
CDMOs
Sees
Deviations and CAPAs on your products, and nothing else
Does
Investigate, attach evidence and sign their part of the record
Own login, own signature, full audit trail
Suppliers
Sees
Their own audit findings, complaints and supplier CAPAs
Does
Respond, upload certificates and close actions for your approval
Own login, own signature, full audit trail
Contract labs
Sees
OOS and OOT investigations on the samples they tested
Does
Share Phase I findings and method transfer records
Own login, own signature, full audit trail
Ready for the inspector. Hand over one record with its timeline, evidence, partner contributions and signatures, instead of a binder assembled the night before.
Connected to the systems that see quality events first
- eLogbookDeviations raised from logbook alerts with the entry attached; effectiveness read from daily checks.
- eDMSSOP revisions triggered by changes and CAPAs; controlled copies kept current.
- CPVProcess drift raised as a quality event; effectiveness measured on the trend.
- Training (LMS)Training assigned when an SOP changes; training status used as evidence.
- LIMSOOS, OOT and lab incidents opened from results, with the samples linked.
- eBMR / MESProduction deviations raised in the batch record; batches held until assessed.
- RIMSThe registration impact of a change checked before it is approved.
- Cleaning validationCleaning failures and residue results raised as quality events.
- PharmacovigilanceComplaints with a safety angle passed on as a case.
- ERPSupplier master data, batch genealogy and stock holds for recalls.
Already on Quickflow? Quickflow eLogbook, Quickflow eDMS and Quickflow CPV connect out of the box.
Regulatory compliance
Built for the standards your quality system answers to
The controls regulators look for are part of the application. Your validation confirms them for your intended use.
21 CFR
Part 11
Audit trails that cannot be edited, electronic signatures bound to their records, and controlled access.
EU GMP
Annex 11
Validated computerised systems, data integrity, and change control for the system itself.
ICH
Q9(R1)
Quality risk management: assessment, control, communication and review recorded against events, changes and suppliers.
ICH
Q10
The quality system elements it names: CAPA, change management, management review and process performance monitoring.
ISPE
GAMP 5
A risk-based validation approach, with supplier documentation to support it.
ISO
13485
The CAPA, complaint, change and supplier controls a medical device quality system relies on.
EU
MDR · IVDR
Complaint trending and records that feed post-market surveillance and vigilance reporting.
MHRA · FDA
ALCOA+
Every record attributable, contemporaneous and original, from the first entry to the archive.
Across life sciences
Pharmaceuticals
Finished dose and R&D sites, where deviations, OOS and change control run every day.
Biotechnology
Biologics processes with long investigations and many hands on the evidence.
Medical devices
Complaints, CAPA and supplier control under ISO 13485 and EU MDR or IVDR.
Cell and gene therapy
Small batches, tight timelines, and no room for an investigation that waits.
CDMOs
Each client’s events kept apart, and shared with that client under control.
API manufacturers
Multi-step plants with supplier, change and deviation records across every stage.
Questions
Frequently asked
What QA heads, investigators and IT teams usually ask first.
What is Quickflow eQMS, and how is it different?
It is the quality management application on the Quickflow platform, covering deviations, CAPA, change control, audits, complaints, suppliers, recalls, OOS, OOT, lab incidents and risk. The difference is where an event starts: it is raised by the system that saw it, and a Digital Scientist gathers cited evidence and makes the case for the root cause before the investigator opens it.
Which modules are included?
Eleven, in four groups. Core quality actions: deviation, CAPA and change control. Audit and compliance: audits, complaints, supplier qualification and recalls. Lab and trending: OOS with Phase I and Phase II, OOT and lab incidents. Risk: quality risk management under ICH Q9 and FMEA.
Does the Digital Scientist decide the root cause?
No. It gathers the evidence, fills the fishbone, weighs each branch and explains which cause is most probable and why. A named investigator confirms or rejects every branch, and QA approves the CAPA plan with an e-signature. It never signs, closes or dispositions a record.
How does it avoid duplicate CAPAs and prove effectiveness?
Before a CAPA is created, open CAPAs are compared by cause, component and failure mode, and extending an existing CAPA is recommended where it fits. Each CAPA carries a measurable effectiveness criterion that is checked against live data, such as logbook readings or CPV trends. A recurrence reopens it the same day.
Can CDMOs, suppliers and contract labs take part?
Yes. Partners get their own logins and see only the records you share with them, such as deviations on your products or their own supplier CAPAs. They add evidence and sign their part, and everything they do is in the audit trail.
Does it connect to our LIMS, ERP and MES?
Yes. LIMS can open OOS, OOT and lab incidents with the samples linked; the batch record can raise production deviations and hold batches; ERP supplies supplier data and batch genealogy. Quickflow eLogbook, eDMS and CPV connect out of the box.
Does it work across several sites?
Yes. Workflows and risk classes are configured once and shared, a site can add local steps where it needs them, and QA leadership sees consolidated dashboards for the group.
Does it meet 21 CFR Part 11 and EU Annex 11?
It provides the controls both expect: an audit trail that cannot be edited, electronic signatures bound to their records with a stated meaning, role-based access and validation documentation. Your validation confirms them for your intended use.
Full overview: Quality events that arrive with the evidence.
Quickflow eQMS is the quality management application on the Quickflow platform. It covers eleven processes in four groups: deviation, CAPA and change control; audits, complaints, supplier qualification and recalls; OOS, OOT and lab incidents; and quality risk management with FMEA. Every record sits on one platform with one audit trail, so a complaint can become a deviation, a CAPA and a change without anyone retyping it.
Most quality systems start with a form that someone fills in, then wait while people chase the facts by email. Quickflow starts where the event happened. An eLogbook alert, a LIMS result, a batch record or a complaint opens the event with the source record, the instrument, the batch, the samples and the people already linked.
A Digital Scientist then does the groundwork an investigator would otherwise do by hand. It reads calibration and maintenance history, the instrument's logbook, training records, affected results and past events, cites each finding to its record, fills the fishbone and explains which cause is most probable and why. The investigator confirms or rejects every branch, and nothing is closed or signed by the Digital Scientist.
Before a CAPA is created, open CAPAs are compared by cause, component and failure mode, so the same problem is fixed once. Each CAPA carries a measurable effectiveness criterion that is checked continuously against live data from the eLogbook, LIMS or CPV. A recurrence reopens the CAPA the day it happens; when the criterion holds, QA reviews the evidence and signs closure. Change control traces each change through equipment, SOPs, training, methods and filings, and drafts the follow-on tasks for their owners to approve.
Live dashboards show deviation trends, CAPA ageing and the risk picture by site, product or department. CDMOs, suppliers and contract labs work in the same records with controlled access. Electronic signatures, an audit trail that cannot be edited and role-based access support 21 CFR Part 11 and EU Annex 11, with the processes ICH Q9 and Q10 describe built in.
Quality
Related applications
See Quickflow eQMS 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.