Quality and Training, Connected in One System
Manage quality events, CAPAs, audits, SOPs and training records in one connected system. Use LMS and QMS together, separately, or alongside other Flex modules.
100+
life sciences teams
3-10 wks
to go live
21 CFR Part 11
e-signatures controls
1 loop
finding → CAPA → SOP → training
A Tuesday, before vs. after
A new SOP version goes out by email with printed acknowledgment formsThe new version automatically triggers re-training, completion d with a 21 CFR Part 11-ready e-signature
Audit findings live in one spreadsheet, CAPAs in anotherFinding → CAPA → updated SOP → training: one traceable chain
QA assembles training matrices the week before an inspectionThe training matrix and SOP history stay current and can be exported at any time
Designed to Support Regulated Quality and Training Operations
Audit trails, electronic signatures, version control, role-based access and training records are included as standard, with validation documentation and inspection readiness.
"One major advantage is the ability to create specific reports ourselves. Additionally, we value that our feature requests are taken seriously by Flex Databases and added to their development roadmap. We also benefit from their customer-specific configuration service."
Ulrike Schorr-Neufing
Director Personnel & Qualification, ABX-CRO
"Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices."
Tameo Kobayashi
Chief Innovation Officer, CMIC Holdings
"I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done."
Craig Winter
CIO, Agenus Inc.
An Audit Finding Shouldn’t End up in a Spreadsheet
Flex LMS & QMS replaces the disconnected trackers, email notifications and paper acknowledgment forms with one closed loop: from an incident or audit finding to CAPA, an updated SOP and completed training with electronic signature.
Key LMS & QMS Benefits: Three Recurring Headaches, Removed
Each one reflects a real use case, not just a feature name.
Deviations, findings and incidents tracked in separate spreadsheets, CAPAs never checked for effectiveness
Quality Events & CAPA
Register any issue – deviations, incidents, near misses – and run a structured CAPA workflow from initiation and root cause analysis through implementation, observation period and effectiveness check.
Audit records scattered across folders, letters and reports written from scratch each time
Audit Management
Plan and conduct any type of audit – internal or external – through its full lifecycle, with findings linked directly to CAPAs and SOPs, and audit notification letters, plans, reports and certificates generated from your own templates.
Nobody can say on the spot who's trained on which SOP version
Training & Competence
Electronic training records for every employee, an auto-maintained training and SOP matrix, batch assignment for onboarding and study start-up — with completion confirmed by 21 CFR Part 11-ready e-signatures.
Every Part of LMS & QMS, in Plain Terms
Everything a quality and training team needs — each area validated independently and connected by default, so nothing has to be stitched together later.
Quality Events & CAPA
Register, evaluate and resolve quality events through a structured workflow, with supporting evidence linked to the record.
Deviations, observations, incidents, process issues
Severity and impact evaluation, CAPA decision based on assessment
Structured CAPA: initiation → investigation → root cause → action plan → implementation
Observation period, effectiveness tracking and evaluation
Responsible team members on every step, with status and deadlines
Audit Management
Manage the full audit lifecycle and generate documentation from your own templates.
Internal, external, vendor and any other audit type
Planning → execution → observations → CAPAs → observation period → closure
Findings linked directly to CAPAs and related SOPs – nothing gets lost
Audit notification and follow-up letters, audit plan, report and certificate generated from your templates
Audit plans and outcomes tracked across the organization
SOPs & Controlled Documents
Manage controlled documents through review, approval, versioning and periodic review, with changes linked directly to training.
Creation, review, approval, versioning and periodic review
Collaborative review cycles with revision history and e-signatures
Transparency of all the review steps, responsible employees and timelines
Automated QMS triggers LMS: an SOP changed in QMS automatically re-assigns related training in LMS and sends out notifications
Corporate SOP library with role-based SOP assignment per employee
Training Records & Assignment
Every employee’s qualification story in one electronic record – assigned automatically, signed electronically.
Electronic records: CV, job description, applicable SOPs, internal and external training, certificates
Automatic and manual assignment, driven by the training plan and training matrix
Completion confirmed with 21 CFR Part 11-ready e-signatures
Automatic and manual assignment, defaults driven by the training plan
Centralized assignment by department, position, project or country
Content & Training Types
Initiate self-reported, trainer-led, recurring and mandatory training across all the training content formats
Self-training, trainer-led sessions, structured courses and recurrent training
Quizzes with different question types — measuring understanding, not just file opening
Online viewing in the browser, no downloads needed
Documents, slide decks, videos of any size, links and SCORM courses
Training library plus SOP and template libraries for employees
Reporting, Analytics & Inspection Readiness
Answer common QA and inspection questions without manual data collection
Training and quality dashboards with automatic alerts on overdue items
Export training records, SOP status, CAPA lists and evidence for any period
Completion reports for trainers, line managers and QA
Ad-hoc reporting across QMS and LMS — e.g. correlating training status with quality issues
Deep analytics — down to how long a specific quiz question took to answer
Why Flex LMS & QMS?
Since 2011, Flex has built software for regulated clinical operations. LMS & QMS brings that experience into one connected quality record: what happened, what changed, which SOP version is current and who is trained on it. More than 100 teams in 30+ countries use Flex, supported by teams in the US, Europe and Asia.
Quality tools track findings, training tools track courses — nothing connects them
One closed quality loop
From incident or audit finding to CAPA, updated SOP and completed training with electronic signature – one chain with traceability across every step.
SOP updates go out as email blasts with printed acknowledgment forms
SOP changes trigger training automatically
When a controlled document changes, related training is updated and reassigned automatically, and the training and SOP matrix updates with the current document version.
Nobody can say on the spot who's qualified to do what
A clear view of competence
See each person’s qualification status, the SOP versions they have completed and any outstanding gaps – by person, department, project or country.
Inspection prep means assembling records from five places for a week
Inspection readiness by design
Audit trails, electronic signatures, training matrices and SOP history remain available in the system, with records, CAPA lists and evidence exportable for any selected period.
Rigid QMS tools force your SOPs to fit the software
Your workflows, your views, your fields
Build your own flow for any activity – QMS documents, audits, CAPAs, incidents – and generate audit letters, plans, reports and certificates from your own templates.
Onboarding a study team means assigning trainings one by one
Batch assignment for start-up
Assign multiple trainings to a person or group in one action – by department, position, project or country – reducing manual assignment during onboarding and study start-up.
Quality lives in a separate tool from the platform running your trials
One platform with CTMS, eTMF and EDC
A deviation raised in trial operations can be routed into QMS, and training can be linked to study roles because quality runs on the same platform as clinical operations.
Enterprise-grade usually comes with an enterprise-grade invoice
Enterprise capability, sensible cost
Enterprise-grade quality and training capabilities without enterprise-suite complexity or cost. You pay for the modules you use.
Weeks of vendor training before anyone can log a deviation
Intuitive from day one, with people behind it
Employees access assigned training in a clear personal area, while QA works in configurable views. Flex experts support implementation and ongoing use.
Time to implement
Email & spreadsheets
Immediate, but nothing is controlled
Flex LMS & QMS
Typical go-live in 3–10 weeks
Legacy enterprise QMS / LMS
6–18 months
SOP change → re-training
Email & spreadsheets
Email blast, printed forms
Flex LMS & QMS
Automatic trigger, e-signed completion
Legacy enterprise QMS / LMS
Often two systems, manual sync
Audit lifecycle
Email & spreadsheets
Folders and Word documents
Flex LMS & QMS
Planning to closure, findings linked to CAPAs
Legacy enterprise QMS / LMS
Present, configuration-heavy
Changing a workflow
Email & spreadsheets
Nothing to change
Flex LMS & QMS
Built by your own team — flows, views, fields
Legacy enterprise QMS / LMS
Change request to the vendor
Inspection export
Email & spreadsheets
A week of manual collection
Flex LMS & QMS
Export records for any selected period
Legacy enterprise QMS / LMS
Reports exist, often per module
| Email & spreadsheets | Flex LMS & QMS | Legacy enterprise QMS / LMS | |
|---|---|---|---|
| Time to implement | Immediate, but nothing is controlled | Typical go-live in 3–10 weeks | 6–18 months |
| SOP change → re-training | Email blast, printed forms | Automatic trigger, e-signed completion | Often two systems, manual sync |
| Audit lifecycle | Folders and Word documents | Planning to closure, findings linked to CAPAs | Present, configuration-heavy |
| Changing a workflow | Nothing to change | Built by your own team — flows, views, fields | Change request to the vendor |
| Inspection export | A week of manual collection | Export records for any selected period | Reports exist, often per module |
One Platform That Grows With You
Add departments, projects and hundreds of employees while keeping the same login, training matrix and platform – without changing systems as you grow.
Your whole organization, not one team
Corporate, departmental and study-specific SOP and training libraries in one system — from dozens of people to thousands, with new companies or teams onboarded into the same structure.
Connects to what you already run
Flex supports common training content formats, customer templates and connections to other Flex modules, keeping quality and training records coordinated.
Access built around your org chart
Dedicated views for QA, training managers, line managers, project managers, employees, vendors and auditors — each role sees exactly what it needs, nothing more.
Onboarding that scales with your team
A named implementation lead supports teams of 10 or 500 through a typical 3–10 week go-live, while batch assignments reduce manual setup for each new hire.
Fits Into Your Stack, Live in Weeks
Keep your existing content and templates. Flex supports common formats and connects with other Flex modules so quality and training records remain coordinated.
Content and systems your team already uses
Flex LMS & QMS supports common content formats and customer templates, allowing existing materials to be reused.
- SCORM courses from your existing authoring tools
- Ad-hoc reporting across modules – training status vs quality issues
- Videos, slide decks, documents and links as training content
- Every other Flex module, on the same data model
- Your own templates for audit letters, plans, reports and certificates
Accessible anywhere
Cloud by default, on-premise if your policy requires it — either way, your team just opens a browser and works. No client software to manage, no manual updates to schedule.
HOSTING
Cloud or on-premise, your choice
ACCESS
Any browser, any device — plus a mobile app
SUPPORT
Named implementation lead
3–10
weeks from kickoff to go-live
Five Quality & Training Problems That Quietly Slow Down Every Team
These issues rarely appear as one major failure. Instead, they create repeated manual work, delays and gaps in traceability across quality and training processes.
SOP updates rely on email and printed forms
A new version is distributed by email, acknowledgment forms are printed and filed manually, making it difficult to confirm who completed the required training.
The training matrix lives in Excel
One person maintains it, and every organizational or document change creates a risk that it no longer matches the current SOP register.
CAPAs close without an effectiveness check
The action is implemented and the record is closed, but effectiveness may not be verified until the next audit.
Audit records scattered across folders
The plan is in one folder, findings in a spreadsheet and the report in email, so linking a finding to its CAPA and related SOP requires manual reconciliation.
Onboarding a new hire requires repeated manual follow-up
Each required training is assigned manually, tracked through reminder emails and confirmed with paper signatures for each person and assignment.
Recognize more than two of these?
That's usually the point where a unified LMS & QMS pays for itself before the next inspection.
How Flex LMS & QMS Fixes Each One
Each problem above maps directly to something the platform does differently — not a feature list, a fix.
The Problem
SOP updates by email blast and printed acknowledgment forms
What changes with Flex LMS & QMS
Document changes automatically trigger re-training, completed with 21 CFR Part 11-ready e-signatures
The Problem
Training matrix maintained by hand in Excel
What changes with Flex LMS & QMS
The training and SOP matrix updates automatically as documents and roles change
The Problem
CAPAs closed without effectiveness verification
What changes with Flex LMS & QMS
Observation period and effectiveness checks are configured steps in the workflow
The Problem
Audit records scattered across folders and email
What changes with Flex LMS & QMS
Full audit lifecycle in one place, findings linked to CAPAs and SOPs
The Problem
New-hire onboarding assigned training by training
What changes with Flex LMS & QMS
Batch assignment by department, position, project or country — in one action
| The Problem | What changes with Flex LMS & QMS |
|---|---|
| SOP updates by email blast and printed acknowledgment forms | Document changes automatically trigger re-training, completed with 21 CFR Part 11-ready e-signatures |
| Training matrix maintained by hand in Excel | The training and SOP matrix updates automatically as documents and roles change |
| CAPAs closed without effectiveness verification | Observation period and effectiveness checks are configured steps in the workflow |
| Audit records scattered across folders and email | Full audit lifecycle in one place, findings linked to CAPAs and SOPs |
| New-hire onboarding assigned training by training | Batch assignment by department, position, project or country — in one action |
What Actually Changes in Week One With Flex LMS & QMS
What a switch from another quality or training platform looks like in practice.
| Task | Typical QMS / LMS platform | Flex LMS & QMS |
|---|---|---|
| Onboarding a new study team | Trainings assigned individually per person | One batch assignment for the whole group |
| Rolling out an SOP revision | Manual re-assignment in a separate LMS | Document release automatically triggers re-training |
| Issuing an audit certificate | Written manually in Word each time, signed and scanned, buried in folders | Generated from your own template in the system |
| Correlating training gaps with quality issues | Two exports and a pivot table | One ad-hoc report across QMS and LMS |
| Getting a straight answer from support | Ticket queue, SLA measured in days | Direct line to a named implementation lead |
Task
Onboarding a new study team
Typical QMS / LMS platform
Trainings assigned individually per person
Flex LMS & QMS
One batch assignment for the whole group
Task
Rolling out an SOP revision
Typical QMS / LMS platform
Manual re-assignment in a separate LMS
Flex LMS & QMS
Document release automatically triggers re-training
Task
Issuing an audit certificate
Typical QMS / LMS platform
Written manually in Word each time, signed and scanned, buried in folders
Flex LMS & QMS
Generated from your own template in the system
Task
Correlating training gaps with quality issues
Typical QMS / LMS platform
Two exports and a pivot table
Flex LMS & QMS
One ad-hoc report across QMS and LMS
Task
Getting a straight answer from support
Typical QMS / LMS platform
Ticket queue, SLA measured in days
Flex LMS & QMS
Direct line to a named implementation lead
Why This LMS & QMS Fits Every Type of Team
One configurable core, not a different product per segment – each team gets what it actually needs from it.
CROs
Prepare for sponsor audits with training records, SOP history and CAPA evidence available for selected periods, while new project teams can be onboarded with batch assignment.
Sponsors
Vendor and internal quality in one system — audits of CROs, their findings, the CAPAs that followed and the re-training they triggered, all one traceable record.
Academic & research institutions
Assign role-based training to investigators and coordinators, with the same audit trail and controlled records used by commercial teams, without enterprise-scale IT overhead.
15+
Years of operations
500+
Companies using Flex Databases
45,000+
Users across the globe
100+
Clients
20,000+
Daily active users
10m+
Documents
2,000+
Clinical trials
30+
Countries
LMS & QMS Software: Frequently Asked Questions
Talk to us. See it yourself
Skip the generic demo. A specialist who works with this platform every day will walk you through it live, answer the hard questions directly, and show you exactly how it would run in your organization — not a script, not a slide deck.