What it automates
Approval routing, escalation, training assignment, expiry notification, change control, deviation handling, supplier requalification, report generation.
Software Solutions
Your most critical operations deserve tools built for the job.
We build bespoke software to automate workflow, centralise document control, and make the supply chain traceable. Designed around your actual processes.
Workflow automationDocument controlSupply chain traceabilityCompliance by designIntegration-ready
Bespoke software built for your process. No off-the-shelf product licensing.
Self-assessment
How mature is your digital compliance infrastructure?
Six questions covering your current tooling, data governance, and readiness for audit-trail-compliant digital operations.
6 questions, around 5 minutes
Personalised PDF report with archetype classification and gap analysis
Optional 30-minute review call with a Clear consultant
We collect your email at the halfway point. Privacy policy.
PREVIEW
Your Report
Foundation
CoverageYou
Maturity
Optimisation
Methodology
Built on real audit experience.
Based on EU Annex 11 requirements and ALCOA+ data integrity principles. Clear has designed and implemented compliance software for cannabis operators and pharmaceutical facilities operating under EU-GMP and GACP frameworks, with direct experience of what inspectors examine in computerised system validation.
Sample
The questions that matter.
“Do you currently manage batch documentation, traceability, or deviation records using digital tools?”
“Are your electronic records protected against unauthorised modification and backed up with version control?”
“Does your team use spreadsheets or manual processes where a validated system would be required under inspection?”
5 archetypes
Where you stand. What you can do.
Foundation
First stages of the compliance journey. Basic systems and documentation not yet formally in place.
Coverage
Compliance frameworks in progress, with partial implementation. Gap analysis and prioritisation are the main focus.
Maturity
Mature systems with specific gaps remaining. Targeted remediation to close priority observations.
Optimisation
Near full compliance with refinement needs. Audit readiness and continuous improvement as the next horizon.
Next steps
A report, then options.
Right after submission
- ✓Your 3-page PDF report delivered to your email
- ✓Archetype classification with detailed reasoning
- ✓Concrete next steps tailored to your position
If you want to discuss
- ✓Optional 30-minute call with a Clear consultant
- ✓No commitment, no sales follow-up unless requested
- ✓Schedule directly via Zoom Scheduler
Recognition
Does any of this sound familiar?
Individually, each of these looks manageable. Together, they describe an operation that is one inspection, supplier incident, or audit request away from a problem that costs more than the system to fix it.
The hidden cost
When processes are critical, fragmented tools become an operational risk.
Audit trails, approval workflows, and version control require purpose-built systems. Spreadsheets, email, and shared folders cannot record who read what, who approved what, or which version was current when a decision was made.
The signs accumulate gradually. A document circulated in three different versions on the same day. An approval sitting in an inbox for two weeks. A supplier certificate that expired three months ago. A batch record assembled manually from five different sources every release.
Individually, each looks manageable. Collectively, they represent operational risk: to compliance, to efficiency, and to the decisions being made on incomplete or unreliable information.
What bespoke means
A bespoke software solution is a system built around your workflow.
We start by mapping how your processes actually work, identify where friction, errors, and manual work are concentrated, then build the modules, automation, and integrations that eliminate them.
What it connects
ERP, QMS, LIMS, CRM, inventory systems, document repositories, and authentication providers. API-first, no double entry.
What it makes visible
Document status, approval bottlenecks, supplier certificate expiry, batch traceability, training compliance, real-time operational KPIs.
Use cases
What we build and the workflows it replaces.
Ten common workflows organised into three areas, each moving from fragmented tools to controlled, traceable, automated systems.
Document workflows
SOP lifecycle management
Replaces
Email + shared folder + manual tracker
What the system does
Version control, approval flow, effective date, training trigger
Outcome
SOPs always current, approved, and recoverable
CAPA workflow
Replaces
Excel tracker + email follow-up
What the system does
Root cause, actions, owner assignment, escalation, closure verification
Outcome
CAPA cycle time reduced, traceable end to end
Change control
Replaces
Email + paper form + manual log
What the system does
Structured request, impact assessment, routing, implementation verification
Outcome
Change history complete, no unauthorised changes
Training records
Replaces
Spreadsheet + email confirmation
What the system does
Assignment, completion tracking, quiz, retraining trigger, dashboard
Outcome
Training compliance visible in real time
Document management
Replaces
Shared folder + email + manual index
What the system does
Single repository, version control, role-based access, expiry alerts
Outcome
Documents always in their current, approved version
Operations workflows
Electronic batch record
Replaces
Manual paper or Excel
What the system does
Structured step-by-step completion, QA review, release approval
Outcome
Batch records complete, error-proof, audit-ready
Approval automation
Replaces
Email chains + manual follow-up
What the system does
Routing, SLA tracking, escalation, electronic signature, audit log
Outcome
Approvals faster, traceable, compliant
Reporting and dashboards
Replaces
Manual Excel reports
What the system does
Real-time dashboards for operations, compliance, supply chain, executive
Outcome
Decisions made on live data instead of stale exports
Supply and reporting
Supplier qualification
Replaces
Excel + email + PDF attachments
What the system does
Qualification form, document upload, review workflow, approval, requalification trigger
Outcome
All supplier statuses visible, certificates tracked
Supply chain traceability
Replaces
Multiple spreadsheets + emails
What the system does
Supplier portal, document tracking, batch linkage, expiry management
Outcome
Full chain of custody visible and traceable
Services
From process discovery to live system.
What we do at each stage of the engagement. Scope and deliverables are agreed before any code is written.
Process discovery and workflow mapping
Structured analysis of current processes, friction points, automation opportunities, and integration dependencies.
Solution architecture
Custom system design including modules, data model, integration map, user roles, and compliance requirements.
UX and interface design
Interfaces built around how real users work. Adoption follows design quality, removing the burden from training.
Custom software development
Backend, frontend, automation rules, API integrations, role-based access, audit trail, version control.
System integrations
Connections to ERP, QMS, LIMS, CRM, and inventory systems. API-first, no double entry.
Workflow automation
Automated notifications, task assignment, escalation, approval routing, reminders, and SLA tracking.
Dashboards and reporting
Real-time operational and executive dashboards, configurable KPIs, automated report generation.
Validation support
Documentation, risk assessment, IQ and OQ and PQ support where required (Annex 11, GAMP 5, 21 CFR Part 11).
Testing and rollout
End-to-end testing, UAT, phased rollout, team training, and structured documentation.
Post-go-live support
Maintenance, bug resolution, feature extensions, performance monitoring, and continuous improvement.
How we work
A process-first method. The software adapts to your operation.
Every engagement starts with understanding the workflow before any line of code. Nine structured phases from first conversation to ongoing support.
01
Process discovery
Structured sessions to map current workflows, identify friction, quantify manual effort, and define automation opportunities.
02
Workflow mapping
Visual documentation of process flows, roles, decision points, handoffs, document types, and compliance requirements.
03
Solution architecture
System design including modules, data model, user roles, integration map, audit trail logic, and compliance considerations.
04
Prototype and MVP
Working prototype of the highest-priority module for early validation, feedback, and iteration before full build.
05
Development
Iterative development in modules. Transparency on progress, testing at every stage, no surprise milestones.
06
Integrations
API connections to existing systems, data migration where required, no stranded data.
07
Testing and UAT
Functional testing, user acceptance testing, compliance checks, and performance validation.
08
Rollout and training
Phased deployment, team onboarding, documentation, and change management support.
09
Post-go-live support
Issue resolution, continuous improvement, feature extensions, and ongoing performance monitoring.
Who it is for
Built for organisations whose processes are too critical for a standard tool.
Blocked by Excel and email
Your most critical workflows run on spreadsheets with no audit trail, no version control, and no automated approvals.
We replace fragmented tools with a system that knows who did what, when, and why.
Scaling and hitting operational limits
More teams, more suppliers, more documents. Your current systems are slowing you down rather than supporting you.
We build the operational infrastructure to scale without adding manual headcount.
Regulated operations and compliance exposure
You manage SOP lifecycle, CAPA, change control, deviation, training records, and supplier files with tools that pre-date these requirements.
We build controlled, auditable, inspection-ready workflows.
Complex supply chain with dispersed data
Supplier status, certificate expiry, batch linkage, and qualification documents are scattered across systems, inboxes, and shared drives.
We build a supply chain visibility layer that connects the dots.
Systems that stay siloed from each other
ERP, QMS, LIMS, CRM, and inventory live separately, with manual data movement between them.
We build the integration and automation layer that connects what you already have.
Regulated digital records and Annex 11
You use digital systems to manage GMP-relevant data. Electronic records, audit trails, access controls, and electronic signatures need to meet Annex 11 or 21 CFR Part 11 requirements.
We build computer systems with regulatory compliance designed in from the architecture up.
Case studies
What changes when the system works.
Case 01: Medical cannabis producer
Before
SOP lifecycle, training records, and CAPA workflow managed across email, Excel, and a shared folder. Ahead of a competent authority inspection, the QA manager struggled to rapidly retrieve current approved SOPs or demonstrate training completion.
System built
Document management and quality workflow system with version control, approval routing, training assignment, and electronic acknowledgement.
Results
142 SOPs centralised, versioned, and retrievable in under 30 seconds. Training compliance moved from manually tracked in Excel to a live dashboard.
Case 02: Supply chain operator
Before
Supplier qualification across three markets handled via email, PDF attachments, and a master Excel tracker. Certificates expired without notification. A supplier incident revealed that qualification records for a critical packaging supplier were three years out of date.
System built
Supplier qualification portal with document upload, expiry tracking, automated requalification triggers, approval workflow, and a real-time status dashboard.
Results
Zero expired certificates in the following audit. All supplier statuses visible to procurement and QA simultaneously.
Case 03: Pharmaceutical distributor
Before
ERP for inventory, a QMS for quality documents, LIMS for laboratory data. Three systems with no data flow between them. Reports assembled manually every week from three different exports.
System built
Integration layer and operational dashboard connecting all three systems, with automated reporting, alert logic, and a single operational view.
Results
Weekly reporting time reduced from four hours to fifteen minutes. Operational decisions made on live data instead of stale exports.
No system can guarantee the outcome of an inspection, audit, or certification review. Validation responsibility remains with the client organisation.
Credentials
Technical depth meets operational and regulatory experience.
We are software engineers who have worked inside regulated operations. We understand audit trail, change control, electronic signature, and validation as architectural requirements, baked into the system from day one.
FAQ
Technical and operational questions answered directly.
Free resource
Bespoke vs off-the-shelf: a decision framework
A structured framework for deciding when to build, when to buy, and when a hybrid is the right answer. Covers 12 decision criteria including compliance requirements, integration complexity, total cost of ownership, and timeline to value.
Let us map the workflows that are costing you the most.
Thirty-minute process discovery call. No commitment, no generic pitch. We listen to the situation, identify the workflow, and tell you what is possible.