Controlled documents
SOPs, Work Instructions, and posters in one place
Numbered controlled documents with version history, compare versions, and archive when needed.
Regulix-eQMS for pharmacy teams
Quality management built for pharmacy teams
Create, approve, and prove SOPs and procedures — with staff acknowledgements, risk and change control, and an Inspection Pack ready for visits.
Controlled documentsStaff acknowledgementsInspection-ready evidence
01
Controlled documents
SOPs, Work Instructions, and posters with version history.
02
Approval workflow
Superintendent decisions recorded with reason-for-change.
03
Staff acknowledgement
Read-and-understand tracking with reminders.
04
Inspection Pack
One downloadable pack with readiness warnings.
The pressure
Paper folders and scattered files do not survive inspection pressure
When evidence is spread across drives, inboxes, and spreadsheets, teams lose hours proving what they already do well.
Gap 01
Procedures in shared drives
Versions multiply, ownership blurs, and nobody is sure which SOP is current.
Gap 02
Acknowledgements in inboxes
Read-and-understand evidence sits in email threads instead of the record.
Gap 03
Risk kept somewhere else
Assessments and change history live outside the quality system entirely.
Regulix-eQMS brings controlled documents, reviews, risk, change history, and audit logs into one pharmacy-ready system.
One system of record
How it works
From draft to proof in three controlled steps
Every document follows the same path, so the audit trail builds itself as your team works.
Core capabilities
Everything your pharmacy QMS needs in one place
Purpose-built modules that map to how pharmacy quality actually works — not a generic document store.
Approval workflow
Superintendent decisions, clearly recorded
SP Approve, Reject, or Amend. RP authors; Staff keep the last approved version until the next one is live.
Staff review
Read-and-understand, with an audit trail
Staff acknowledge approved documents. Track pending, overdue, and completion — with reminders when reviews are outstanding.
Training evidence
Certificates where they belong
Staff upload training files; RP and SP oversee the record for audits.
Risk register
General and recall risk in system
Capture likelihood × severity, mitigation, and effectiveness. Use a view-only Risk View role when someone only needs to look.
Change and reports
Change Register and review reports
Export change history and staff review completion. Flag overdue and upcoming annual reviews.
AI Assistant
Ask and draft from approved procedures
Ask questions grounded on approved documents. RP and SP draft wording — always reviewed before it becomes controlled.
Inspection Pack
One pack for the visit
Pharmacy identity, SP/RP details, document status, internal reviews, and deep links to evidence — downloadable PDF with readiness warnings.
Inspection readiness
Walk into the visit with everything in one pack
Instead of assembling folders under pressure, generate a single inspection-ready pack with readiness warnings before anyone arrives.
- Pharmacy identity with SP and RP details
- Document status across SOPs, WIs, and posters
- Internal review and completion evidence
- Deep links to risk, change register, and logs
Roles and access
Built for how pharmacy teams actually work
Five role types with the rights each job needs — so responsibility and access always line up.
Staff
Read and acknowledge procedures, upload training evidence, and ask the AI about approved documents.
- Acknowledge documents
- Upload training files
- Ask the AI
Responsible Pharmacist
RPDraft and update QMS documents and risk, monitor approvals, and run reports including Inspection Pack.
- Author documents
- Manage risk
- Run reports
Superintendent Pharmacist
SPMake final Approve, Reject, or Amend decisions and oversee quality, training, risk, and logs.
- Final approval
- Quality oversight
- Full visibility
Risk View
View risk assessments without create, edit, or download rights.
- Read-only risk access
Admin
Manage users, pharmacy profile, email and AI settings, and system setup — separate from day-to-day portal work.
- User management
- Pharmacy profile
- System settings
AI Assistant
AI that stays tied to your controlled documents
Ask mode answers from approved documents. Draft mode helps RP and SP start new wording faster. AI text is not controlled until someone reviews and approves it — and prompts should never include patient-identifiable data.
Ask mode
Answers resolve against approved SOPs, Work Instructions, and posters — with the source document shown.
Draft mode
RP and SP generate starting wording faster, then review every line before it becomes controlled.
Trust and security
Built for accountability
Structured access, authentication, and logs designed for teams that have to prove what they did — and when.
Role-based access
Staff, RP, SP, Risk View, and Admin — each limited to the rights their work requires.
Two-factor authentication
Available at organisation and account level to protect quality records.
Electronic signatures
For risk PDFs where configured, so sign-off is captured with the evidence.
Full audit trail
Activity, review, training, and risk logs give a clear chain of accountability.
5
Role types with scoped access
3
Controlled document types
1
Pack for the whole visit
Frequently asked
Everything you need to know
Straight answers on ownership, approval, and what a demo covers.
UK pharmacy teams that need electronic QMS for procedures, staff acknowledgement, risk, and inspection readiness.
The Superintendent Pharmacist. RP drafts and edits; Staff acknowledge approved versions.
An inspection-ready view of pharmacy identity, SP/RP details, document status, internal reviews, and links to evidence — with PDF download.
No. AI helps ask and draft; controlled status only after human review and SP approval where required.
Request a demo, or email sales with your pharmacy context.
No commitment · 30-minute walkthrough
See Regulix-eQMS in action
Book a short walkthrough tailored to your pharmacy — documents, approvals, staff reviews, risk, and Inspection Pack.
- Documents and approvals
- Staff reviews and training
- Risk, change, and Inspection Pack
Prefer email? [email protected]