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Regulix
User portal guideRP

Responsible Pharmacist user guide

Create and update QMS documents and risk, monitor staff reviews, and run reports including Inspection Pack.

1. Welcome

As Responsible Pharmacist, you help keep the pharmacy’s procedures, training evidence and risk records in good order. Your main jobs are to:

  • Create and update SOPs, work instructions and information posters
  • Send changes to the Superintendent Pharmacist (SP) for approval
  • Check that staff have read and confirmed the latest procedures
  • Manage the risk register and pharmacy files
  • Use reports (including the Inspection Pack) when preparing for visits
  • Keep your electronic signature and account details up to date

2. What you can and cannot do

TaskCan you do this?
Create and edit SOPs, work instructions and information postersYes (then sent to SP for approval)
View Approvals and SP commentsYes
Approve, Reject or Amend a documentNo — SP only
Archive a documentNo — SP only
Upload and view pharmacy documentsYes
See who still needs to review a procedure (Staff Reviews)Yes
Search across the pharmacyYes
Create, edit and download risk assessmentsYes
View reports and download the Inspection PackYes
View logs (activity, reviews, training, risk, staff)Yes
View staff training uploadsYes
Upload your own training certificateNo — Staff upload their own
Edit or delete other people’s training filesNo — SP / Admin
Use the AI Assistant (Ask, Draft, Verify, Duplicate check)Yes
Electronic signature, Login PIN and extra login securityYes

4. How to Sign In

  1. Open the Regulix eQMS login page in your web browser (use the link your pharmacy gave you).

  2. Enter your work email and password. If you have set a Login PIN, you can use that instead of your full password.

  3. If a security check appears (for example “I am not a robot”), complete it.

  4. If your pharmacy uses an extra security step, open your authenticator app on your phone and type the 6-digit code. If you cannot use your phone, use one of your recovery codes instead.

  5. Click Login. You should see your home page (Dashboard).

If you cannot sign in

  • Check that Caps Lock is off and that you are using the correct email.
  • Use Forgot password or Forgot PIN on the login page — you will get an email with reset instructions.
  • If your account has been switched off, ask an administrator to reactivate it.
  • If the security code keeps failing, wait a minute for a fresh code, or ask an administrator to reset the extra security step on your account.

Working at more than one pharmacy

If you cover more than one pharmacy, check the pharmacy name at the top of the screen after you sign in. Switch to the correct premises before you create documents, add risks or upload files.

Signing out

When you finish, click Logout at the bottom of the left-hand menu. Do not leave your account open on a shared computer.

5. Your Dashboard

The Dashboard highlights documents that are waiting for the Superintendent Pharmacist to approve, by type (SOP, work instruction, information poster).

  • Click through to Approvals to see the detail.
  • Always confirm the selected pharmacy first.

6. Creating and Updating Procedures

You work with three types of controlled documents:

Document numbers (for example SOP-…, WI-…, IP-…) are assigned automatically.

TypeTypical use
SOPStandard Operating Procedures — main pharmacy procedures
Work InstructionStep-by-step guides for a specific task
Information PosterNotices and posters for the pharmacy

Create a new document

As RP, a new document is saved and sent to the Superintendent Pharmacist for approval. It is not live for staff until the SP approves it.

  1. Confirm the correct pharmacy is selected at the top of the screen.

  2. Open Documents and choose SOPs, Work Instructions or Information Posters.

  3. Click Create.

  4. Enter a clear title and write the content. A draft layout may already be filled in from your organisation’s settings.

  5. Optionally:

    • Use Generate with AI to draft wording (see Section 15)
    • Run Verify with AI or a Duplicate check before you save
    • Attach a supporting PDF or Word file (maximum 5 MB)
  6. Save the document.

Edit an existing document

What happens next:

  • A new version is created and sent to the SP for approval.
  • Staff continue to see the last approved version until the SP approves.
  • You cannot edit again while a version is already waiting for approval. Wait for the SP to Approve, Reject or Amend.
  1. Open the document list and choose Edit from the actions.

  2. Make your changes.

  3. Enter a clear Reason for change (this is required).

  4. Save.

View, compare and history

From the document list you can:

  • View Document — open the approved PDF
  • Compare Versions — see differences between approved versions side by side
  • Version History — see versions, reasons, approver, comments and dates

Annual review dates

Approved documents usually have a next review date about one year ahead. Use the list filters and Reports → Overdue Reviews to manage items that are due soon or overdue.

7. Approvals (View Progress Only)

Open Approvals and choose SOPs, Work Instructions or Information Posters. Use the tabs: Pending, Approved and Rejected.

You can open a review screen to follow progress and read SP comments, but you will not see Approve, Reject or Amend buttons. That is expected for the RP role.

Typical journey

  1. You create or edit a document → it waits for approval.

  2. The Superintendent Pharmacist is notified by email.

  3. The SP reviews it, may amend it, then Approves or Rejects.

  4. If approved: the document becomes the current live version and staff are asked to review it.

  5. If rejected: the previous approved version stays in use, and you are notified with the SP’s comments.

8. Pharmacy Documents

Pharmacy Documents are files for the premises that sit alongside your controlled procedures (for example local evidence or supporting uploads).

  1. Confirm the correct pharmacy is selected.

  2. Open Pharmacy Documents from the left-hand menu.

  3. Upload a permitted file, or open / download an existing file.

  4. Use search or filters when the list is long.

9. Staff Reviews

Use Staff Reviews to see which approved documents are still waiting for staff to confirm they have read them.

  1. Open Staff Reviews from the left-hand menu.

  2. Filter by SOP, Work Instruction or Information Poster if needed. You can also search by document number or title.

  3. Open a row to see each staff member’s status for the current approved version.

  4. For a wider picture before an audit, also use Reports → Staff Review Completion and the Reviews log.

10. Reports (including Inspection Pack)

Change Register

Lists every approved document version with: Filter by document type and date range. Export a CSV if you need it for an inspection pack.

  • Reason for change
  • Who changed it
  • Who approved it
  • When it happened

Staff Review Completion

Shows which staff have confirmed the current approved version of each procedure, with a completion percentage. Export a CSV for evidence packs.

Overdue & Upcoming Reviews

  • Overdue — the next annual review date has passed
  • Due soon — due within the next 60 days
  • Use Mark Review Complete to record that you (or the SP) have completed the annual review; the next due date moves forward by one year
  • RP and SP receive weekly email reminders for due and overdue annual reviews

Inspection Pack

An inspection-ready summary for the selected pharmacy, including: Internal review outcomes include: Satisfactory, Minor Issues, Major Issues, Action Required. Pharmacy identity and the Superintendent Pharmacist are maintained by an administrator. Make sure your GPhC registration number is recorded on your user account so the pack is complete.

  • Pharmacy identity and SP/RP professional details
  • Status summary and readiness warnings (for example missing pharmacy details or missing GPhC numbers)
  • Counts for active documents, overdue reviews, due soon, and risk registers
  • Links through to SOPs, staff completion, risk register, change control and logs
  • Download PDF for the visit
  • Record a Pharmacy Internal Review — date, reviewer (active RP or SP), outcome, findings, corrective actions and next review date

11. Training Documents

When a staff member uploads training evidence, RP and SP are notified by email.

ActionRP
Upload your own certificateNo — staff upload their own
View training filesYes — active files for the pharmacy
Edit title or replace someone else’s fileNo
Delete training filesNo

12. Risk Register

Your electronic signature from My profile can appear on Risk Assessment PDFs — keep it current.

  1. Open Risk Register from the left-hand menu.

  2. Switch between General and Recall if needed. Search by RA number, title, principle or author.

  3. Click Create and complete:

    • Basic details
    • Risk assessment (likelihood × severity)
    • Mitigation
    • Effectiveness review
  4. Save each section. You can upload supporting reports.

  5. Later you can edit, add review comments, manage attachments, or download PDFs (single or all).

13. Logs

LogWhat it shows
ActivityKey actions on documents and users (create, submit, approve, reject, amend, review, archive, login, internal reviews)
ReviewsStaff acknowledgements — who confirmed what and when
Training DocumentsUploads, views, updates and deletions
Risk RegisterActivity on risk assessments
StaffIndividual staff review history

14. My Profile, Signature and Login PIN

Your signature can appear on Risk Assessment PDFs. Ask an administrator to keep your GPhC number (and job title or phone where relevant) up to date for Inspection Pack completeness.

If you forget your PIN, use Forgot PIN on the login page.

  1. Open My profile from the left-hand menu.

  2. Update your name or profile details if shown.

  3. Upload an electronic signature image (JPG, JPEG or PNG, maximum 5 MB) and save.

  4. Set or change your Login PIN so you can sign in without typing your full password every time.

  5. Manage the extra security step (authenticator app) on the same page — see Section 16.

15. AI Assistant

As RP you can use Ask, Draft, Verify and Duplicate check. These use your organisation’s AI allowance.

Ask mode

  1. Open AI Assistant at the top of the screen.

  2. Choose Ask.

  3. Ask about approved procedures in plain English.

  4. Read any sources shown with the answer.

Draft mode

  1. Choose Draft.

  2. Select document type: SOP, Work Instruction or Information Poster.

  3. Describe what you need (process, audience and key points).

  4. Send — review the draft carefully.

  5. Click Use in Create to open the matching Create screen with the draft loaded, or copy and paste it yourself.

On the Create page

  1. Click Generate with AI.

  2. Describe what you need.

  3. Insert the draft into the editor.

  4. Edit every line carefully before you save.

  5. Use Undo if you need to restore the previous content.

Verify and Duplicate check

On Create or Edit:

  • Verify with AI — review draft wording
  • Duplicate check — look for overlap with existing documents for the selected pharmacy

Important

  • AI wording is a starting point only. Review everything before you save.
  • Text is not a live controlled procedure until it has been approved through the normal process.
  • Never enter patient names, NHS numbers or other personal health details into AI.
  • If AI fails or is unavailable, ask an administrator to check the organisation’s AI allowance.

16. Keeping Your Account Safe

Login PIN

  1. Open My profile.

  2. Find Login PIN, enter a PIN you will remember, confirm it, then save.

  3. Next time you can sign in with your email and PIN.

  4. If you forget it, use Forgot PIN on the login page.

Extra security step (authenticator app)

Your organisation may require an authenticator app (for example Google Authenticator or Microsoft Authenticator). You can view or create new recovery codes later from My profile. Old codes stop working when you create a new set. If you lose access to your phone and your recovery codes, ask an administrator for help.

  1. Open My profile and choose Enable under the security section.

  2. Scan the QR code with your app (or type in the setup key).

  3. Enter the 6-digit code and confirm.

  4. Store the recovery codes somewhere safe. You need them if you lose your phone.

17. Emails You May Receive

WhenTypical involvement
A document needs approvalSP receives the approval request
A version is approved or rejectedYou are notified; staff are notified on approve
Staff upload training evidenceRP and SP are notified
Weekly pending staff reviewsStaff with outstanding acknowledgements
Monthly staff review summaryRP and SP
Weekly due / overdue annual reviewsRP and SP

18. Document Status — Plain Meanings

StatusMeaning
DraftNot yet live
ActiveCurrent approved document in use
ArchivedTaken out of day-to-day use (history kept)
Pending ApprovalWaiting for the SP to decide
Approved (version)Approved and becomes the live version
Rejected (version)Not approved; previous live version stays in use

19. Quick Goal Finder

I want to…Where to go
Create a new SOPDocuments → SOPs → Create
Draft wording with AICreate → Generate with AI, or AI Assistant → Draft → Use in Create
Verify or check for duplicatesCreate / Edit → Verify with AI / Duplicate check
Ask about an approved procedureAI Assistant → Ask
Find something quicklySearch
Send an edit for approvalActions → Edit → save with reason
Check approval progressApprovals (view only)
Upload a pharmacy filePharmacy Documents
See who still needs to acknowledgeStaff Reviews, or Reports → Staff Review Completion
Mark annual document reviewReports → Overdue Reviews → Mark Review Complete
Prepare for inspectionReports → Inspection Pack → Download PDF
Record a pharmacy internal reviewReports → Inspection Pack → Record Review
Add a risk assessmentRisk Register → Create
Upload signature / set PIN / securityMy profile

Common problems and tips

ProblemWhat to try
Wrong pharmacy’s dataSwitch pharmacy at the top of the screen before creating or editing
Document locked for editingA version is waiting for approval — wait for the SP to Approve, Reject or Amend
No Approve / Reject / Amend buttonsExpected for RP — only the SP can decide
Cannot sign in / forgotten PINUse Forgot password or Forgot PIN on the login page
Security code not workingUse a recovery code, or ask an administrator to reset security on your account
Inspection Pack warningsAsk an administrator to complete pharmacy settings; check your GPhC number is on your user record
AI draft or verify failsAsk an administrator to top up AI allowance; always review AI text before save
Need a clear change historyAlways write a clear Reason for change
Need a quick answerOpen Help support and check the FAQ

Need more help?

  1. Open Help support from the bottom of the left-hand menu.

  2. Read the FAQ first.

  3. If you still need help, fill in the contact form with a short subject and a clear description of the problem.

  4. You may attach one screenshot (PNG, JPG, GIF or WEBP, up to 2 MB). Do not include patient or personal health information.

  5. Send the message. Support will reply to your account email.

For professional decisions on procedures, speak with your Superintendent Pharmacist.

Looking for another role? Browse all role guides.