Standard Basis
MicroStats supports both Working Standard and Reference Standard workflows. The statistical core stays the same, but the preparation guidance and final conversion follow the selected basis.
Venus QC Lab · MicroStats
User Manual
MicroStats is the QC system for evaluating Enoxaparin batches at Venus QC Lab. It runs two assay types — Anti-factor Xa and Anti-factor IIa — and produces a calculation result, an audit trail, and a signed report.
You don't need a statistics background to use it. MicroStats checks everything automatically and tells you clearly if something needs your attention. Every action is recorded — so the record always shows who did what, and when.
Validated Reference Flow
In the validated reference-standard workflow, the test dilution remains fixed at 1. The controlled change is in the basis-specific preparation chain and final result conversion, not in free manual dilution entry.
Raw Material Xa
For Anti-factor Xa raw material, the controlled acceptance range is 90 to 125 IU/mg on the dried basis. Reviewers should confirm the stage and basis before interpreting the final output.
Doer
How to run an assay
You enter the absorbance readings from the lab, and MicroStats does the rest — regression, potency calculation, system suitability check, and report generation.
Workflow overview
flowchart LR
A([Log in]) --> B[Select assay\ntype]
B --> C[Click New\ndraft]
C --> D[Enter assay\ndata]
D --> E[Save\ndraft]
E --> F[Calculate]
F --> G{R² ≥ 0.98?}
G -- Yes --> H[Review\nresults]
G -- No\nRecheck data --> D
H --> I[Submit for\napproval]
I --> J([Record is\nSubmitted ✓])
style A fill:#e8f5f0,stroke:#007960,color:#007960
style J fill:#e8f5f0,stroke:#007960,color:#007960
style G fill:#fff9e6,stroke:#B45309,color:#6b4200
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Log in and go to the dashboard
Open MicroStats in your browser and sign in with your username and password. You will land on a blank dashboard with an empty form. Your previous records are listed in the Records & Audit panel on the right — click any record to open it. No record is pre-selected on login.
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Choose the assay type and create a new record
Use the Assay dropdown to select the assay type — Anti-factor Xa or Anti-factor IIa. Then click New draft. A unique MicroStats ID (MS-YYYY-MM-NNNN) is generated automatically, and the form unlocks for data entry.
If you are currently viewing a previous record and want to start a new one, click New draft once to clear the form and unlock the dropdown, then select your assay type and click New draft again to create it. -
Enter your assay data
First confirm the Stage and Standard Basis in the metadata section. Then type in the OD (absorbance) readings for each standard and test concentration — exactly as they appear on your plate reader printout. MicroStats checks your numbers as you type and will warn you if anything looks unusual, such as a flat standard curve or readings that are out of range.
You do not need to calculate anything manually. MicroStats handles the LOG10 transformation, linear regression, and potency calculation.If you choose Reference Standard, MicroStats changes the preparation guidance and the final conversion rule to the validated reference-standard path. The dilution column for the test rows remains fixed to the validated value for this workflow. -
Save your draft
Click Save to create a draft. Your data is stored securely. You can return and edit it later as long as the record is still in Draft status.
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Run the calculation
Click Calculate. MicroStats runs a full calculation — including a shadow verification (two independent calculation paths that must agree) — and checks system suitability. The R² value must be ≥ 0.98. If it is not, you will see a clear message telling you what to check.
What is R²? It measures how well your standards form a straight line. A value of 0.98 or above means the standard curve is reliable enough to use. If it is below 0.98, do not submit — recheck your readings or re-run the assay. -
Review the results
Read through the calculated potency and final activity values. Check the standard curve chart and the residual plot. These show whether your data fits the regression model well. If everything looks correct, move to the next step.
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Submit for approval (electronic signature required)
When you are satisfied, click Submit for Approver Review. Add a brief comment explaining what you did or anything the approver should know.
A pop-up will appear asking you to re-enter your login password. This is your electronic signature — it confirms your identity at the moment of submission. Enter your password and click Confirm (or press Enter). The record status changes to Submitted, and it moves into the approver's review queue.
Once submitted, you can no longer edit the record. If corrections are needed, the approver will return it to you with a written reason.If you enter an incorrect password, the submission will be blocked and the record stays in Draft. After 5 consecutive wrong attempts (across login and e-signature), your account will be locked — contact the Administrator to unlock it.
You are done for now.
Your record is in the approver's queue. If they return it to you, you will see it back in your dashboard in Draft status, with the approver's reason attached. Correct the issue, save, and resubmit.
Approver
How to review and approve
Your role is to independently verify that the result is correct and the record is complete before it is released as Final. Approving means you are satisfied — as the technical reviewer — that this record can be used for batch disposition.
Workflow overview
flowchart LR
A([Log in]) --> B[Check notification\nbadge]
B --> C[Open pending\nrecord]
C --> D[Review results\n& calculation trace]
D --> E{Your decision}
E -- Approve --> F([Record becomes\nFinal ✓])
E -- Return with\nwritten reason --> G([Record back\nto Draft])
G --> H[Doer corrects\nand resubmits]
style A fill:#e8f0ff,stroke:#0047BA,color:#0047BA
style F fill:#e8f0ff,stroke:#0047BA,color:#0047BA
style G fill:#fff9e6,stroke:#B45309,color:#6b4200
style E fill:#fff9e6,stroke:#B45309,color:#6b4200
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Log in and check the notification badge
When you sign in, look for the notification badge next to your name or in the header. It shows how many records are waiting for your review. If the badge is empty, there is nothing to action today.
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Open a pending record
Click on the record to open it. You can see all records across all users — not just your own submissions. Filter by Submitted status to find records waiting for your action.
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Review the results
Check the calculated potency, R² value, and final activity. Confirm that the Standard Basis and Stage match the source record, then review the standard curve chart and residual plot. These give you a visual sense of whether the data is consistent and the model fits well.
What to look for on the residual plot: Points should be scattered randomly above and below zero. A clear pattern — all points curving in one direction — may indicate a problem with the standard curve. -
Read the calculation trace
Scroll to the Calculation Trace section. Every formula, input value, and intermediate result is shown with a plain-language explanation. You do not need to re-calculate anything — the trace is your audit evidence that the right method was applied correctly.
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Review the audit trail
The audit trail shows every action taken on this record — who created it, when it was saved, when it was submitted, and what comments were added. Every entry is attributed to a named user with a timestamp.
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Approve or return (electronic signature required for approval)
If the record is correct and complete, click Approve & Sign Off and add your approval comment.
A pop-up will appear asking you to re-enter your login password. This is your electronic signature — it confirms your identity at the moment of approval. Enter your password and click Confirm (or press Enter). The record becomes Final. It is now locked and cannot be changed.
If something needs correction, click Return and write a clear reason explaining what the Doer must fix. The record goes back to Draft. (No electronic signature is required for returning a record.)
A Return comment should be specific. Instead of "Recheck data", write "OD reading for Standard 3 appears inconsistent with adjacent replicates — please verify against the plate reader printout."If you enter an incorrect password during approval, the action will be blocked. After 5 consecutive wrong attempts (across login and e-signature), your account will be locked — contact the Administrator to unlock it.
The record is Final.
A Final record is locked. The PDF report — including the calculation trace, standard curve, and audit timeline — is ready to download and file. The snapshot hash in the report footer proves the record has not been altered since it was finalised.
Administrator
How to manage users
Administrators access a separate portal at /admin. You cannot create or view assay records — your role is user management and system oversight.
Admin portal overview
flowchart LR
A([Log in →\n/admin portal]) --> B[Users tab]
B --> C{Action needed?}
C -- New staff member --> D[Create user]
C -- Account locked\nafter failed logins --> E[Unlock account]
C -- Staff leaving --> F[Deactivate user]
C -- Password forgotten --> G[Reset password]
A --> H[Activity tab]
H --> I[System summary\n& recent events]
A --> J[Audit Feed tab]
J --> K[All record events\nacross all users]
style A fill:#fff0f2,stroke:#EA0029,color:#EA0029
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Log in — you are taken to /admin automatically
When you sign in with an Administrator account, MicroStats redirects you to the admin portal. You will not see the assay dashboard — that is for Doers and Approvers only.
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Create a new user
Go to the Users tab and click Create User. Enter a username, assign a role (Doer, Approver, or Administrator), and set a temporary password. The user must change their password on first login.
Choose usernames that identify the person clearly — for example,firstname.lastname. This name will appear in the audit trail on every record the user touches. -
Unlock a locked account
After several failed login attempts, an account is locked automatically. In the Users tab, locked accounts are marked clearly. Click Unlock to restore access. The failed attempt counter resets.
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Deactivate a departing user
When a team member leaves, deactivate their account — do not delete it. Deactivation immediately invalidates their session and prevents future logins, but their name stays in the audit trail against all records they worked on. The historical record remains intact.
Never share login credentials. Each person must have their own account so that the audit trail correctly identifies who performed each action. -
Reset a password
In the Users tab, find the user and click Reset Password. Set a new temporary password and tell the user directly. Their existing session is invalidated immediately upon reset.
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Monitor system activity
The Activity tab shows a system summary — records by status, total audit events — plus a per-user breakdown and a recent event feed. Use this for a quick daily health check.
The Login History tab logs every login attempt — successful or failed — with username, result, IP address, and timestamp. The Audit Feed shows all record lifecycle events across all users. The Active Sessions tab lets you force-logout any session if needed.
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Download a database backup
Click Download Backup in the admin portal header. This streams a copy of the live database to your computer. Store it in a secure location. Repeat this regularly — especially before any system changes.
Your role is access control and oversight.
You do not approve assay records — that is the Approver's responsibility. Your job is to ensure the right people have access, accounts are current, and the system is being used as intended. A clean admin practice is the foundation of a valid audit trail.