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ERP + Quality for Pharma
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ERP + Quality for Pharma · Available now

Keep every batch decision connected to its evidence.

ERP + Quality for Pharma keeps a manufacturing batch connected to its product, test results, deviations, corrective actions and release decisions. Production records the lot and its lifecycle.

Start now Download Proto
  • No per-user fees
  • Manual work is free
  • Configure it in Proto
OverviewCAPA effectiveness queue
ERP + Quality for Pharma · Capa actions

CAPA effectiveness queue

effective waits for the QA manager

New capa action
Capa actions in view
6
Pending effectiveness check
6
Due date within 14 days
3
Capa numberTitleDeviationOwner nameDue dateStatus
CA-41403Retrain blend time checksLate balance calibrationAmira Salcedo17 OctPending effectiveness check
CA-15808Add second balance verificationUnexpected fill weight variationDinesh Rao13 OctPending effectiveness check
CA-62379Revise vial seal inspectionAssay result outside alert rangeElise Moreau17 OctPending effectiveness check
CA-86379Install cold room alarm backupCold room temperature excursionTariq Mensah27 OctPending effectiveness check
CA-52191Audit carton label reconciliationCleaning rinse sample omittedHana Velasquez03 NovPending effectiveness check
6 of 6 records
Retrain blend time checksCapa actions · CA-41403
Pending effectiveness check
DeviationLate balance calibration
Owner nameAmira Salcedo
Due date17 Oct
Quality reviewCA-41403 · Retrain blend time checks

QA Manager decides whether the batch can be marked Approved.

Waiting for QA Manager
ApproveReturn
Example screen with sample data
Tables, ready to use
12
Saved views
13
Roles with set permissions
7
Reports and dashboards
9
Features

Follow every batch through quality review

Every feature works on the same records. Pick one to see the screen your team works in.

Batches and products

Follow a manufacturing lot from its product record through quality review and release.

  • Product identity
  • Lot identity
  • Lifecycle review
  • Products
  • Batches
Explore batches and products
OverviewApproved batches for release
ERP + Quality for Pharma · Batches and products

Approved batches for release

Batches

New
Batch numberProductStatusManufacture dateExpiry date
BTC-73602Norelis 10 mg sachetsApproved12 Oct18 Oct
BTC-94274Viresta 2 mg oral solutionApproved20 Oct27 Oct
BTC-52765Solmira 25 mg capsulesApproved24 Oct01 Nov
BTC-33080Neraval 10 mg tabletsApproved14 Oct19 Oct
BTC-85918Delmira 1 mg vialsApproved23 Oct28 Oct
6 of 6 records
Norelis 10 mg sachetsBatches · BTC-73602
Approved
Manufacture date12 Oct
Expiry date18 Oct
Example screen with sample data
Process

From lot record to release evidence

Batch quality to release ships ready to use. 2 steps need a named approval before the work moves on: Quality review (QA Manager) and Batch release (Qualified Person).

Drag a card to another stage, or focus it and use the arrow keys. It updates to match the stage.

  1. Batch planning

    Create the lot against its product and manufacturing context.

    Retrain blend time checksCA-41403 · Production Manager
    Batch planningBy Production Manager

  2. Testing

    Record outcomes against the batch and product specification.

    Retrain blend time checksCA-41403 · Production Manager
    TestingBy Production Manager

  3. Deviation review

    Investigate exceptions on the affected lot.

    Retrain blend time checksCA-41403 · QA Manager
    Deviation reviewBy QA Manager

  4. CAPA follow-up

    Track corrective work and its effectiveness result.

    Retrain blend time checksCA-41403 · QA Manager
    CAPA follow-upBy QA Manager

  5. Quality review

    Review tests, exceptions, changes and calibration before approval.

    Retrain blend time checksCA-41403 · QA Manager
    Quality reviewBy QA Manager
    ApprovalQA Manager decides whether the batch can be marked Approved.

  6. Batch release

    Record the human decision and reconcile the posting receipt.

    Retrain blend time checksCA-41403 · QA Manager
    Batch releaseBy QA Manager
    ApprovalQualified Person records the independent release decision.

Start with Batch quality to release

Inside a record

Keep quality evidence connected

Open any capa action to see the roles that work on it, its process stages and its approvals on one page.

  1. 1
    Record details

    Deviation, Owner name and Due date.

  2. 2
    Linked records

    Records linked to this capa action.

  3. 3
    Who works on it

    Admin, QA Manager and Qualified Person, each with their own permissions.

  4. 4
    Process stages

    CAPA follow-up, with the role that acts.

  5. 5
    Approvals

    Quality review and Batch release, with who decides.

CAPA effectiveness queueRetrain blend time checks
ERP + Quality for Pharma · Capa actions

Retrain blend time checks

Late balance calibration · Pending effectiveness check

Log activity
1
Record details
DeviationLate balance calibration
Owner nameAmira Salcedo
Due date17 Oct
3

Who works on it

  • AdminManage Users, Products, quality specifications, Equipment…
  • QA ManagerManage Deviations, capa actions, change controls, release…
  • Qualified PersonManage release decisions
4

Process stages

  • CAPA follow-upQA Manager
5

Approvals

  • Quality reviewQA Manager
    Approved
  • Batch releaseQualified Person
    Waiting
Example screen with sample data
Approvals

Make each release decision explicit

OverviewApprovals
ERP + Quality for Pharma · Overview

Approvals

Signed in as QA Manager

Waiting for you

4 To review1 Overdue2 Decided todayOnly mine
0 selectedApproveReturn
  • CC-70407Revise tablet blend hold time
    Requested by Admin
    Process0dActions
  • CC-53007Qualify alternate carton supplier
    Requested by Admin
    Specification4dActions
  • CC-66601Update assay sampling plan
    Requested by Admin
    Supplier3dActions
  • CC-74360Extend cold room monitoring
    Requested by Admin
    Equipment5dActions

Who approves what

DecisionApprover
Quality reviewReview tests, exceptions, changes and calibration before approval.QA Manager
Batch releaseRecord the human decision and reconcile the posting receipt.Qualified Person
Approve change controlsQA Manager
Approve release decisionsQualified Person
4 approval rules · set per role in Proto
Example screen with sample data
Who can approve what
Roles

A workspace for each role

Everyone opens ERP + Quality for Pharma to the work that is theirs. Pick a role to see what it starts with.

Admin

Sets up users, reference data and access for the operating team.

  • Manage Users, Products, quality specifications, Equipment, Suppliers
  • View Batches, test results, Deviations, capa actions, change controls, release decisions, operation receipts

Roles and permissions

Reports

See exceptions before they become overdue

Ask focused questions about batch status, exceptions, readiness and release evidence.

Overview
ERP + Quality for Pharma · Overview

ERP + Quality for Pharma dashboard

This quarter

Change controls in view
6
Process
1
Specification
1
Supplier
1

Capa actions by status

How far records got this quarter

StageReachedStep
Draft38
Open1642%
In progress638%
Pending effectiveness check233%

Number of capa actions by status

Sample counts per stage

0
-30Draft
-50Open
-60In progress
-20Pending effectiveness check
0Effective
Example screen with sample data
  1. 01Batch status by product

    Group batches by product and current status to see work awaiting review.

  2. 02Test outcome by specification

    Compare pass, fail and pending outcomes for each referenced specification.

  3. 03Deviation severity and status

    Show open investigations by severity, status and batch.

  4. 04CAPA due and effectiveness

    Show due dates, action owners and effectiveness outcomes for corrective actions.

  5. 05Change impact and decision

    Compare impact assessment, filing requirement and change status.

  6. 06Calibration attention

    List equipment by calibration status and next calibration date.

  7. 07Supplier qualification

    Review qualification state and next audit date by supplier.

  8. 08Release decision trail

    Follow each batch through review stage, decision, reviewer and rationale.

  9. 09Release receipt outcomes

    Compare succeeded, failed, skipped and pending release operations by batch.

All reports and dashboards

Who it's for

Built around pharmaceutical lot work

See how ERP + Quality for Pharma fits your kind of team.

Tablet manufacturing

Track tablet lots with product specifications, test outcomes and release decisions.

Injectable manufacturing

Connect injectable batch testing, equipment condition and release review.

Development products

Follow investigational product lots through controlled testing and quality decisions.

Controls

Trace the judgment and the operation

Each stage of batch quality to release names the role that acts and the status it records, so a change is never anonymous.

OverviewBatch quality to release
ERP + Quality for Pharma · Process

Batch quality to release

Each stage, the role that acts and the status it records

Process stages
11
Approval steps
2
Roles involved
4
Tables touched
10
Batch planning
Production Manager
StatusPlanned → in process
RecordsProducts, Batches
Deviation review
QA Manager
StatusOpen → under investigation → root cause identified
RecordsDeviations
CAPA follow-up
QA Manager
StatusPending effectiveness check → Effective
RecordsCapa actions, Deviations
Batch quality to release
  1. Start
    Batch planningPlanned → in process
    Products
  2. Step
    Deviation reviewOpen → under investigation → root cause identified
    Deviations
  3. Step
    CAPA follow-upPending effectiveness check → Effective
    Capa actions
  4. Approval
    Change approvalPending approval → Approved
    QA Manager
  5. Approval
    Quality reviewQA Manager
    Deviations
Example screen with sample data

See each stage in detail

AI agent

Prepare the next review with Proto

Use Proto to prepare batch reviews and guide people to the right records.

It can

  • Production Manager: Find batches awaiting testing or quality review and show the product and lot context.
  • QC Analyst: Gather pending results and their product specifications for review.
  • QA Manager: Bring open deviations, CAPA follow-up and calibration attention into a batch discussion.
  • Qualified Person: Prepare the linked evidence for a release decision and locate the operation receipt afterwards.

Stays with a person

  • A person must decide whether an exception is resolved, whether a change is approved and whether a batch is fit for release.
  • Proto can surface records and help with configuration, but the named reviewer must inspect the evidence and enter the decision.

Set up an agent

Integrations

Connects to the tools you use

Set up connections through ERP.AI and Proto workflows, with every change logged.

  • ERP + Quality for Pharma
  • Laboratory results
  • Equipment service records
  • Document evidence
  • Regulatory filing process
Data model

Your data, in tables you can change

Every record lives in a table you can see, extend and export. Add fields or whole tables in Proto.

Browse all 12 tables
12tables
  • Batches and products2
  • Specifications and testing4
  • Deviations and CAPA4
  • Change controls4
  • Equipment and suppliers4
  • Release decisions6
Implementation

Roll out one team at a time

Start with one team and one process, then add the rest once the basics are running.

  1. Reference setup

    Agree product codes, specifications, equipment and supplier records with the people who maintain them.

  2. Pilot lot

    Create a batch for one product with a clear number, quantity, line, site and dates.

  3. Quality rehearsal

    Record test outcomes, one investigated exception and a linked corrective action.

  4. Decision rehearsal

    Review the batch with QA Manager and Qualified Person, including a Hold case.

  5. Posting check

    Record the release decision, mark the reviewed batch Approved, then compare its Released status and operation receipt with that decision.

Read the implementation plan

Pricing

$0per user

The base account and everyday work in the ERP.AI app are free, for every user.

  • No per-user or per-seat fees
  • Viewing, editing, approving and exporting records in the app is free
  • Pay only for machine work: API calls, imports, workflows and AI agents
  • Prepaid credits from $5. Purchased credits never expire

Pricing details

Machine work rate card Included per $1 of credit

Machine work rate card
UsagePer $1
Record reads (list, filter, get)20,000
Search or aggregate queries4,000
Record writes4,000
Imported or synced records200,000
Workflow runs2,000
AI agent runs2,000
Scheduled jobs or webhooks20,000
File uploads (MB)2,000
CSV or PDF exports100
FAQ

Questions, answered

Scope, rollout and pricing for ERP + Quality for Pharma.

All questions
How do I get started?

Click Get started, then use Proto to configure ERP + Quality for Pharma for your business. Begin with one product, its specification and a representative batch.

How is a batch linked to a product?

The batch has a Product reference and its own batch number, quantity, dates, line, site and lifecycle status.

Where do test requirements live?

Quality specifications hold the product, test parameter, acceptance criteria, limits, effective date and version label.

How are test outcomes recorded?

QC Analyst enters a test results record for the batch with the observed value or text, outcome and analyst note.

What happens when a test raises a concern?

QA Manager can open a deviation against the batch, record the investigation and link corrective action to it.

How does CAPA follow-up work?

The action record holds the plan, owner name, due date, completion date and effectiveness check result. QA Manager reviews its status during batch quality review.

Can the team review equipment calibration?

Equipment records show calibration status, last calibration date, next due date and qualification status. The Quality Exceptions & CAPA page also brings out-of-calibration equipment into view.

Where are supplier changes reviewed?

A change controls record can reference a supplier and carries the impact assessment, filing requirement and approval status.

Who decides whether a batch is released?

Qualified Person records the independent release decision with its review stage, decision, reviewer and rationale. QA Manager marks the reviewed batch Approved only after a Release decision; the workflow posts every Approved batch.

What does a release receipt show?

Operation receipts record the performed batch release operation, its date, outcome, detail and evidence link. Review it with the batch and human decision.

Set up ERP + Quality for Pharma your way.

Start free, then use Proto to change fields, steps and approvals before your team goes live.

Start now Download Proto

How to get started

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