This checklist lists the information required to set up a QMS workspace for a new client. Collect it once the client has confirmed, and share it with the implementation team.

Data collection templates: Sites · Departments · Users · Products · Materials · Documents · Equipment · Suppliers

1. Organisation Details

Field	Requirement	Notes
Organisation name	Required	2–100 characters. Also becomes the login address `https://<name>.<domain>`.
Time zone	Required	e.g. Asia/Kolkata
Language / region format	Required	English (US), English (UK) or German
Plan	Required	Starter, Professional or Enterprise
Number of users	Required	Default limit is 50
Document storage needed	Optional	Default limit is 10 GB
Address	Optional	Address lines, city, state, country, postal code
Billing details	Optional	Billing email, phone, tax ID (e.g. GSTIN), billing address

2. Administrator

The first user, who receives the welcome email and manages the workspace.

Field	Requirement
First name	Required
Last name	Required
Email	Required
Phone	Optional

3. Modules Required

The client selects at least one module. Modules marked Needs CAPA are enabled together with CAPA.

#	Module	Needs CAPA	Selected
1	Document Control	No	Yes / No
2	Training Management	No	Yes / No
3	Equipment & Calibration	No	Yes / No
4	CAPA	No	Yes / No
5	Quality Events (Deviations / Incidents)	Yes	Yes / No
6	Nonconformance	No	Yes / No
7	Change Control	No	Yes / No
8	Risk Management	No	Yes / No
9	Audit Management	Yes	Yes / No
10	OOS Investigations	Yes	Yes / No
11	Proficiency Testing	Yes	Yes / No
12	Complaints	No	Yes / No
13	Returned Goods	No	Yes / No
14	Management Review	No	Yes / No
15	Supplier Quality	No	Yes / No
16	Batch Release	No	Yes / No
17	Recall & Distribution	Yes	Yes / No
18	Product Registrations	No	Yes / No
19	Product Quality Review (APQR)	No	Yes / No

4. Organisation Structure

Sites

Field	Requirement	Notes
Site code	Required	At least 3 characters, e.g. `HYD` (used in change-control numbers)
Site name	Required
Site type	Optional	Manufacturing, Laboratory, Warehouse, Office or Distribution
Time zone, country, address	Optional
Parent site	Optional

Departments

Field	Requirement	Notes
Department code	Required	e.g. `QA`
Department name	Required
Site	Optional
Parent department	Optional
Department head	Optional	Email of the head

Positions / Designations: code and title (both required), and the department.

5. Users and Roles

Field	Requirement	Notes
First name	Required	Letters only
Last name	Required	Letters only
Email	Required	Used for login
Phone	Optional
Site, department, position	Optional
Reporting manager	Optional	Email of the manager
Role	Optional	Default: User
Can e-sign	Optional	Yes / No. Only enrolled users can sign approvals.

Ready-made roles: Full Access, User, Viewer, Quality Approver, plus dedicated roles for Complaints, Batch Release and Recall. Custom roles need a name and the permissions per module (view, create, edit, delete, approve).

6. Approvers

Each selected module comes with a ready-made approval workflow. The client names who performs each step: a person, a role, a group, the initiator's manager or the department head.

Common step	Example
Reviewer	QA Executive
Document Owner / Approver	QA Manager
Head of Department	Department head
Quality Manager / Quality Head	Head of Quality
CAPA Approver / Effectiveness Verifier	QA Manager
Lead Auditor	Internal Auditor
QA Reviewer / Authorised Person (Batch Release)	Qualified Person
Training Approver	Training Coordinator
Risk Owner	Process Owner

7. Documents to Migrate

List of existing SOPs, policies, forms and manuals, one row per document:

Field	Requirement	Notes
Document title	Required
Document type	Required	SOP, Work Instruction, Policy, Form, Record, Quality Manual or Template
Existing document number	Optional	To keep the current numbering
Department, owner, site	Optional
Review interval	Optional	e.g. every 24 months
Standards	Optional	e.g. ISO 9001, ISO/IEC 17025, 21 CFR Part 11
File	Optional	PDF, Word, Excel, TXT or CSV, up to 100 MB

Numbering: default format is PREFIX-YEAR-SEQUENCE (e.g. DOC-2027-0001, CAPA-2027-0001). If the client prefers to retain an existing format, record it here.

8. Module Master Data

Collect only for the modules selected.

Data	Required fields	Optional fields
Products	Code, name	Type, status, dosage form, strength, unit, regulatory class, UDI-DI, product family, description
Materials	Code, name, type (Raw, Excipient, Packaging, Intermediate, API)	Unit, critical (yes/no), description
Training courses	Course code, title	Type, linked SOP, duration, pass score, refresher interval
Training matrix	Course, applies to (everyone, department, site, position or role)	Due within (days)
Equipment / instruments	Asset tag, name, equipment type	Manufacturer, model, serial number, location, department, calibration frequency, maintenance frequency, purchase date, warranty
Suppliers	Supplier code, legal name	Trading name, type, country, tax ID, criticality, category, contacts
Distribution records (Recall)	Batch, consignee, shipped date, quantity	Unit, reference, region, country, warehouse

Products, materials, batches and distribution records can be imported in bulk from CSV.

9. Settings

Setting	What to collect
Working calendar	Weekly off days and holiday list (company-wide or per site)
Risk matrix	Size (3×3 up to 5×5) and risk levels. Default is 5×5.
E-signature	Whether creating, editing or deleting records also needs a signature (approvals always do)
Due dates	Default days for CAPA, complaints, reviews etc. (defaults are provided)
Security	Enforce two-factor login (MFA) and idle session timeout
Company email	SMTP host, port, username, password, sender name and email (to send emails from the client's own domain)
AI assistant	Provider, model and API key, if the client wants AI features

Implementation Sequence

Create the organisation workspace with the selected modules. The administrator receives a welcome email.
The administrator signs in, changes the password and sets up two-factor login.
Configure settings: calendar, risk matrix, e-signature, security and email.
Create sites, departments and positions, then users and roles.
Enrol e-signature users.
Assign approvers to each module's workflow and activate it.
Load master data (products, materials, equipment, suppliers, training).
Migrate existing documents, verify them with the client, then go live.