No version control
Outdated printed copies, SOPs spread across folders and doubts about which version is in force.
Annexa · GMP software by healthIT
GMP quality management software, always inspection-ready
Annexa brings document control, training, deviations, equipment, materials and change control into one platform with electronic signatures, a complete audit trail and traceability for every action, designed in line with EU GMP Annex 11.
- EU GMP Annex 11
- ALCOA+
- Electronic signatures
- Audit trail
- Microsoft 365
The challenge
When GMP quality lives in spreadsheets, folders and email, the risk shows up at inspection
Many GMP manufacturing sites still run their quality system on scattered tools. It works until an audit asks you to prove who did what, when, and on which version.
Training that is hard to prove
Read-and-understood lists on paper or in Excel that cannot be tied to each document version.
Incomplete traceability
Deviations, changes and equipment incidents recorded in different places, with no shared audit trail.
Hours lost preparing for audits
Weeks gathering evidence that should be one click away.
The solution
One platform for your entire pharmaceutical quality system
Annexa is a web application for running the pharmaceutical quality system (PQS) of GMP manufacturing sites: advanced therapy units, hospital pharmacies, cleanrooms and quality control laboratories.
Everything is recorded: every document, every read, every signature and every status change, with user, server date and time. When the inspector arrives, the evidence is already there.
- Unify. Documents, training, deviations, equipment, materials, OOS and change control share users, signatures and one audit trail.
- Control. Defined approval workflows, roles per manufacturing site and electronic signatures with meaning.
- Manage. A dashboard with the status of every module, automatic alerts and a task list for each person.
UTA-SOP-QA-004 · v03
Deviation management
- Draft
- In review
- Pending approval
- Approved
- Effective
- Obsolete
Signatures
- Reviewed · M. Puig (QC)
- Approved · J. Serra (QA)
Required reading38 / 42 signed
4 pending · escalated to the line manager
Locked PDF · SHA-256 7f3a 92c1 … 0b4e c91e
Modules
Integrated GMP quality management modules
Each module covers one part of the quality system and shares users, electronic signatures, notifications and the audit trail with the rest.
Grows with each module
Dashboard
An overview of every module: pending documents, overdue training, open deviations and upcoming equipment maintenance.
Available
GMP document control
Full lifecycle from draft to effective and obsolete, automatic numbering, assigned reviewers and approver, sealed PDF and periodic review.
Available
Document training
Required reading by role and area, read-and-understood signature per version, training period and escalated reminders.
Coming soon
Training and qualification
Training plans, staff qualification, media fills and task authorisations.
Coming soon
Deviations and CAPA
Recording, classification, root cause investigation and CAPA follow-up through to closure.
Coming soon
Reagents and materials
Inventory, batches, receipt, quarantine and release, with expiry alerts.
Coming soon
Equipment
Inventory, location, status, calibrations, preventive maintenance and warranties.
Coming soon
Out of specification (OOS)
Out-of-specification results, phased investigation and a documented final decision.
Coming soon
Change control and risk
Change requests, impact assessment, risk analysis and approval, with action tracking.
Notifications and email across every module
Each module sends in-app alerts that work as a personal task list. Important alerts also arrive by email, always with a link to the application and never with the document attached.
- Pending
- Read
- Done
Benefits
What your organisation gains
Inspection-ready, every day
Audit trail, signatures and version history available and exportable on demand. An audit stops being a project.
Always the right version
There is only one effective version of each document. Downloaded copies carry the user, the date and an “Uncontrolled copy” mark.
Provable training
See in real time who has read each version, who is pending and who is overdue, with alerts to the line manager.
Less paper, fewer errors
Electronic signatures with meaning, with no printing, scanning or archive binders.
No task gets lost
Everyone has their own list of alerts and reminders for periodic reviews, expiries and maintenance.
Data you can work with
Every list can be filtered and exported to Excel or CSV with all fields, and every export is logged.
Compliance and data integrity
Designed in line with EU GMP Annex 11 and ALCOA+
Annexa builds in from the start the controls that Annex 11 and the ALCOA+ data integrity principles expect from a GMP computerised system.
| Requirement | How Annexa meets it |
|---|---|
| Audit trail | Every creation, change, status transition, read and download is logged with user, server date and time, and reason for change. |
| Electronic signatures | Sign-in with Microsoft 365 plus a personal signing PIN. Each signature stores its meaning, the user, the date and the exact version signed. |
| Version control | Full revision history, a mandatory reason for every change and version comparison. Approved records cannot be deleted. |
| Document integrity | The approved PDF is locked and fingerprinted (hash) so any alteration can be detected. |
| Access control | Roles per manufacturing site and function: QA, QC, Qualified Person, production and technicians. |
| Periodic review | Review dates calculated automatically, with advance reminders. |
Supported validation (CSV)
Computerised system validation (CSV) is the responsibility of the regulated user. We support the process with requirements documentation and help with qualification.
Implementation
From shared folders to a validated system, step by step
We roll out Annexa module by module, so your quality team gets value from the first week without stopping operations.
Analysis
We review your quality system, roles, document numbering and approval workflows.
Configuration
We set up units, areas, document types, the required reading matrix and deadlines.
Migration
We import your existing documents with their original codes and launch the reading campaign.
Validation and training
We support system qualification and train administrators and users.
Support and evolution
Maintenance, versioned updates and new modules when you need them.
Technology
Open technology, no vendor lock-in
Built with open-source technology and no licence fees, with Microsoft 365 sign-in, deployment on your own server or in the cloud, and data you can always export. Start with document control and add modules without reinstalling.
- Open source
- Microsoft 365 SSO
- Signing PIN
- PDF + SHA-256
- Excel · CSV
- On-premise
- Cloud
- CA · ES · EN
Who it is for
GMP software for the teams accountable for quality
Advanced therapies
ATMP and cell production units in hospitals and research centres.
Hospital pharmacy
Services with GMP compounding areas, tissue and blood banks.
Quality control laboratories
QC laboratories that need provable documentation and training.
Pharmaceutical industry
Pharma and biotech SMEs with batch manufacturing.
- QA · Controls workflows, deadlines and evidence from a single dashboard.
- QP · Signs with confidence and has the full history at hand.
- Production and QC · Always finds the effective version and knows what is pending.
- Management · Sees the state of the quality system without asking for reports.
FAQ
Frequently asked questions about Annexa
Is Annexa validated for GMP?
Annexa is designed in line with EU GMP Annex 11. A computerised system is always validated in each organisation's specific environment and intended use; we support you with the documentation and help you need.
Can we import our existing documents?
Yes. We import your existing documents with their code, version and original approval date. They go live as effective and the system launches a reading campaign for all staff.
Do we need to buy every module?
No. You can start with document control and document training, and add the rest when you need it.
How do electronic signatures work?
Each user signs in with their Microsoft 365 account and signs with a personal PIN. Every signature records its meaning, date and time, and the exact document version.
Where is the data hosted?
On your own server or on hosting we manage for you, according to your security and data protection policy.
Is the application available in Spanish or English?
The interface is in Catalan and is ready for additional languages.
Get in touch
See Annexa with your own processes
In a 30-minute demo we walk you through the full document workflow, from draft to read-and-understood signature, and discuss how it fits your quality system.
Book a demo
info@healthit.cat