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Life sciences · 21 CFR Part 11 · EU GMP Annex 11 · 21 CFR 210/211 · GLP · GCP

GxP records your team builds, with the controls inspectors expect.

Biotech, pharma, cell and gene therapy, biorepositories and CDMOs: run deviations, CAPA, change control, SOPs, training, samples and equipment in one workspace, shaped to your process, with Part 11 signatures and a validation package with every release.

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What you keep in Qualsted
  • Deviations, investigations and CAPA, linked both ways
  • Change control with impact assessment and approval
  • SOPs and controlled documents with periodic review
  • Training records and curricula, with reminders when training is due
  • Samples, results against specifications, and storage locations
  • Equipment, calibration and supplier qualification
Who uses it
  • Quality assurance and quality control
  • Manufacturing and process development
  • Clinical and research operations, biorepositories

People who only need to look, such as managers, auditors and customers, get free viewer seats.

In practice

What it looks like.

A released lot: the signature chain shows a second person signed it with the meaning Released for use, beside an append-only audit trail.
A lot released by signature, with its audit trail.
Lots in stock sorted by expiry date, with days to expiry, quantity, storage location and release status.
Lots in stock, soonest expiry first.

Screens show sample data from a fictional company.

How it supports your standard

The clauses your auditor asks about, and what answers them.

Qualsted gives you the technical controls and the records; your procedures, training and verification of your own configuration complete the picture.

Clause How Qualsted helps
21 CFR 11.10(e) · Annex 11 §9 Audit trails. Every change to every record, with who, when and the values before and after, kept as long as the record and append-only in the database.
21 CFR 11.50, 11.70, 11.200 · Annex 11 §14 Electronic signatures. Printed name, date and time and meaning on every signature, a fresh password or single sign-on at signing, linked to the exact content signed.
21 CFR 211.192 Investigations of discrepancies. Deviation records with investigation, impact assessment and QA approval, and a CAPA opened from them when needed.
21 CFR 211.198 Complaint files. Complaints from receipt to closure, with the reportability decision and QA approval recorded.
21 CFR 211.25 · Annex 11 §2 Training. Who was trained on what, when and by whom, signed by trainee and trainer, with reminders when it falls due.
Annex 11 §4, §10 Validation and change management. A validation report with every release (requirements traced to tests); every change to your configuration is in the audit trail.
Templates

Start from these, installed in one click.

Working processes with review signatures, reminders and views set up, as ordinary tables and pages you can change.

Quality

Deviations and CAPA

Record deviations, assess their impact, and open a corrective and preventive action when one is needed. CAPAs are reviewed and approved, with reminders before they fall due.

  • Deviations 15 columns · IDs like DEV-0001 · signed: QA approval
  • CAPA 13 columns · IDs like CAPA-0001 · signed: Reviewed by, Approved by
  • Reminder: Deviation due in 3 days
  • Reminder: Deviation overdue
  • Reminder: CAPA due in 3 days
  • Reminder: CAPA overdue

21 CFR 211.192 · FDA QMSR (21 CFR 820) · ISO 13485 §8.5.2 · ISO 9001 §10.2 · EU GMP Ch. 1

Quality

Change control

Propose, assess and approve changes to processes, equipment, materials or documents before they're made.

  • Change requests 13 columns · IDs like CC-0001 · signed: Assessed by, Approved by
  • Reminder: Change due in 3 days
  • Reminder: Change overdue

FDA QMSR (21 CFR 820) · ISO 13485 §7.3.9 · ISO 9001 §6.3 · EU GMP Annex 15 · ICH Q10

Quality

Document control (SOPs)

Controlled documents with versions, review and approval. Each document gets a periodic review date two years ahead, and its owner is reminded a month before it's due.

  • Documents 11 columns · IDs like DOC-0001 · signed: Reviewed by, Approved by
  • Reminder: Periodic review due in 30 days

21 CFR 211.100 · FDA QMSR (21 CFR 820) · ISO 9001 §7.5 · ISO 13485 §4.2.4 · ISO/IEC 17025 §8.3

Quality

Training records

Who was trained on what, when, and by whom, with trainee and trainer sign-off and reminders when training falls due.

  • Training records 10 columns · IDs like TRN-0001 · signed: Trainer sign-off
  • Reminder: Training due in 7 days
  • Reminder: Training overdue

21 CFR 211.25 · FDA QMSR (21 CFR 820) · ISO 9001 §7.2 · ISO 13485 §6.2 · ISO/IEC 17025 §6.2

Lab

Sample log and results

Receive samples with unique IDs and storage locations, record test results against specifications (pass or fail is calculated), and have them reviewed.

  • Samples 10 columns · IDs like SMP-0001
  • Results 12 columns · IDs like RES-0001 · signed: Reviewed by
  • Reminder: Report due tomorrow

ISO/IEC 17025 §7.4 · §7.5 · §7.8 · 21 CFR 211.194 · GLP (21 CFR 58)

Operations

Equipment and calibration

An equipment register with calibration records reviewed by Quality, and reminders two weeks before calibration falls due.

  • Equipment 8 columns · IDs like EQ-0001
  • Calibrations 9 columns · IDs like CAL-0001 · signed: Reviewed by
  • Reminder: Calibration due in 14 days
  • Reminder: Calibration overdue

21 CFR 211.68 · FDA QMSR (21 CFR 820) · ISO 9001 §7.1.5 · ISO/IEC 17025 §6.4 · ISO 13485 §7.6

See all templates

AI assistant · add-on

Ask your records, in your own words.

The assistant answers questions about your tables, draws charts and summarizes long records. It sees only what you can see, never changes or signs anything, and every use is logged.

How the assistant works

Help · Ask the assistant

Summarize DEV-0117 for the batch review.

Chart open CAPAs by owner and stage.

Answers come from the records you can see, with charts and links to them.

Questions

What life sciences teams ask us.

Is it validated?

Every release is validated by us with an automated test suite, traced to the requirements and to Part 11 and Annex 11 in a signed report. You verify your own configuration and intended use, scaled to risk as FDA's Computer Software Assurance guidance describes; the report is designed to support that.

Can it replace our paper batch records?

It can hold electronic batch and production records you build as tables and pages with checklists stamped by the server. Start with one product or process and check it against your procedures first.

See it with your own process

Bring one workflow. We'll build it with you in the demo.

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