Rows of servers in a data center aisle

Foundation

Security & trust

Control where Phasis runs, when it updates and how regulated records are protected.

Phasis runs on dedicated infrastructure with a European cloud provider or on a server at your site. You choose the location and agree when updates are installed, keeping production changes under plant control.

Regulated records are never hard-deleted. Approved records lock, and corrections create a new record connected to the original. OEE, safety rates and other controlled calculations are performed consistently by Phasis, with missing inputs shown as blank rather than as a misleading zero.

Company login, permissions and audit history are covered under Access & Audit. Approval authentication is covered under E-signature.

Rows of servers in a data center aisle

Who uses it

  1. IT manager

    Chooses European cloud or on-site deployment and agrees the update schedule.

  2. Quality manager

    Shows how regulated records are withdrawn and how approved evidence is protected.

  3. Validation lead

    Maps the integrity rules into the validated system and the procedures around it.

  4. Plant manager

    Maintains control over data location and production update timing.

Today vs Phasis

  • TodayCorrections overwrite the original regulated entry.
    With PhasisCorrections require a reason and preserve the original record.
  • TodayApproved evidence remains editable after the decision.
    With PhasisApproved records lock, and corrections are recorded separately.
  • TodayControlled calculations are copied into reports from editable files.
    With PhasisPhasis calculates them consistently and shows missing inputs as blank.
  • TodayThe plant has limited control over data location and shared infrastructure.
    With PhasisPhasis runs on dedicated European cloud infrastructure or on site.
  • TodayVendor update schedules can conflict with production priorities.
    With PhasisUpdates are installed at a time agreed with the plant.

The data integrity rules

Seven consistent controls protect regulated records and calculated results across the platform.

  1. 1

    No hard deletes

    A regulated record is never hard-deleted. Each type has a controlled withdrawal path: an NCR is canceled, a certification is revoked with a reason and a reading is voided while the original remains available.

  2. 2

    Approved records lock

    After approval, a calibration, a certificate or a qualification file cannot be edited.

  3. 3

    Corrections are new records

    A correction is recorded separately and linked to the original instead of overwriting it.

  4. 4

    The server computes

    Phasis calculates calibration errors, cleaning limits, chart limits, OEE and safety rates consistently from their recorded inputs.

  5. 5

    Names are frozen

    The person's name is stored with the action, preserving the historical record after their account is disabled.

  6. 6

    Two people, where it matters

    Quality, Calibration, HSE, Permit to Work and Documents prevent self-approval, even when one user holds both operational roles.

  7. 7

    Rates never lie

    Missing exposure hours produce a blank safety rate, and missing cycle time produces a blank OEE. A missing input is never presented as zero.

Where compliance comes from

FDA 21 CFR Part 11 is the US rule for electronic records and signatures in regulated plants. EU GMP (good manufacturing practice) Annex 11 is its European counterpart. Both ask the software for the same three software controls, including signatures, audit history and permission checks. These controls are built into the platform.

Compliance is broader than the software. It depends on the plant's validated system, procedures and regulatory responsibilities. Phasis supplies the applicable software controls and evidence needed to support the customer's validation work.

One thing to plan for when the roles are drawn up: access is granted per module, not per record and not per line. Someone with write on Quality can act on any NCR, not only the ones they raised.

How an update reaches your plant is described on the How we work page.

What you get

  • Consistent data-integrity controls across every module.
  • Named withdrawal paths for regulated records instead of hard deletion.
  • Locked approved records with a clear connection to later corrections.
  • Controlled calculations performed by Phasis from recorded inputs.
  • Dedicated European cloud or on-site deployment.
  • Plant-controlled scheduling for system updates.

Also in the Foundation

Master Data

One shared structure for plants, products, equipment and codes.

Open Master Data

Documents

Controlled documents, approvals and acknowledgement by version.

Open Documents

Numbering

Controlled numbering patterns for every record type.

Open Numbering

Access & Audit

Company login, module permissions and complete audit history.

Open Access & Audit

E-signature

Electronic approvals tied to identity, intent and record state.

Open E-signature

Notifications

Targeted in-app, email, SMS and WhatsApp notifications.

Open Notifications

Integrations & API

A REST API over HTTPS. Dashboards built in. Power BI and other tools can read.

Open Integrations & API

Deployment

Dedicated European cloud or on-site deployment.

Open Deployment

See how Phasis fits your operation.

Tell us which process you want to improve. We will show the relevant workflow using the lines, shifts and decisions your team handles every day.

Book a demo All of Foundation