Pharmaceuticals QMS

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  1. Pharmaceuticals QMS
  2. Data model
Reference

The tables behind Pharmaceuticals QMS

Pharmaceuticals QMS ships with 12 tables, grouped here by the feature that uses them. Every record your team works with lives in one of them, and you can add fields and tables in Proto.

Tables
12
Features
7, plus shared settings
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How the model is organised

Inspection work

Inspections contains the assigned subject; inspection checks stores each observation, result and attachment. Nonconformances links an issue back to the inspection.

Correction

Corrective actions belongs to Nonconformances and has an Owner from People. More than one action can support one issue.

Specialty cases

Out of specification cases and environmental samples each use operational record to reference Inspections.

Audit work

Audit findings belongs to Audits and has an Owner from People; Audits has an Auditor.

Document history

Training acknowledgments links a Person to a controlled documents version.

Identity

People links to Users; assignments and owner checks use those references.

Every table, by feature

Inspections

4 tablesAbout this feature
  • Inspections

    Inspections records for Quality & Compliance (Source).

    Linked to People
  • Inspection checks

    Inspection Checks records for Quality & Compliance (Source).

    Linked to Inspections
  • People

    People records for Quality & Compliance (Source).

    Linked to Users
  • Nonconformances

    Nonconformances records for Quality & Compliance (Source).

    Linked to Inspections

Nonconformances

4 tablesAbout this feature
  • Nonconformances

    Nonconformances records for Quality & Compliance (Source).

    Linked to Inspections
  • Inspections

    Inspections records for Quality & Compliance (Source).

    Linked to People
  • Inspection checks

    Inspection Checks records for Quality & Compliance (Source).

    Linked to Inspections
  • Corrective actions

    Corrective Actions records for Quality & Compliance (Source).

    Linked to Nonconformances, People

Corrective Actions

5 tablesAbout this feature
  • Corrective actions

    Corrective Actions records for Quality & Compliance (Source).

    Linked to Nonconformances, People
  • Nonconformances

    Nonconformances records for Quality & Compliance (Source).

    Linked to Inspections
  • Inspections

    Inspections records for Quality & Compliance (Source).

    Linked to People
  • Inspection checks

    Inspection Checks records for Quality & Compliance (Source).

    Linked to Inspections
  • People

    People records for Quality & Compliance (Source).

    Linked to Users

Out Of Specification

4 tablesAbout this feature
  • Out of specification cases

    Out Of Specification Cases records for Quality & Compliance (Source).

    Linked to Inspections
  • Inspections

    Inspections records for Quality & Compliance (Source).

    Linked to People
  • People

    People records for Quality & Compliance (Source).

    Linked to Users
  • Inspection checks

    Inspection Checks records for Quality & Compliance (Source).

    Linked to Inspections

Environmental Monitoring

4 tablesAbout this feature
  • Environmental samples

    Environmental Samples records for Quality & Compliance (Source).

    Linked to Inspections
  • Inspections

    Inspections records for Quality & Compliance (Source).

    Linked to People
  • People

    People records for Quality & Compliance (Source).

    Linked to Users
  • Nonconformances

    Nonconformances records for Quality & Compliance (Source).

    Linked to Inspections

Audits

5 tablesAbout this feature
  • Audits

    Audits records for Quality & Compliance (Source).

    Linked to People
  • Audit findings

    Audit Findings records for Quality & Compliance (Source).

    Linked to Audits, People
  • People

    People records for Quality & Compliance (Source).

    Linked to Users
  • Controlled documents

    Controlled Documents records for Quality & Compliance (Source).

  • Training acknowledgments

    Training Acknowledgments records for Quality & Compliance (Source).

    Linked to Controlled documents, People

Documents and Training

3 tablesAbout this feature
  • Controlled documents

    Controlled Documents records for Quality & Compliance (Source).

  • Training acknowledgments

    Training Acknowledgments records for Quality & Compliance (Source).

    Linked to Controlled documents, People
  • People

    People records for Quality & Compliance (Source).

    Linked to Users

Shared and settings

1 table
  • Users

    Users

    Linked to Users

Keys and references

Keep the original source identifier for each migrated record so links can be reconciled. Inspection number and audit number help operators find cases, while the references join the records. Match a person to the right Users account before importing assigned inspections, actions or findings. Check document version identity before importing acknowledgments. The exact fields and select values appear below.

Migration order

  1. Import Users and People; verify the People.User references.
  2. Import controlled documents and Audits, then training acknowledgments and audit findings.
  3. Import Inspections and their assigned People links.
  4. Import inspection checks, environmental samples, out of specification cases and Nonconformances with their Inspection references.
  5. Import corrective actions after their Nonconformances and Owners are available.
  6. Reconcile samples, cases and findings against source identifiers before the first operating cycle.

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