SIRIAMLAB

Module 06

Documentation.

The controlled document set of the SIRIAM Scientific Quality Management System. Every record originates from the source documentation; these pages are documentation, not presentation.

Chapter

Production chapters

Narrative chapters of the standardisation and production document, transcribed from the source.

  1. Chapter-20Chapter 20 — Clinical Implementation of the SIRIAM PlatformDocumented
  2. Chapter-21Chapter 21 — Scientific Validation & Future DevelopmentDocumented

Template

Product Formula records (PF)

One controlled master formula record per product phase: composition, manufacturing workflow, quality control and batch release.

  1. PF-001AOAA DUO Phase 1 Master FormulaDocumented
  2. PF-002AOAA DUO Phase 2 Master FormulaDocumented
  3. PF-003APHRENIC DUO Phase 1 Master FormulaDocumented
  4. PF-004APHRENIC DUO Phase 2 Master FormulaDocumented
  5. PF-005ACTO DUO Phase 1 Master FormulaDocumented
  6. PF-006ACTO DUO Phase 2 Master FormulaDocumented
  7. PF-007APLEXUS SOLARIS Phase 1 Master FormulaDocumented
  8. PF-008APLEXUS SOLARIS Phase 2 Master FormulaDocumented
  9. PF-009APLEXUS BRACHIALIS Phase 1 Master FormulaDocumented
  10. PF-010APLEXUS BRACHIALIS Phase 2 Master FormulaDocumented
  11. PF-011ATLO DUO Phase 1 Master FormulaDocumented
  12. PF-012ATLO DUO Phase 2 Master FormulaDocumented
  13. PF-013APLEXUS LUMBALIS Phase 1 Master FormulaDocumented
  14. PF-014APLEXUS LUMBALIS Phase 2 Master FormulaDocumented
  15. PF-015APLEXUS LUMBOSACRALIS Phase 1 Master FormulaDocumented
  16. PF-016APLEXUS LUMBOSACRALIS Phase 2 Master FormulaDocumented
  17. PF-017ASX DUO Phase 1 Master FormulaDocumented
  18. PF-018ASX DUO Phase 2 Master FormulaDocumented
  19. PF-019AKORR Master FormulaDocumented
  20. PF-020AInflammaSacra I Master FormulaDocumented
  21. PF-021AInflammaSacra II Master FormulaDocumented
  22. PF-022AInflammaSacra III Master FormulaDocumented

RM

Reference manuals (RM)

The reference layer of the quality system. Registers whose structure is defined but whose entries are not yet released are marked Content Pending.

  1. RM-001RM-001Content pending
  2. RM-002RM-002Content pending
  3. RM-003Approved Material RegisterContent pending
  4. RM-004Purchasing & Inventory RegisterContent pending
  5. RM-005Manufacturing & Batch RecordContent pending
  6. RM-006RM-006Content pending
  7. RM-007RM-007Content pending
  8. RM-008RM-008Content pending
  9. RM-009RM-009Content pending
  10. RM-010RM-010Content pending

SOP

Standard operating procedures (SOP)

How recurring work is performed and recorded.

  1. SOP-001Digital Standard Operating Procedure: OAA DUOContent pending
  2. SOP-002SOP-002Content pending
  3. SOP-003SOP-003Content pending
  4. SOP-004SOP-004Content pending
  5. SOP-005SOP-005Content pending
  6. SOP-006SOP-006Content pending
  7. SOP-007SOP-007Content pending
  8. SOP-008SOP-008Content pending

Appendix

Appendices

Supporting tables, templates and indices.

  1. Appendix-AAppendix AContent pending
  2. Appendix-BAppendix BContent pending
  3. Appendix-CAppendix CContent pending
  4. Appendix-DAppendix DContent pending
  5. Appendix-EAppendix EContent pending
  6. Appendix-FAppendix FContent pending
  7. Appendix-GAppendix GContent pending
  8. Appendix-HAppendix HContent pending
  9. Appendix-IAppendix IContent pending
  10. Appendix-JAppendix JContent pending

Architecture

Reserved modules

Declared in the architecture so navigation and data structures can accommodate them. None of these modules is implemented.

Reference manuals

Extended manual set beyond the current controlled documents.

Reserved

Manufacturing

Production records and process documentation.

Reserved

Quality assurance

Release checks, deviations and CAPA.

Reserved

Inventory

Materials, stock positions and expiry tracking.

Reserved

Clinical outcomes

Structured observation framework for practitioners.

Reserved

Supplier management

Qualification and review of suppliers.

Reserved

Batch records

Batch identity linked to the QR resource of a record.

Reserved