Brief

We (BiomeBank) are in the process of identifying an eQMS system and

transitioning our QMS from paper to digital. For this challenge, we’d
appreciate seeing how you would attack this assignment, from sourcing
through implementation and validation – with costs, efficiency, and
obtaining “team buy in” as key requirements.
Is there available eQMS in Market?

Quick internet search; more than 20

off the shelf eQMS focused on
Pharma/Biotech/ Med Devices
Industries.

From Where to Start?

 Planning; Brain Storming
Risk
Management
Process Quality
TGO
107
Process Integrations? TGO Australian
Specificities? 105 Code of
Data
GMP
Management
Data Integrity

Product Safety
Safety
Product Code?
Specificities?
Regulatory Business Strategic
Growth

Regulatory Budget / GO Live User

Class Regulatory User Running date? Friendly
Commitments? Cost
Requirements
Confirm
Scope

Must to Nice to
have have
Planning; Corse Screening

• Bench Marking (Check with connections in other Pharma/Bio

companies on eQMS)

• Study Software Review Sites (e.g. Capterra, GetApp, etc.)

• Connect with focused technical forums (e.g. LinkedIn Groups)

20+
options

3
options
Planning; Fine Screening
• User Requirements Specification Vendor communication

• Request for Quotation

• Vendor Assessment / Functional Requirements Specification

• Quote Review / Deployment Plan Review

• Business Award (Gate Decision)

Deployment
• System Installation / Qualification Package

• Access Management / Computer System Validation

• End User Training

• Testing / Data migration

• SOP update

• Go Live (Gate Decision)

• Communication
Review
• Backup / Restoration

• Disaster Recovery Planning

• Vendor Management

• Periodic System Review

Backup Slides
Avoiding Common eQMS Implementation
Project Pitfalls: A Must-Read Guide
• Pitfall 1: Deliberately or accidentally not involving the end users in the
process
• Pitfall 2: Lacking People Change Management
• Pitfall 3: Business requirements are not properly translated into a User
Requirements Specification
• Pitfall 4: A vaguely defined scope with room for interpretation
• Pitfall 5: Choosing the wrong vendor because of unclearly defined
requirements

https://www.linkedin.com/pulse/avoiding-common-eqms-implementation-p
roject-pitfalls-guide-van-gorp%3FtrackingId=5abQkOiLR5aH1YXzw0%252BQ
%252BQ%253D%253D/?trackingId=5abQkOiLR5aH1YXzw0%2BQ%2BQ%3D%
eQMS websites
1. https://www.qualio.com/
2. https://www.arenasolutions.com/
3. https://www.simplerqms.com/quality-management-system/ Starts at $1,150/month (5-10 Users)
4. https://www.dotcompliance.com/ (QMS Xpress, Compliance Xpand, Enterprise Xact)
5. https://www.qualityze.com/
6. https://www.mastercontrol.com/au/quality/qms/
7. https://www.etq.com/platform/
8. https://www.greenlight.guru/
9. https://www.spartasystems.com/trackwise/
10. https://www.zenqms.com/why-zenqms
11. https://qt9qms.com/quality-management-software
12. https://pscsoftware.com/software/ace/
13. https://www.compliancequest.com/
14. https://www.momentumsystems.com.au/open-source-quality-management-software/?utm_source=GetApp
15. https://proshoperp.com/quality-management/?source=GetApp
16. https://amplelogic.com/
17. https://softcomply.com/product/eqms/
18. https://www.ceieu.com/en/software-eqms-qms-gestion-calidad-gestion-documental-sharepoint/
19. https://almond-qms.com/
20. https://www.freeqms.com/
Faecal microbiota transplant (FMT) products Interpretative
and technical guidance on GMP requirements
For Class 2 biologicals (or greater) Section 1000 of the Australian Code of GMP applies for Class 2 biologicals (or
greater).

Validation and control of computerised systems

The level, extent and formality of system control should be commensurate with the criticality of the system.
Manufacturers should have a good understanding of all the systems used, along with the impact and criticality
of each system. Examples of systems that should be fully validated and controlled include, but are not limited
to:
for the electronic acquisition of QC data
to control and monitor the operation of critical utilities, facilities and equipment
to generate, store or access electronic GMP records
to generate, process, calculate or monitor data that forms part of the batch processing record, or batch control
testing records
electronic spreadsheets to track records or data, or to perform calculations, in the place of physical (hard-copy)
records
to perform the release of materials and release for supply of finished goods
to track the distribution of products and/or control the reconciliation of products and materials in the case of
quality defects or recalls
to manage quality investigations and store and track investigation records, for example deviations, out of
specifications, complaints and change control.
Australian code of good manufacturing practice for human
blood and blood components, human tissues and human
cellular therapy products
Computers
Principle:
1000. The introduction of computerised systems does not alter the need to observe
the relevant principles given elsewhere in the Code. Where a computerised system
is implemented, there should be no adverse affect on product quality and safety, or
security and integrity of data.