SAP Validation for Part 11 Compliance - Examples (executed protocols)

#1
Hello folks!

Would someone be kind enough to share examples of executed protocols of SAP Validation for part 11 compliance. GAMP5 would be ideal but other will be helpful too.
Thanks
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
You seem to be mixing two concepts - 21 CFR Part 11 is related to Electronic Records and Electronic Signatures, and is different from GAMP requirements.

If you have to review your SAP system to 21 CFR Part 11 requirements, you can tabulate the Part 11 requirements in one column and evaluate each one with what your SAP is designed for.

Did your organization implement SAP on your own or hired SAP consultants?
 

v9991

Trusted Information Resource
#3
Hello folks!

Would someone be kind enough to share examples of executed protocols of SAP Validation for part 11 compliance. GAMP5 would be ideal but other will be helpful too.
Thanks
if i read correctly, that is too much of an ask!
beyond checklists for review of compliance to part-11, nothing specific is accessible for free. and , by any chance, if you have come across any reference-work, do post it back, especially i am eagerly looking for such a state where its accessible for referencE! ( I believe that, such a document by itself is only 1 step beyond a template/format...i.e., an example...because the major work (if not critical) still need to be done specific to your instance)

even if we have access to executed protocols, they have to be atleast re-configured (if not customized/redesign) specific to your instance.
( SAP requires significant amounts of configuration to each client; )

as per GAMP, if you have access to the book/document itself, then it (virtually) provides various templates which can then be implemented.

further, you could find certain usefull references from earlier discussions at end of page....and a quick recap here..viz.,
https://elsmar.com/Forums/showthread.php?t=68271


You seem to be mixing two concepts - 21 CFR Part 11 is related to Electronic Records(ER) and Electronic Signatures(ES), and is different from GAMP requirements.
GAMP is not a requirement right!, it is an (structured)approach towards employing ER/ES in GxP environment as (outlined/defined) per CFR part-11

If you have to review your SAP system to 21 CFR Part 11 requirements, you can tabulate the Part 11 requirements in one column and evaluate each one with what your SAP is designed for.
This step is like, doing gap assessment; I cannot see SAP implementation in manufacturing/distribution environment without overlapping with some GxP requirements. ( in case its not relied upon...thru demonstrating the 'manual - systems/controls' then it is only possible with certain/sure duplication )
the point is, hence it has to go through validation at some detail/extent.
 
Last edited:
#4
Hello and Thank you for your replies both

Ajit,
GAMP is not a requirement its an approach or guidanc er best practise. I have specifically asked for GAMP approach because thats where we are heading as a business. So examples would have helped though I have already started working on it.

21CFR is a FDA requirement (Electronic records and Electrnic signatures) and I know you can have a complete validated system without achieving compliance to Part11. For example...if you are not selling products in US. You would still need to validate the system as per 7.5.2(9001) and 7.5.6 13485 2016 etc.

But if you have to comply with 21CFR you can still use GAMP approach, specify 21CFR in URS or FRS and reference each21CFR against them and Qualify them at OQ and PQ. You can then walk the system upon full validation through 21CFR checklist. I have done that in the past and had no issue, it was audited by FDA. System was called Adaptiv.
My query was related to SAP examples if anyone had them preferabally validated using GAMP approach.

V9999.
Thank you for your links. I already have these at hand...I just needed some SAP examples.
I have started the validation anyway so will share the templates here...SAP is not one of the best ERP when it comes to 21CFR compliance, I must say..and there is very little available free of charge online I agree.
 
#5
Hello ZEE9995,

Is it possible to reach you personally. I'm in the same boat where you were back in 2017. Your expertise will be helpful to me in one my project. Please let me know at your earliest convenience.

Thank you!
Ranjith
 

BradM

Staff member
Admin
#6
Hello there!

Hello ZEE9995,

Is it possible to reach you personally. I'm in the same boat where you were back in 2017. Your expertise will be helpful to me in one my project. Please let me know at your earliest convenience.

Thank you!
Ranjith
The one thing about SAP is how it is designed and developed. I'm not sure an execution protocol from one setup will be of assistance.

Are you utilizing a qualified vendor to develop your SAP implementation? Do they have experience challenging the system to 21 CFR Part 11 requirements?
 
#7
Hello there!



The one thing about SAP is how it is designed and developed. I'm not sure an execution protocol from one setup will be of assistance.

Are you utilizing a qualified vendor to develop your SAP implementation? Do they have experience challenging the system to 21 CFR Part 11 requirements?
Hello, BradM.

No, it's a legacy system, and the company where I was hired had been using SAP B1 for the previous three years with no documentation. They have an off-shore staff that helps with routine production concerns, but they aren't very familiar with US standards, thus it's up to me to validate the system (without any requirements in place). I'm currently familiarizing myself with SAP B1 drafting requirements through the modules that are currently in use,. If someone could guide me on this it's very useful. By the way, I forgot to mention that, my current company supports Non-GxP products and they are in planning in brining up GxP clients in so they want it get validated asap.

Thanks!
 
Thread starter Similar threads Forum Replies Date
R SAP B1 Computer System Validation Qualification and Validation (including 21 CFR Part 11) 0
S What is the clause in ISO 13485 for SAP Software Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
E Computer System Validation - Migrating to SAP Document Control Systems, Procedures, Forms and Templates 5
E Validation of SAP Purchase Order and Sales Order modules Software Quality Assurance 7
ScottK Validation of SAP - Secondary Packaging Manufacturer Qualification and Validation (including 21 CFR Part 11) 8
W Validation of SAP for ERP - Inventory, shipping, and monitoring expiration dates Qualification and Validation (including 21 CFR Part 11) 18
B SAP Audit trail Periodic Review EU Medical Device Regulations 2
R Role of quality compliance in SAP Software Quality Assurance 2
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
chris1price Error in data recording - Recording measurements in SAP Capability, Accuracy and Stability - Processes, Machines, etc. 2
R Wet Signature Document Attachments in SAP - Risk on Data Integrity issue? Records and Data - Quality, Legal and Other Evidence 6
R Regulatory Expectations and SAP US Food and Drug Administration (FDA) 2
S AS9100 Control of Documents and SAP Implementation Document Control Systems, Procedures, Forms and Templates 1
A Can the BOM in SAP be used in lieu of process flow diagram? APQP and PPAP 7
A Supplier Rating from SAP QM Module Data Supplier Quality Assurance and other Supplier Issues 2
C Using SAP for SCAR (Supplier Corrective Action Reports) Quality Assurance and Compliance Software Tools and Solutions 2
A Changes required to procedures after introduction of SAP Document Control Systems, Procedures, Forms and Templates 3
W SAP QM Module - Honest assessment wanted Quality Assurance and Compliance Software Tools and Solutions 11
M Is ERP (Enterprise Resource Plannning) software like SAP in scope of AS9100 7.5.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Implementation of SAP and compliance to ISO 9001: 2008 Document Control Systems, Procedures, Forms and Templates 7
N Procedure and QMS around SAP Document Control Systems, Procedures, Forms and Templates 7
P A SAP DMS Q: Sequantial work flow for DMS review and Approval Document Control Systems, Procedures, Forms and Templates 1
K Part Naming Convention for SAP ERP Application Document Control Systems, Procedures, Forms and Templates 4
S Item Part Code change - New SAP System Document Control Systems, Procedures, Forms and Templates 2
R SAP / EtQ Documentation Systems Document Control Systems, Procedures, Forms and Templates 3
R Vantage/SAP Part Number Nomenclature help Document Control Systems, Procedures, Forms and Templates 1
M Commercial Quality Assurance Software (ie: SAP) vs. Custom Databases Quality Assurance and Compliance Software Tools and Solutions 12
J Relationship Between SAP and ISO9001:2000 Quality Assurance and Compliance Software Tools and Solutions 1
M Lean Manufacturing, SAP and 8.2.4 - No records indicating release of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q SAP ERP Software - do you know anything about it? Quality Assurance and Compliance Software Tools and Solutions 15
A What is the relation between SAP and ISO 9001:2000 documentation requirements? Quality Assurance and Compliance Software Tools and Solutions 3
Marc SAP AG Lawsuit World News 0
L SAP and ISO 9000 - Azerbagampt ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P Test Method Validation (TMV) for all Measurement Methods in Rec/Inspection Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
M Validation of Data verification tool per 21 CFR 820 Quality Assurance and Compliance Software Tools and Solutions 1
G Number of Destructively Tested Devices Needed for Ethylene Oxide Validation Other Medical Device Related Standards 4
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
A GAGE R&R Binomial with master list (for method validation) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
N Validation of special processes - thread closed Oil and Gas Industry Standards and Regulations 3
L Validation without Tolerance Qualification and Validation (including 21 CFR Part 11) 0
shimonv Test Method Validation ISO 13485:2016 - Medical Device Quality Management Systems 10
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Melissa Process Validation of Rotary Heat Sealer Speeds Design and Development of Products and Processes 4
C Validation of process for releasing the UDI EU Medical Device Regulations 4
C Validation of process for production and servicing 5.7.1.5 API Spec Q1, 9th Edition Oil and Gas Industry Standards and Regulations 9
W Transport validation Qualification and Validation (including 21 CFR Part 11) 4
M Is validation required when consumables are changed Qualification and Validation (including 21 CFR Part 11) 7
C 8.3.4 Verification and Validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom