Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list)

#1
New to the GMP world and thank you for all the helpful discussion treads so far...

Concerning Part11 GMP compliance: We have controlled (signed hardcopies) of our approved supplier list and equipment/calibration list templates (to name a few), but we are using the soft copy excel version as a living document where one person updates as needed whenever we add a new supplier or equipment, etc. We do not print off and sign a new version with each update of this type. Is this in breach of Part 11 compliance? Should we maintain a hard copy version that gets updated and signed off with each addition to be compliant? Thanks you.
 

yodon

Staff member
Super Moderator
#2
This could be quite a can o' worms...

First, why do you think you need to have signed hardcopies of your approved supplier list. (For that matter, why do you think you need to have an approved supplier list at all? There *may* be a requirement - 210/211 isn't my strong suit but you need to base actions on the regulations not some long-standing "we've always done it this way" approach.)

This is probably a bit of a sucker-punch, but how are you ensuring that only approved suppliers are used (obviously not through a signed hardcopy of an approved supplier list).

Part 11 applies to (and I'm quoting from the regulation) "records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations." So first off, you need to realize that if the regulation doesn't require a record, Part 11 doesn't apply. (Well, maybe a little more than that but that's where it starts.) There would be a lot more non-compliance with Part 11 with the process you describe, by the way.

211 does require, for example, a "written record of major equipment cleaning, maintenance ..." If those records are maintained electronically, they should be maintained in compliance with Part 11.

Electronic signatures are somewhat similar.
 

indubioush

Quite Involved in Discussions
#3
I think what Yodon is trying to say is that you need to have the actual records showing the equipment was maintained and that the supplier was approved. I assume you do have supplier evaluation records. If you have this, you can have any method of communicating the list of approved suppliers that is accurate and works for you. Some companies have it just as an electronic file that is viewable by all but editable by Quality, and some have the approved supplier list as a controlled document. As long as you ensure you are only accepting parts/services from approved suppliers, you are fine.
 

QHawk

Starting to get Involved
#4
As far as I know there is NO requirement for a Approved Supplier List (ASL) either in the QSR or ISO. In spite of that most companies maintain an approved supplier list in Excel.

My take is that the ASL should be generated as a report from a validated ERP system. This would provide evidence that the Purchasing controls in your ERP system effectively control the status of your suppliers. Seems simple enough but I have not seen it yet.
 
Thread starter Similar threads Forum Replies Date
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
J Business Intelligence and 21 CFR Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 1
I CAP/CLIA Environment - Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 3
L Implementation of ISO 27001 as part of the GDPR compliance journey Other Medical Device Related Standards 2
I GMP 21 CFR Part 11 Electronic Records Compliance Project Help Qualification and Validation (including 21 CFR Part 11) 9
C ISO 13485 certified as precursor to regulatory compliance to 21 CRF Part 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
I 510(k) Raw Data from Studies - 21 CFR Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 4
Z SAP Validation for Part 11 Compliance - Examples (executed protocols) Qualification and Validation (including 21 CFR Part 11) 3
L Design software for a spectrophotometer for 21 CFR Part 11 compliance Qualification and Validation (including 21 CFR Part 11) 1
Y Part 21-G organization - Compliance documents of received product Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
V Should template/formats be pre configured to claim 21 CFR part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 5
U Compliance with CFR 21 Part 11 vs. ISO 9001 Certification Qualification and Validation (including 21 CFR Part 11) 9
D Compliance to 21 CFR Part 11 Require Registration to FDA? Qualification and Validation (including 21 CFR Part 11) 9
S Documentation needed when changing software due non-compliance of 21 CRF Part 11 Qualification and Validation (including 21 CFR Part 11) 2
G Original Data Copying to Maintain Compliance with 21 CFR Part 820.180 US Food and Drug Administration (FDA) 2
A Compliance with Part ID section of 7.5.3. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C FAA Part 145/M Compliance Checklist EASA and JAA Aviation Standards and Requirements 7
V Exemption of s/w applications from CSV/part 11 compliance Qualification and Validation (including 21 CFR Part 11) 2
C FAA Part 145 Compliance Statement help Federal Aviation Administration (FAA) Standards and Requirements 8
L Compliance to 21 CFR Part 11 - Where to start?? Qualification and Validation (including 21 CFR Part 11) 20
V Configuration changes of s/w and Part 11 compliance Food Safety - ISO 22000, HACCP (21 CFR 120) 1
C Does every PMA part have to have an 8130 form? Or compliance with part 21.303? Federal Aviation Administration (FAA) Standards and Requirements 4
T 21 CFR Part 11 Compliance - Generation of Complete Copies of Records Qualification and Validation (including 21 CFR Part 11) 3
T 21 CFR Part 11 Compliance - Using PDF files as our documentation masters Quality Assurance and Compliance Software Tools and Solutions 3
Q Can I use Cpk to compare if one part is usable in another part? Capability, Accuracy and Stability - Processes, Machines, etc. 5
I PFD (Process Flow Diagram) approach. Setup details as part of PFD? APQP and PPAP 5
B Combat Low Part to Part Variation in GRR Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
C Quality Manager as part of Management - 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
A Complaint review as part of the complaint handling process? ISO 13485:2016 - Medical Device Quality Management Systems 3
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F Physical Part Measurement General Measurement Device and Calibration Topics 6
S Clean room not part of my certification ISO 13485:2016 - Medical Device Quality Management Systems 3
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
J Part submission warrant for Level 1 PPAP APQP and PPAP 1
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
A 60601-1 : Integrated Dry ECG Electrodes = 2 Patient connections inside 1 applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E Zero part to part variation - Gage R&R project Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Separation of F-type applied part and remaining parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
V Part selection for R&R studies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
D Is PMCF really a continuous activity per Annex XIV,Part B? EU Medical Device Regulations 5
M 21 CFR 820 vs 21CFR820 vs 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
N BF-type applied part MOPP vs secondary IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Relabelling a component that will be sold as a spare part - Do I become legal manufacturer? EU Medical Device Regulations 2

Similar threads

Top Bottom