Electronic Record Control (Specifically editable records not fixed documents!)

P

pmgeens

#1
Greetings all! I have been using this site as a resource for over a year now and have found solutions and suggestions to dozens of problems. What an amazing collection of ISO information! :applause:

I am now facing a very specific problem and it hasn't quite been answered despite several days of searching through various SharePoint and wiki threads.

Basically, I am about to deploy a SharePoint document management system and as far as "fixed" document issuing and approval go I'm happy that the workflows satisfy the ISO standard. As I am the only person who can upload documents to SharePoint (with a password required to login), I am happy that I can demonstrate absolute control over the master set of documents and blank record sheets. However I am looking for advice regarding editable record sheets after their distribution to end users via SharePoint.

For example, an employee has access via SharePoint to their own training record sheet which is approved and is on version 1. This is a record sheet that will need to be filled out time and time again (whilst remaining on version 1), requiring the signature of both the employee and their supervisor each time a new skill is added. How can I demonstrate to an auditor that the signatures have genuinely been individually signed by both of these different people each time the record sheet is updated? I'd rather not go down the digital signature route if possible. I hope this scenario makes sense!

Any suggestions would be greatfully received!
 
Elsmar Forum Sponsor
R

Rickser

#3
When you figure this out, let me know. I've been searching for a way to have employees digitally sign in SharePoint for a while now. I want them to sign that they have read certian HR documents as well. My IT person left before she got it done. Now I'm stuck.
 
N

nicole_i

#5
Could you not just have a date of signature inserted into the record sheet, one for the employee and one for the supervisor?
I have a similar problem with showing that training has been delivered but I enter a signature date and then back up this up with an email filled in a public folder within outlook.
If the auditor wanted evidence that both supervisor and employee had signed and dated the record he would ask them for confirmation, they surely would have some evidence that a particular skill had been achieved.
The standard asks us to control records that have been established to provide evidence of conformity and that is what you are doing – you are controlling the record.
Sorry if I have misunderstood :)
 

v9991

Trusted Information Resource
#6
I am not that familiar with sharepoint......Within purview of certain assumptions here's few thoughts..
First, its 'revision no.' of training record which is controlled through doc-control; each update of it with each trainee has to be versioned!!! (typically whenever an update wrt completion of training or even endorsement of supervisor they ought to be versioned)

second, I assume that trainee & supervisor are separately(electronically) updating the training record. so solution could be that
ensure that training record is not released untill the supervior has signed off.

however, it would help if you could provide few more details...
1) the workflow steps for a person to update/add the skill to the training record sheet.
2) also, what do you mean by "
requiring the signature of both the employee and their supervisor each time a new skill is added.
" does it mean that trainee & supervisor update the record(line item with their signatures) and upload it to sharepoint?)
 
P

pmgeens

#7
Thank you for your replies.

Firstly, Nicole, the training record does have a date for each new signature entry but the same problem applies in that what is to stop the employee filling out both signatures and dating them?

I take your point that there may be evidence elsewhere to back this up but I am hoping to find a more elegant solution where all the info is contained on one record sheet within SharePoint.

v9991, I'm not sure about your first point. The training record sheet I describe is a working record for an individual trainee. The record is updated everytime they add a new skill so the version number doesn't change with each new skill added.

In answer to your second point, each employee has a "general training record" released to them (on version 1 for example) which starts off blank and resides in their own records folder on SharePoint.

Each time they demonstrate competence in a new task, a new line is filled out referencing the work instruction for said task followed by the electronic signature of the employee and supervisor (with date) to verify that the employee is competent in that task. The record then remains in their folder until the next task is added further down the line.

I'm probably trying to simplify something that can't be simplified but thought somebody may have had similar problems, particularly with SharePoint.

The problem with SharePoints versioning system is that once the record sheet is issued, I don't want a new version everytime the record is updated as a working record. I hope that makes sense, its tricky to explain!

I really appreciate everybodies input, I know this is a vague problem at best!
 

Mikishots

Trusted Information Resource
#8
Greetings all! I have been using this site as a resource for over a year now and have found solutions and suggestions to dozens of problems. What an amazing collection of ISO information! :applause:

I am now facing a very specific problem and it hasn't quite been answered despite several days of searching through various SharePoint and wiki threads.

Basically, I am about to deploy a SharePoint document management system and as far as "fixed" document issuing and approval go I'm happy that the workflows satisfy the ISO standard. As I am the only person who can upload documents to SharePoint (with a password required to login), I am happy that I can demonstrate absolute control over the master set of documents and blank record sheets. However I am looking for advice regarding editable record sheets after their distribution to end users via SharePoint.

For example, an employee has access via SharePoint to their own training record sheet which is approved and is on version 1. This is a record sheet that will need to be filled out time and time again (whilst remaining on version 1), requiring the signature of both the employee and their supervisor each time a new skill is added. How can I demonstrate to an auditor that the signatures have genuinely been individually signed by both of these different people each time the record sheet is updated? I'd rather not go down the digital signature route if possible. I hope this scenario makes sense!

Any suggestions would be greatfully received!
What is it about digital signatures that you don't like? The latest version of Adobe Reader has this integrated and is extremely quick to use. We have 600 employees and it was very quick and simple to set up.
 
Thread starter Similar threads Forum Replies Date
D How to approach Paper and Electronic Record Control for ISO 9001:2008 Records and Data - Quality, Legal and Other Evidence 7
J Electronic Device History Record (eDHR) Software Recommendations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Electronic Record Retention per FDA Requirements - Electronic Data Capture (EDC) Records and Data - Quality, Legal and Other Evidence 4
B Electronic Record File Format (Pdf & Tiff) - Acceptance by FDA? Qualification and Validation (including 21 CFR Part 11) 4
R Electronic Training Record Form (Template) Document Control Systems, Procedures, Forms and Templates 6
D Transferring Paper Records to Electronic Record Archival Records and Data - Quality, Legal and Other Evidence 4
sagai Automated System's Signature on Electronic Record - PART11 Qualification and Validation (including 21 CFR Part 11) 4
W Physician Documentation System vs. Electronic Medical Record 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Transition to Electronic Paperless System - How is Record Retention Addressed Records and Data - Quality, Legal and Other Evidence 11
D Advice on capturing electronic signatures ISO 13485:2016 - Medical Device Quality Management Systems 8
C Shelf life electronic components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Cleaning of electronic transmitter Other Medical Device Related Standards 2
D Preservation of Electronic Data / Information Technology ISO 13485:2016 - Medical Device Quality Management Systems 5
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
R Electronic and hand-written footnotes for GDP Document Control Systems, Procedures, Forms and Templates 1
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J Integrity of electronic digital records - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
T Electronic ECO/ECR Process - Software recommendations Document Control Systems, Procedures, Forms and Templates 3
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
D Benefits of electronic QMS software Software Quality Assurance 5
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
R Electronic handwritten signatures for approvals - Signed with a Stylus or a Finger Document Control Systems, Procedures, Forms and Templates 2
WEAVER Electronic Weighing Scale Calibration Tolerance Manufacturing and Related Processes 1
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
P FDA inspections and electronic signatures Other US Medical Device Regulations 2
S Need Assistance in Visual Inspection - Tiny electronic components AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Looking to move to an electronic QMS software Software Quality Assurance 11
QIE Electronic IFU - new project, need input Other Medical Device and Orthopedic Related Topics 0
U Electronic templates for making paper control charts Reliability Analysis - Predictions, Testing and Standards 2
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
P Electronic component failure analysis turnaround time Reliability Analysis - Predictions, Testing and Standards 0
W Part Change Request - Standard (OTS) electronic parts (resistors, capacitors etc.) IATF 16949 - Automotive Quality Systems Standard 3
C In cases where users of an electronic system change their names Qualification and Validation (including 21 CFR Part 11) 6
A How a test flow can be build for a car electronic sunroof control Reliability Analysis - Predictions, Testing and Standards 6
M Electronic signature - name.lastname or equal to handwritten Document Control Systems, Procedures, Forms and Templates 3
N Electronic Instructions for use (eIFU) EU Medical Device Regulations 1
M Electronic Signature - Certificate Qualification and Validation (including 21 CFR Part 11) 8
I GMP 21 CFR Part 11 Electronic Records Compliance Project Help Qualification and Validation (including 21 CFR Part 11) 9
M Medical Device News FDA News - 12-09-18 - MD Submissions to Electronic Format to Improve Efficiency Other US Medical Device Regulations 0
Q Real Time Electronic SPC/Control Charting Statistical Analysis Tools, Techniques and SPC 4
M Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant) Qualification and Validation (including 21 CFR Part 11) 12
L Inspection Process for Electronic Parts from Brokers Supplier Quality Assurance and other Supplier Issues 1
N How is documentation affected moving to an electronic system? ISO 13485:2016 - Medical Device Quality Management Systems 13
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
W ISO 14155 - Electronic clinical data systems - Definition Other Medical Device Related Standards 0
D 21 CFR Part 11 - Electronic Signature Management SOP Other US Medical Device Regulations 0
G Auto electronic signature on Calibration Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom