Updating Technical Documentation regularly => Leaner Release Advice

Auxilium

Involved In Discussions
#1
Hello all, we are a company that develops SaMD and currently, we are using Google Drive and hence, our Technical Documentation basically consists of a bunch of Google Docs that we copy and update where necessary (depending on the change itself).
For every product update, we check all documents in our Technical Documentation and assess whether there is a change.
Especially in a fast-paced environment, it is crucial to be able to release let's say once per week and to have our documentation up to date.

The problem we want to solve is speeding up the release process while being regulatory compliant. We already asked ourselves whether we can just draw up our Technical Documentation after release but that would be not possible.
Can you recommend any useful tools for this process that would enable us to speed up our release process when let's say all the development and implementation is done but we can't release yet because our Technical Documentation is not ready yet? This costs us too much time!
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
Are your users happy with such frequent changes?

What, actually, is bogging down the release process? What documents are you needing to update and why does it take so long?
 

Auxilium

Involved In Discussions
#3
Hello yodon, I think one of the biggest bottlenecks we have in our current release process is the Testing of our product which we plan to reduce. The general approach in the future will be: test less and do regression testing as mentioned in some other thread of me.

1) Yes, we are currently doing frequent changes and cover them as hot fixing issues with less documentation but we cannot pursue this approach in longterm.
That said, we need something that enables us to do frequent changes with a significant speed-up in our documentation release.
2) We review all of our documents in our TD whether they need an update and then kind of release them again with signatures. Unchanged documents, we take the old ones that are already released.
3) It takes long partly because getting people to review and then sign the documents is time-consuming.

Do you know any tools or solution that could help us with in problem? is there any big potential at all to improve our release process?
 
Thread starter Similar threads Forum Replies Date
Al Rosen Technical File - Updating Applied Standards EU Medical Device Regulations 4
S Requirements for Updating a Medical Device Technical File EU Medical Device Regulations 13
G Updating MDD devices after MDR transitional period EU Medical Device Regulations 0
G Updating FMEAs after Design Updates FMEA and Control Plans 4
T Help with updating procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
T Re-PPAP after updating CMM program? Manufacturing and Related Processes 9
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
H Updating Quality Manual to API Q1 Service Industry Specific Topics 6
Z Minitab - Updating Graph with specific data points Using Minitab Software 2
N Updating the website of the manufacturer EU Medical Device Regulations 1
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
N Updating QM to 13485:2016 - We do not make medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
B Site Move - Question about Updating Product Labels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
O Updating "opportunities" resulting from Corrective Actions Nonconformance and Corrective Action 2
N Updating class I device IFU with instructions to use class II cleared device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Periodic review criteria for reviewing/updating SOPs US Food and Drug Administration (FDA) 1
T Design Changes - Updating the Design and Development File EU Medical Device Regulations 5
L Clinical Evaluation Report Updating Procedure Other Medical Device Related Standards 5
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M AS9100D - Updating Scope Exclusions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W ISO9001:2015 - Clause 7.5.2 - Requirements for Creating & Updating Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Actions Taken - Updating a FMEA for the addition of a downstream poke yoke FMEA and Control Plans 3
I NCR for Customer not updating their drawings AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
P Updating a Medical Device's Intended Use Other US Medical Device Regulations 2
N Updating Job Titles - Does This Mean There Needs to Be a rev change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
shimonv Updating Safety Test Report when changing component supplier IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Updating Outdated Calibration Procedures Document Control Systems, Procedures, Forms and Templates 2
J Is the SFDA in China in the process of updating their Medical Device Regulations ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design & Development in Updating Machines and Equipment - ISO 9001 Help Design and Development of Products and Processes 4
F Updating a Quality Manual from ISO 9001 to ISO TS 16949 - Process Mapping IATF 16949 - Automotive Quality Systems Standard 2
B Requirement for Updating Medical Device Software (Firmware) in the Field 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
S IPC 620 updating from Class 1 to Class 3 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Updating (Revising) Documents with a New Logo Document Control Systems, Procedures, Forms and Templates 3
O Sum of Cpk - Updating Product Tolerances Capability, Accuracy and Stability - Processes, Machines, etc. 6
M Updating a Quality Manual from ISO 9001:2000 to ISO 9001:2008 Quality Management System (QMS) Manuals 57
B Updating from ISO 9001:2000 to ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R Standard Relevance & Updating - ASME B&PVC Various Other Specifications, Standards, and related Requirements 4
T Updating to ISO 9001:2008 - I need to add section 7.3 Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
J Declaration of Conformity - Updating the DofC to MMD 2007/47/EC EU Medical Device Regulations 4
C Updating our Laboratory Calibration / Verification Procedures IATF 16949 - Automotive Quality Systems Standard 5
J ISO/AS Surveillance Audit - Minor for not updating my QA Manual to ISO 9001:2008 Quality Management System (QMS) Manuals 95
V Updating Quality Manual - Adding the word Statutory in front of laws and regulations Quality Management System (QMS) Manuals 3
M Updating Certificate of Foreign Government (CFG's) Other US Medical Device Regulations 18
ScottK How is this for extremes in updating to the ISO9001:2008 rev ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
I Updating Lead Auditor Certifications to ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A FDA - Registration & Listing Updating + when Purchasing another Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
K Updating Procedures because they are bland and wordy Document Control Systems, Procedures, Forms and Templates 12
C Updating the IPC1752 info RoHS, REACH, ELV, IMDS and Restricted Substances 3
W Standards Updating Service? Current Revision Level of Standards Other ISO and International Standards and European Regulations 11

Similar threads

Top Bottom