Writing Reports - Releasing Data into our Documentation System

#1
Maybe someone might be able to provide some guidance on a hotly debated issue at my (med device) company.

We currently have two paths that one can go down when releasing data into our documentation system.

One path is using a protocol and report. The protocol contains the purpose of the study, the instructions, and acceptance criteria. All of this is approved and the protocol is released into our documentation system the study is conducted. The results and any deviations to the study as well as rationale for acceptance is contained in the report which is again approved and released into our documentation system.

The second path is to release a technical report. The technical report may contain all the same information, but it is released in one large document, similar to how you might write up a lab report in school.

Everyone agrees that for any testing that needs to be submitted to a regulatory body needs a protocol and report, but beyond that, the agreement breaks down. Does anyone have some general rules that you follow to determine if one or the other might be necessary?
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Well, this has been sitting around unanswered too long. I'll stick my neck out.

I'm in medical devices and so this is certainly slanted to that field.

I re-looked at 21 CFR 820 (US FDA regulations) and ISO 13485 (international standard) and didn't see anything that required a particular approach. I have always taken the protocol - report route so I dug a bit deeper. In the FDA guide to auditing (QSIT - https://www.fda.gov/downloads/iceci/inspections/ucm142981.pdf) they get a bit closer, noting:

Confirm that acceptance criteria were established prior to the performance of verification and validation activities.

So I guess from a medical device perspective, if you take the report approach, as long as your plan (or some other mechanism) establishes the acceptance criteria, this would be acceptable.

Again, this is strictly speaking for medical devices and your industry may be different. It would point to good practice, though (otherwise, you can craft the report to match your actual results).
 
Thread starter Similar threads Forum Replies Date
B Writing Techniques for Audit Findings, Reports, etc. Internal Auditing 15
M One weakness of audit non-conformance reports is the poor writing Miscellaneous Environmental Standards and EMS Related Discussions 10
W Writing Reports - Giving detailed information on a Continuous Improvement Project Quality Tools, Improvement and Analysis 2
Z Who is responsible for writing the validation of a new process? Manufacturing and Related Processes 7
S IAQG guidelines for AS9100 report writing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L Is writing out the ISO9001:2015 standard full name a requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
I Writing a Cosmetic Criteria for Switches Document Control Systems, Procedures, Forms and Templates 1
N GDP - Having to provide a reason when writing N/A? ISO 13485:2016 - Medical Device Quality Management Systems 1
R MDR 745/2017 keynote - I'm a student and I'm writing a thesis EU Medical Device Regulations 4
P Secretly Auditing - Writing an audit report with observations based on my experiences Internal Auditing 12
V Writing a Pre-Submission to the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 44
A Self-study plan to improve fluency in English speaking, writing After Work and Weekend Discussion Topics 3
A Audit report writing course - Suggestions wanted Internal Auditing 9
J Required on-site training on writing deviations & root-cause analysis Training - Internal, External, Online and Distance Learning 3
dubrizo Audit Findings: Writing against Internal an ISO Clause Internal Auditing 10
A Writing an Internal Audit Report Finding for Employee Awareness of QMS Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Writing appropriate ISO 13485 Audit Report Findings Internal Auditing 15
J Technical Writing - Help Training Supervisors in the Basics Training - Internal, External, Online and Distance Learning 6
Pancho Writing, it is. How's this related to quality? The Reading Room 6
K Process Writing Software Suggestions for Internal Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Struggling With Writing PA (Preventive Action) Procedure Preventive Action and Continuous Improvement 11
x-files Procedure writing - Section - Related documents Document Control Systems, Procedures, Forms and Templates 8
S Brazilian Standard Compliance for Writing Instruments - Inmetro RoHS, REACH, ELV, IMDS and Restricted Substances 2
insect warfare Guidance on Writing in Plain English Quality Tools, Improvement and Analysis 24
C Writing a Sterilization Procedure when the Process is Subcontracted - ISO13485 Quality Management System (QMS) Manuals 1
C Writing Quality Management Plans for a Tender Submission Quality Manager and Management Related Issues 4
M Writing a Manufacturing Recall Procedure Document Control Systems, Procedures, Forms and Templates 3
M Writing a Minitab macro that can manipulate data in all columns Using Minitab Software 3
H Writing a Product Label Inspection Work Instruction Manufacturing and Related Processes 2
D Writing Minutes (Records) from Management Review Meetings Quality Manager and Management Related Issues 11
V Where to add SOP of writing a Technical File in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
B Seeking help in writing marketing message Career and Occupation Discussions 12
G Writing up BRC audit non-conformance Internal Auditing 9
A Writing a Procedure for Validation of an Analytical Method General Measurement Device and Calibration Topics 5
AnaMariaVR2 Free Online 'Writing in the Sciences' Course Training - Internal, External, Online and Distance Learning 2
B Seeking help in writing an audit report that can stand on the court Internal Auditing 6
T Generic Guides for Procedure Writing Document Control Systems, Procedures, Forms and Templates 20
B Developing a Queue Management Procedure - Need some help writing a Proposal Quality Manager and Management Related Issues 2
Miner Writing Minitab Macros Using Minitab Software 6
N Writing our Standard Operating Procedures for Dietary Supplement Co - Examples wanted Document Control Systems, Procedures, Forms and Templates 7
B Writing a Customer Survey......Any tips? Customer Complaints 13
S Writing a Test Method Validation Procedure as well as Validation of Test Methods General Measurement Device and Calibration Topics 1
Moncia Writing a new Quality Manual for my new company - Need help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Having trouble writing a directive (procedure) that points to the right place ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
C NON-ISO Laboratory Scope Writing (for the Fire Marshal) Design and Development of Products and Processes 3
F Starting a Quality Control Program and writing a Quality Control Manual Quality Manager and Management Related Issues 10
sagai What is CD writing considered as - for Device-Only SW? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
AnaMariaVR2 [White Paper] Writing & Enforcing Your SOPs for GxP Compliance Success Document Control Systems, Procedures, Forms and Templates 0
S HACCP for Animal Feed - Writing a form and report about Animal Feed Food Safety - ISO 22000, HACCP (21 CFR 120) 10
J Acceptable Tolerance Range for Freezer - Writing an IQ/OQ for a Freezer US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom