SBS - The Best Value in QMS software

Access to records - Defining who has access to what

D

dbulak

#1
#1
Access to records

I am looking for information (terminology) on how to handle who specifically has access to certain records. For example, certain people have access to some records and some have access to all records. Does this have to be specifically spelled out or are there "general" statements that can be made?

Any help would be appeciated.
 
Free Trial of DISCUS Desktop
Elsmar Forum Sponsor
J

Jim Biz

#2
#2
We use a matrix sheet with the headings
Element/Record number/custodian/indexed by/ accessed by/ stored in (location)/ retained time - legnth / disposition.

The wording in 9000:2000 section 4.2.4 "who has access - but it does state the procedure shahll "define controls needed".

Hope this helps
Regards
Jim
 
E Wall

E Wall

Just Me!
Super Moderator
#3
#3
Originally posted by Jim Biz:
The wording in 9000:2000 section 4.2.4 "who has access - but it does state the procedure shahll "define controls needed".
Click to expand...
Now I'm confused. In Section 4.2.4 of 9001:2000 I do not find any wording or reference regarding 'who has access'.

Unless your management locks you into defining such (and I'd have to ask what benefit would there be?) I would get rid of it.

We also keep a database of what records are kept, as well as identifying who is responsible for collection/retension of these documents. I would be happy to offer a copy of our work instruction. I have no plans of modifying it for 2000 revision.

Using the Auditor Checklist received from our Registrar these are the questions they will be looking for answers on:

1) Have records been established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?
and,
2) Has a documented procedure been established to define the following controls needed?
a. identification?
b. storage?
c. retrieval?
d. protection?
e. retention time?
f. Disposition?

If there is something I am missing please let me know :eek: , I'd hate to be caught unaware.
 
J

Jim Biz

#4
#4
Sorry for the confusion

9001:2000 Does NOT specifically state “Who has access” just that they be controlled
However, implement guide 9004 pg. 3 under 4.2 says Access to docs “Should” be ensured………. based on
Communication policy.

We took a minor hit – on this issue under 1994 version because we had not included “Accessed by.”
In our procedure and had not identified “Who had responsibility for release of doc/data information to customers. (In 4.16 and in 4.11)

Regards
Jim
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Protection of Records from Unauthorized Access or Alteration Records and Data - Quality, Legal and Other Evidence 4
Y ISO: Help With Records Numbering System & Log in Excel or Access Document Control Systems, Procedures, Forms and Templates 12
Q Auditor Access to Records - How far an Auditor can Probe ISO 13485:2016 - Medical Device Quality Management Systems 19
J Retention of Quality Records - NC for "access and disposal of quality records" Records and Data - Quality, Legal and Other Evidence 3
Q FMEA and Risk assessment in Microsoft Access FMEA and Control Plans 6
D Economic Operators, EU Market Access EU Medical Device Regulations 2
Richard Regalado Informational ISO makes available relevant BCMS standards free for online access Business Continuity & Resiliency Planning (BCRP) 6
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
F ISO Certified companies - Is there a list of certified companies that I can access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Security and access in cGMP facilities Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
P Average access height into an industrial machine (average base plate height) Human Factors and Ergonomics in Engineering 2
K EU MDD Class I Device market access / certification after 26th May 2020 EU Medical Device Regulations 9
M Informational Paper on open access – EU postmarket surveillance plans for medical devices Medical Device and FDA Regulations and Standards News 1
R Demonstrate how sufficient levels of access to data is achieved - Claims of equivalence EU Medical Device Regulations 3
M Informational US FDA – Expanded Access for Medical Devices - Investigational medical devices Medical Device and FDA Regulations and Standards News 1
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
J AS9104-1 Clause 18.1 (a) (b) - Organizations (contractor) shall be required to allow access to Tier 2 data AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M Who should have access to Audit trail? Qualification and Validation (including 21 CFR Part 11) 6
A EASA Easy Access Rules for Continuing Airworthiness - June 2017 EASA and JAA Aviation Standards and Requirements 0
M Proposed System: Revision = Modification Date; Approval = Access Permissions Document Control Systems, Procedures, Forms and Templates 1
E Document Control MS Access Database Document Control Systems, Procedures, Forms and Templates 46
R Height gauge to measure short hard to access heights General Measurement Device and Calibration Topics 3
D minitab macro to pull access query with parameters Using Minitab Software 1
I How to build a Microsoft Access MDB Database for Document Control Document Control Systems, Procedures, Forms and Templates 6
P HIPAA Privacy - Login password or USB Access key? Other US Medical Device Regulations 3
N Computer System Access and Security Procedure example wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N Database (Like ASSIST) to subscribe to & have access to new SAE-AS & ANSI standards Various Other Specifications, Standards, and related Requirements 2
L Intellectual Property Protection - Storage, Access, Distribution, etc ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Creative ways to access Expert Information when you can't afford a top $ Consultant Misc. Quality Assurance and Business Systems Related Topics 7
T Microsoft Access Database to create a Simple Calibration Certificate General Measurement Device and Calibration Topics 6
T Basic Document Control Database (Excel/Access) Document Control Systems, Procedures, Forms and Templates 3
A Does anyone use FMEA database in Access? Quality Assurance and Compliance Software Tools and Solutions 2
Marc Archives digitize 19th century materials for 21st century access Coffee Break and Water Cooler Discussions 8
AnaMariaVR2 USP Validation Documents - Free Online Access US Food and Drug Administration (FDA) 1
W User access to all new workmen employees for Training software Design and Development of Products and Processes 2
T Access to a particular Medical Device Electronic Communication Test Port IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Looking for CAPA Database for Access 2003 Quality Assurance and Compliance Software Tools and Solutions 5
P Source Inspection vs. Right of Access clause in a Purchase Order - Differences AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
U PROBLEM: Probability of Resource Access Collision Statistical Analysis Tools, Techniques and SPC 5
A Access Document Control database wanted Document Control Systems, Procedures, Forms and Templates 1
L Access to Hospitals - Vendor (Supplier) Credentialing Misc. Quality Assurance and Business Systems Related Topics 1
Manix Exporting Data from MS Access to MS Word or MS Excel Templates Quality Assurance and Compliance Software Tools and Solutions 5
K I.T. Management in Clause 4.2.3? Control of Computer Data Backup and Access Security ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T How do I control web-based asp forms/rpts that write to and pull from an Access DB Document Control Systems, Procedures, Forms and Templates 4
S Putting Data Macros in a Form Fields - Access 2010 Quality Assurance and Compliance Software Tools and Solutions 5
S Cool Minitab Document 'Sample' - Help with FULL Version location/access? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
T Employee Access to various Documents of our QMS System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Ronen E Eudamed - Public Access - Directive 2007/47/EC preamble EU Medical Device Regulations 2
L Developing an Access ECO Tracking Database - Need help Document Control Systems, Procedures, Forms and Templates 8
A Calibration and PM Access Database Calibration Frequency (Interval) 3

Similar threads

Top Bottom