Controlling software and Data - Control of Information maintained in computers

D

Dawn

#1
#1
I have been told by the auditor that if we have information maintained in computers how is it controlled? We have work instructions for backing up the computers. Do we need anything else? (Lost)
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
R

Roger Eastin

#2
#2
Are your electronic information, records or documents (level 3)? You probably need to supply some more details as to what kind of information you are talking about. If it is level 3 information, then standard control procedures must be followed per Element 4.5. However, if the information is records then it must follow your procedure for quality records. The type of media that you use, whether paper or electronic, has to follow your standard procedures. Now, if you are talking about software that is used in some sort of process (NC machines, maintaining quaity records with some sort of database, etc.), then you, as you have stated, have to provide a system for backing up this software on a regular basis.
 
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
#3
Now, if you are talking about software that is used in somesort of process (NC machines, maintaining quaity records with some sort of database, etc.
Click to expand...
How about Change History?
 
R

Roger Eastin

#4
#4
Are you referring to the Change History of the software itself or of the data that the software uses? Most times the change history of the former case is maintained by the folks who wrote the software and I suppose that access to that history may be needed, for instance, to determine if a company needs to upgrade that software. If you mean the latter case, then I agree that a change history is needed (per 4.5) by the company inputting the data.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Controlling Software Versions that are part of a medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
T Procedure for "Controlling Nonconformity" for a software company Document Control Systems, Procedures, Forms and Templates 2
J Software change control - How should I be controlling software changes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Seeking Advice - Effective QMS Software for Controlling Audits, Documents etc.? Quality Assurance and Compliance Software Tools and Solutions 19
R Controlling Quick Reaction Checklists Document Control Systems, Procedures, Forms and Templates 1
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
qualprod Controlling documents in two different Applications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M AS9100d Controlling External Provided Processes (purchasing 8.4) - The customer want us to use supplier X AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
qualprod Minor non-conformance for not controlling local regulation laws? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
QSM_Rick Controlling Multi-Tab Microsoft Excel Forms Excel .xls Spreadsheet Templates and Tools 5
A ISO 13485 - Controlling Production and Service Provision - Product Catalogues ISO 13485:2016 - Medical Device Quality Management Systems 3
M Difficulties Controlling Foreign Suppliers Supplier Quality Assurance and other Supplier Issues 8
R OHSAS 18001:2007 Section 3 - Controlling Work Place Risks Occupational Health & Safety Management Standards 3
T Controlling an Excel Spreadsheet (Database) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9001:2008 4.2.3(f) - Controlling Documents of External Origin Quality Manager and Management Related Issues 9
M Controlling Flow Charts that are hung in workplace. Quality Manager and Management Related Issues 6
N Controlling Records query that may cause some serious trouble for me ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Controlling Manual - Control of 10 Printed Manuals throughout our 9 Branches Document Control Systems, Procedures, Forms and Templates 8
Fender1 Controlling Documents and Records in a Custom Weld/Fabrication Company Document Control Systems, Procedures, Forms and Templates 10
C Tool Monitoring - Controlling a Process with Better Tool Monitoring Manufacturing and Related Processes 4
C Controlling QMS - We are expanding globally and want to keep our QMS Confidential Quality Manager and Management Related Issues 20
C Controlling Documents: Beyond the standard, how do we truly define what to control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R Referencing and Controlling Labels & Stickers used internally throughout Production Document Control Systems, Procedures, Forms and Templates 1
Q Controlling Prints in Shop - Audit Finding Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Controlling "Stamps" used throughout our processing Records and Data - Quality, Legal and Other Evidence 16
T Requirements - Controlling and Maintaining Sheet Metal Templates for Production Use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Controlling Solidworks model, CAD & Gerber files Document Control Systems, Procedures, Forms and Templates 3
M Defining and Controlling External Documents (Documents of External Origin) Quality Tools, Improvement and Analysis 5
M Controlling Temperature and Time - Do I need to calibrate the thermostat? IATF 16949 - Automotive Quality Systems Standard 4
S Controlling Documentation - Which procedures to control Document Control Systems, Procedures, Forms and Templates 12
C HACCP in Egg Production - Controlling hazards at the farm level Food Safety - ISO 22000, HACCP (21 CFR 120) 6
M Controlling Data Labels on Graphs - Number of Decimal Places Reported - Minitab Using Minitab Software 7
I Controlling Minitab by vba (visual basic) or vb Using Minitab Software 6
R Controlling and monitoring of measuring devices - AS9100 General Measurement Device and Calibration Topics 3
D Establishing and controlling process capability - Meaning of Phrases Capability, Accuracy and Stability - Processes, Machines, etc. 2
E Controlling CNC Machine Programs - Your recommendations appreciated Manufacturing and Related Processes 12
T Controlling filled out "forms" (eg Operator job specific work instructions) Document Control Systems, Procedures, Forms and Templates 3
B Controlling Reference Material Document Control Systems, Procedures, Forms and Templates 1
J Controlling Temperature and Humidity in the CMM Room and does anyone use Artifacts? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
R Procedure for Controlling Transmitted Technical Data - ITAR compliance Document Control Systems, Procedures, Forms and Templates 18
S Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 8
Raffy Controlling Handler, Tester, Computer and other Equipment Manuals. Document Control Systems, Procedures, Forms and Templates 2
H Controlling Continuously Changing Forms IATF 16949 - Automotive Quality Systems Standard 12
W Controlling Revisions of External Documents - Documents of External Origin Document Control Systems, Procedures, Forms and Templates 10
A Controlling Humidity in a Textile Testing Laboratory General Measurement Device and Calibration Topics 10
M Polyurethane Foam Testing and Controlling the Foaming Process Manufacturing and Related Processes 6
Gert Sorensen Controlling a male 6% Luer with permanent collar according to EN1707? General Measurement Device and Calibration Topics 5
C Controlling External Customer Documents (Documents of External Origin) Document Control Systems, Procedures, Forms and Templates 5
L "Document Controlling" Queries run to obtain information reported to customer Document Control Systems, Procedures, Forms and Templates 7
A Still Confused About "Controlling Suppliers Records" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3

Similar threads

Top Bottom