Requirements Traceability Database - Have one? Help create one?

W

wwcanoer

#1
I am setting up a new QMS system for a start-up and would like to track what documents are used to comply with various standards requirements & guidances (ISO13485, GHTF, QSR, etc.). (RTM, Requirements Trace Matrix)

My ideal system:
Import the requirements text of each standard and guidance. For each requirement, list the documents that address that requirement. Then be able to easily answer the following questions:
1) What documents address requirement yyyy?
2) What are all of the requirements that the xxx document must address? (providing a list of the text of every requirement. ISO, GHTF, QSR, etc…)

Choices:
- Excel is cumbersome for these many to many relationships that are better suited to a database.
- All of the requirements software that I looked at have a zillion entries for each requirement and each use case or test but I don’t need 90% of it. (I only looked at a handful of the zillion programs that are out there but did not see any promising leads for a light free one.)
- I could create an MS access database (but it has been 8 years since my last db, so it is not as simple as I thought)
- I quickly checked for free online databases (very few out there) but the ones I looked at don’t allow import from a file (i.e. the standards text). There are free dbs for placing dbs in websites but looked like more of a learning curve than using the MS access that I know (though it has been a while).

Question:
Does anyone have a database (or other system) that they could share or recommend? Anyone want to help create an MS Access database for this?

Discussion:
I have found various gap analysis and checklists as MS Word tables or spreadsheets but then I cannot easily link the text note/response to the actual document or doc status.
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
Question:
Does anyone have a database (or other system) that they could share or recommend? Anyone want to help create an MS Access database for this?
I would jump in and say "Sure, I will" but there would be a fee involved and I'm in the US...and I would be using Filemaker Pro instead of Access.

The hardest part of building a customized Dbase (as you probably already know) is deciding what you want the Dbase to do for your specific needs...that's why most Dbases for this do just about everything...that makes them more acceptable to the general market.

If I may suggest, decide pretty thoroughly want you want it to do, and how you will mine the data later, then check out Access programmers in Switzerland and farm the job out. If you already have decided the main functions, the cost should not be all that high. Us Dbase builders spend most of our time helping the customer/company decide what they want...the build doesn't take all that long if the target is already well established (and doesn't get revamped halfway through the build process).

JMO...
 
Thread starter Similar threads Forum Replies Date
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
R Traceability on Unmarked Parts - AS9100 requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
N FDA Traceability Requirements - Component lots ISO 13485:2016 - Medical Device Quality Management Systems 2
N Requirements for the identification and traceability of demo product for sales force US Food and Drug Administration (FDA) 1
A AS5553B Counterfeit Prevention - Traceability requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
T In house Calibration? Measurement equipment traceability requirements - ISO9001 General Measurement Device and Calibration Topics 12
Raffy ISO 13485 NIST Traceability requirements for calibration of test equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
A Active Implantable Medical Devices - Legal Traceability Requirements ISO 13485:2016 - Medical Device Quality Management Systems 7
R Drilling Service Identification and Traceability Requirements Quality Manager and Management Related Issues 4
P Medical Device Raw Material Traceability Requirements Other Medical Device and Orthopedic Related Topics 6
M Medical Device Outsourcing Batch Traceability Requirements Other Medical Device and Orthopedic Related Topics 2
D Are we doing enough to meet Identification and Traceability 7.5.3 Requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
F Traceability Requirements for Computer Hardware Equipment under ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
E Traceability Requirements for Medical Device History Records (DHR's) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P What is to be documented to fulfill the requirements of ?820.65 Traceability? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Traceability Studies and Requirements for MSA (Measurement Systems Analysis) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
G Medical Device Accessories (e.g.: ECG Patient Cables) - Traceability Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
A Design Traceability Matrix Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Y AS9100C 7.5.3 Identification and Traceability - Interpretation and Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
S ISO 17025 requirements not enough to prove NIST Traceability? ISO 17025 related Discussions 10
J Glue Record and Traceability according FDA Requirements US Food and Drug Administration (FDA) 1
thisby_ Components Traceability Requirements of a Class I Medical Device US Food and Drug Administration (FDA) 5
F Traceability Requirements for Implantable Medical Devices Other Medical Device Regulations World-Wide 2
P Component Traceability Requirements in a Class 2 Electronic Medical Device Other US Medical Device Regulations 5
I Traceability Requirements TL 9000 Telecommunications Standard and QuEST 5
C Ford Lot Traceability Requirements Customer and Company Specific Requirements 9
J Identification and Traceability requirements - Clause 7.5.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
H What are the requirements of traceability in FDA's Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Traceability of Requirements in the V-Model Qualification and Validation (including 21 CFR Part 11) 3
J Distributor Requirements - Vigilance and Traceability ISO 13485:2016 - Medical Device Quality Management Systems 7
T Class "F" Weight "Certificate of Traceability" Requirements - Calibration General Measurement Device and Calibration Topics 7
S Device History Records (DHR) Component Traceability / Serial Number Requirements ISO 13485:2016 - Medical Device Quality Management Systems 16
B Lot Tracking - Automotive Requirements - Identification and Traceability Records and Data - Quality, Legal and Other Evidence 18
D Traceability Matrix format for tracing user needs - Requirements, specifications, etc Food Safety - ISO 22000, HACCP (21 CFR 120) 11
J Identification and Traceability in Medical Device Tracking - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
Y ISO9000-3 - Software Traceability Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Ford and Prototype and Child Parts Traceability - Requirements of Ford Q1 Customer and Company Specific Requirements 4
M Traceability of Raw Materials - Requirements QS-9000 - American Automotive Manufacturers Standard 11
R PPAP Requirements for Tool Repair or Refurbishment APQP and PPAP 5
I France clinical trial requirements EU Medical Device Regulations 1
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
D Digital Healthcare - QMS requirements Other US Medical Device Regulations 3
M GP-12 procedure form and requirements Customer and Company Specific Requirements 1
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
D Customer Specific Requirements / Customer Requirements for Indirect Customers IATF 16949 - Automotive Quality Systems Standard 10
J Print Requirements Manufacturing and Related Processes 9
S Requirements for Certificate of Destruction for Surgical Instruments Medical Device and FDA Regulations and Standards News 2
R FAI & P.O. Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11

Similar threads

Top Bottom