Quality Compliance Software to meet ISO 13485 QMS and 21 CFR 820 Requirements

T

texkb

#1
The company I work for wants to look at implementing a software program for our quality system, currently our ISO 13485 QMS is all paper based. We are currently looking at Master Control and ETQ (Excellence Through Quality). I was wondering if anyone had any experience with either of those systems and could provide some feedback or knew of any other good software systems for quality control. Any advice would be greatly appreciated. The standards we have to meet are ISO 13485, 21 CFR 820, and 21 CFR Part 11. :thanx:
 
Elsmar Forum Sponsor

v9991

Trusted Information Resource
#2
Just in case if I missed the point...
What is the end-objective you are looking for...
...do Enterprise QMS software support QC-processes?

At least from pharma (Part 210 and 211) point of view, quality control processes involve: material receipt-analysis-release, specification, calibrations, etc., which are well supported by LIMS;

Routine QMS processes would involve: Document Management, Investigation, CAPA, Audits, Training, Incident, Complaints, etc.,
 
Last edited by a moderator:
G

Gert Sorensen

#3
There are many companies that claim that they have software that can fullfil the tasks that you mention. I have been in contact with both Master Control and EtQ when my previous company where looking at solutions, and both can deliver good software and help with implementation of the sw.

But, before you choose you really need to consider:

  • The exact things/processes you want to use it for?
    Some processes are hard to implement if others have not been implemented before (e.g. ECO's are dependant on Document Management). When implementing: Have patience, build the foundation before laying the roof! It pays of sooner than you think.

  • How knowledgeable their implementation partner is?
    Believe you me, some implementation partners talk the talk, but they sure don't walk the walk. They have no idea about the requirement in the medical device industry. We actually had one potential implementation partner who had to fly in an employee from France to demonstrate their SW. The implementation partner did not have the needed knowledge to do that. :mg:

  • How much backing there is in your organization for making this transition?
    Don't try to muzzle or slip something like this in. It will prolong the process. Involve people already now. They should be part of creating the URS (and that makes your validation easier :D).

  • Have you got a management sponsor at absolute toplevel?
    Implementation of this kind of SW takes time, costs money, and requires organizational changes. Is it within your mandate? Top level commitment is essential! TL needs to commit in public, and in writing.

  • What is your budget?
    Projects like these also have internal costs! Make sure that those costs are calculated up front as well, otherwise management is gonna be annoyed.

  • Does the potential supplier have a good reputation, and good references in other companies similar to yours?
    Make sure that they provide you with a list of references that you can call at your own will - or visit. Get the actual dirt on the companies. No company has a perfect track record; Use others experience to get a realistic assessment, choosing compliance SW is a long term commitment, make sure that you can accept your partner, incl. flaws.

  • How easy is it to hire employees in your area that are acquainted with either sw?
    Depending on geography this may be important. If you need to recruit a new administrator for the compliance SW then it is nice to have an idea up front if this is easy or not.

The above list is just to highlight some of the typical things that almost immediately derail an SW implentation.
 
P

paulbrowning

#4
Hi
I have had experience with MasterControl. I was the UK Champion for implementing it across (an unnamed, but VERY large) scientific company. I worked closely with MasterControl staff which where very helpful in our project planning.
The systems itself is ok, great modular parts. I used doc control and training modules. It is overcomplicated in parts, but the tied down parts have their plus points too.

The basis of the system is around InfoCards (a database route really). This links to all other parts of the database (eg versions, approval groups etc). It is very easy system to administer, but can cause a bit of confusion for users unfamiliar with IT. :)

It is also VERY expensive. So you'll need to get them in to quote you based on the user levels, then assess if its worth it vs your own bespoke solutions or SharePoint.
 
Thread starter Similar threads Forum Replies Date
B ETQ Quality & Compliance Software - Opinions or Reviews wanted Quality Assurance and Compliance Software Tools and Solutions 35
B Web Based Quality Management Compliance Software Quality Assurance and Compliance Software Tools and Solutions 5
R Role of quality compliance in SAP Software Quality Assurance 2
qualprod Is a Corrective Action Expected if a Quality Objective is not in compliance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
A Global Medical Device Quality Compliance Overview Presentation - Help Wanted Other Medical Device Regulations World-Wide 2
D Support Group for Global Quality, Regulatory, and Trade Compliance Professionals Other Medical Device Regulations World-Wide 0
P Making Quality and Compliance Invisible Imported Legacy Blogs 0
V Do you differentiate Quality and Compliance? Quality Manager and Management Related Issues 11
B ISO 9001 Compliance or Excellence: How is Quality best achieved ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Quality Assurance procedures for EMC (Electromagnetic Compatibility) Compliance CE Marking (Conformité Européene) / CB Scheme 4
C Shortcomings of Compliance Focus Quality Management System (QMS) Quality Manager and Management Related Issues 3
A Advice for a barely promoted Quality and Compliance Manager Quality Manager and Management Related Issues 1
A Are environmental compliance documentation quality records? Document Control Systems, Procedures, Forms and Templates 5
J Help with AQAP related Quality Plan in compliance with NATO AQAP 2110 and AQAP 2210 Various Other Specifications, Standards, and related Requirements 14
J Can "Compliance to ALL Requirements" be an Acceptable Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 211 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
T Common Practice to have both a Compliance Manager and a Quality Manager? Misc. Quality Assurance and Business Systems Related Topics 13
E Please Review our Quality Policy Statement for content and compliance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K Quality Control/Assurance in the Metal Industry Quality Tools, Improvement and Analysis 10
C Quality Manager as part of Management - 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
Marc Quality Assurance Specialists Job Openings, Consulting and Employment Opportunities 0
B Quality Manager Retiring IATF 16949 - Automotive Quality Systems Standard 5
S Outsourced storage Quality Agreement ISO 13485:2016 - Medical Device Quality Management Systems 7
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
N Guidance - Cost of Good Quality Misc. Quality Assurance and Business Systems Related Topics 2
D Quality plan for moving locations ISO 13485:2016 - Medical Device Quality Management Systems 3
was named killer Job Opportunity-Quality Engineer-Tampa Florida Job Openings, Consulting and Employment Opportunities 0
Marc Job Opportunity – Quality Assurance Specialist - Suspense 7 April 2021 Job Openings, Consulting and Employment Opportunities 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
normhowe "The Problem with Quality Management: Process orientation, controllability and zero-defect processes as modern myths" Book, Video, Blog and Web Site Reviews and Recommendations 2
J Quality Objective for QMS prior to Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Quality Objectives and resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 6
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T Quality auditor legal right to see Board meeting minutes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 3
C Budgetary cost to obtain ASME NQA-1 Quality Program Certification Quality Management System (QMS) Manuals 0
O Soft and technical skills for a VP of Quality Career and Occupation Discussions 1
P MedWatch Report from a hospital due to a quality issue US Food and Drug Administration (FDA) 5
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Application to Chartered Quality Institute - MCQI ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
K Quality Agreement MDR - The manufacturer is outside of EU Other Medical Device Related Standards 4
Sidney Vianna Informational APQP4Wind - Advanced Product Quality Planning for the Wind Power Supply Chain APQP and PPAP 3
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Supplier protocol for the Quality Supplier Quality Assurance and other Supplier Issues 6
bruceian Software Quality Metrics Software Quality Assurance 11
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
Bev D Essential References for Practical Quality Engineering Misc. Quality Assurance and Business Systems Related Topics 0
optomist1 Automotive News The Cost of Inspecting In Quality IATF 16949 - Automotive Quality Systems Standard 7

Similar threads

Top Bottom