What QMS and Regulatory Compliance Software are you using?

[Marc]

I appreciate your help with this.

Essentially I would like some current feedback or comments on the success people are having with hosted and/or on premise solutions for QMS and Regulatory Compliance. Which software systems are working best, etc.

Thanks again for your assistance.

Marc

 

[Ajit Basrur]

For QMS, we have a homegrown system that manages all qms documentation and applications like CAPA, Customer complaints and non conforming materials.

Regarding "Regulatory compliance", we have to mainly track the submission dates and anniversary dates which is done either thru Excel spreadsheets or SharePoint.

 

[Lucasmf]

Arena BOMControl. Full cloud based system. We use it for all our quality management system documentation, DMR, and regulatory compliance.

Design Dossier essentially becomes a BOM of the live documents from the DMR and DHF also maintained in the same system.

We've had to develop a lot of our own workflow processes because the product out of the box only provides for revision controlled items, changes to those items, supplier management.

Works pretty well once you set it up to suit your organization.

 

[Claes Gefvenberg]

• QMS: a Sharepoint application developed within the company. Works better and better after some teething problems.
• Internal audits: a homegrown Access application. It works very well, is tailor made for our needs and is updated as we go along.

/Claes

 

[Dakota Jackrabbit]

This may not be best place for this question, but rather than start a new thread ... . Has anyone experience with CAMA Software QCBD package. Our organization is looking at it and I would like to get some real world input.

Thank you in advance.

 

[mmagargee]

Hi Dakota,
I began the same type of investigation in April and CAMA was one that I looked at. I took someone's advice in one of the threads here and used Captera (a free software recommending service) to solicit suggested QMS matches to our needs.

I came away from the comparison by classifying these kinds of software into two groups: those built on top of an Access database, and those built on top of an SQL server database. The former is good for smaller operations having few users, while the latter is a better fit for site-wide operations where many users will be creating records and editing documents.

We are still in the midst of our search.

Mike

 

[mmagargee]

I forgot to say that CAMA seemed to be the Access database type of product.

 

[Dakota Jackrabbit]

Sat through webinar presentation of the Cama QCBD package. They have two versions; one built off Access, the other built off SQL. the package integrates various QMS functions NCM, calibration, CAR/PAR, deviations, customer complaints, supplier management, training records. it includes automatic notifications and e-signature approvals. It is advertised as ISO compliant, but would require knowledgeable implementation to assure compliance.

Overall could be useful. An organization can do the same functions though in SharePoint with similar integration and automations and have applications more suited to the organization's specific needs.