Choosing the correct software for your organisation is a tricky task and even more so when you are working in a regulated environment.
It’s one thing finding a great software package but if the vendor does not take their quality system seriously this could have a dramatic effect on the evolution and robustness of the solution.
They need to take their quality efforts as seriously as you take yours otherwise product quality and patient safety could be compromised.
An overall quality audit should be performed on each vendor before a decision is made, below are a list of questions that you could ask each vendor specifically on their quality system.
If the software vendor does not take their Quality System seriously you need to walk away.
Quality System Questionnaire
- Does the company have an established and Documented Quality System?
- Does the Quality System adequately reflect the client’s quality engineering policies?
- Is the responsibility for Quality defined (SOP)? What are their qualifications?
- Is Quality System documentation adequately controlled in terms of review, approvals and distribution
- Is the QS documentation regularly updated and otherwise maintained appropriately? (frequency)
- Are there procedures for reviewing the performance of the QS e.g. Internal Audit, Management Review?
- Are there training procedures and Job specifications? Are these adequate for the Maintenance of the QS
- Is there a Quality Plan for the Design, Development and Implementation of the products?
- Do the company use Sub Contractor’s?
- Do the company have control over any Sub Contractor’s QS? e.g. Vendor Assessment, Specification, Documentation review and approval?
- Do the company have access to relevant Sub-contractor Quality documentation?
- Is Sub Contractor’s Quality System compatible with the previous questions of this section?
- Have the Sub Contractors been audited? Review the report?
- Has accreditation/registration been achieved for: BS 5750 Pt. 1 or 2, TickIT, ISO 9000, Other (name
- Does the company operate to GAMP for computer systems?
- Are there SOPs for QC? Is there a release procedure?
- Is there an out-of-specification procedure?
Choosing the correct software application for your organization is a very tricky task and one that takes alot of upfront planning in order to make the correct choice.
The task has even got more difficult with the emergence of cloud based technology and how that impacts the overall validation process.
Remember to outline your requirements clearly and get buy-in from the other business owners.
