Hello good people of the world! This post is about evaluating 3rd party software solutions for GMP use and is based on this excellent questionnaire from the Canada-based company Montrium: 17 Must-Ask Questions for Demonstrations of Regulated EDMS’
The following are some topics to focus on:
- How does the software system meet user requirements out-of-the-box? Ask about the user interface, workflows, notifications, branding options, and standard reports.
- How are customization requests handled? What is the cost? The typically turn-around time? Are customizations billed at Time and Materials (T&M) or at a fixed cost?
- How many users/documents/data points does the system support? I.e. how scalable is it?
- How is archiving and long-term retention handled in the system. If you needed to move data out and decommission the system, how easy would it be? (Be sure to think of the entire lifecycle of the software system)
- Does the system integrate with other 3rd party solutions? Which ones specifically? Is there a well-supported Application Programming Interface (API)?
- What kind of technical support is provided? Is there a standard Service Level Agreement (SLA)? Can the SLA be modified?
- What is the technology like (web-based, client/server, other)?
- What are the hosting options (onsite, cloud, hybrid)?
- What are the minimum software requirements for client OS, web browser, etc. Get specific versions.
- What are the pricing structures?
- How long does deployment typically take?
- Is the system capable of meeting 21CFR11 and/or Eudralex Vol. 4 Annex 11 requirements?
- Does the system support standard taxonomies like TMF Reference Model, EDM Reference Model, ICH eCTD Guidelines (for clinical trial data)?
- What documentation is included? Operating manual? Admin guide? URS, FS, SDS?
- What validation documentation/services are provided?
- What is the vendor’s quality system like. Perform a vendor audit.
- Does the system come with pre-loaded templates? Are templates customizable?
- Does the system have the capability of being accessed by 3rd parties for collaboration?
- Does the system allow for custom numbering formats?
- How does the system handle delegation of tasks?
- Does the system allow for customization of reports?
- Does the system allow for export of data/metrics/analytics?
What considerations do you feel are important in evaluating a 3rd party software solution? Please leave a comment below.
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