If you're thinking about getting a GxP system for your work in life sciences, it's important to ask the right questions.
To help you get the best out of your inquiries with potential vendors, here are 10 important questions you should ask, along with what type of answer to expect, what to confirm, and the documents you should typically get to substantiate the vendor claims.
Area of Interest | Vendor Question | Expected Answer Type | What to Confirm? | Typical Documents |
Compliance | Does the system meet all the necessary GxP regulations and guidelines, like FDA 21 CFR Part 11 or EU Annex 11? | Yes/No | That the system meets the regulatory requirements that are specific to the use you have in mind for the system. | Compliance certificates, regulatory audits, certification of software or system conformance. |
Validation | Can you provide documentation and services to support the validation of your system? | Yes/No | How much vendor knowledge can be leveraged to facilitate your computer system validation (CSV) activities. | CSV document templates (ex. validation plan requirements, risk assessment, test protocols and scripts, and test reports). Standardized CSV service offerings. |
Data Integrity | How does the system ensure data integrity, including audit trails, electronic signatures, and data security measures? | Detailed Explanation | How data integrity is ensured (e.g., audit trails, encryption, data structure and data flow). | Audit trail logs, data encryption certificates, security compliance reports. |
Scalability | How well can your system accommodate future growth and organizational changes? | Yes/No | Can the system’s performance handle your current and future business needs. | Scalability test reports, , system architecture documentation, or case studies showing scalability in action. |
Integration | What are your integration capabilities? | Detailed Explanation | Compatibility with your IT landscape and its expected evolution. | Integration protocols, API documentation, or proof of integration with similar systems. |
User Training | What training and support do you offer to ensure an effective use of the system by our team? | Detailed Explanation | The level and quality of the support you’ll receive in relation with user adoption and compliance training through system’s lifecycle. | Training schedules, user manuals, online tutorials, and training completion certificates. |
Maintenance and Support | What are your policies and processes related to system maintenance, updates, and technical support? | Detailed Explanation | That system releases will be well managed and that you will be able to keep relying on quality outputs from your vendor and that adequate policies, processes, updates, and support are in place. | Support agreements, SLA (Service Level Agreement) documents, maintenance schedule, and update logs. |
Cost | What are the total costs associated with the system, including initial purchase, implementation, training, ongoing maintenance and end of life? | Detailed Explanation | Your total costs for acquiring, operationalizing and maintaining and decommissioning the system. | Cost breakdown sheet, contract pricing details, and potential future expense estimates. |
Vendor Experience | What is the vendor's experience and track record in the life sciences industry, and can they provide references from other clients? | Detailed Explanation | The trustworthiness of the vendor within the life sciences and the quality of their products. | Client references, case studies, testimonials, and records of past implementations in similar industries. |
Customization | Can the system be customized to meet your specific needs and workflows? | Yes/No | The ability for the system to be adapted to your specific, or evolving, needs without jeopardizing its validated state or requiring custom development. | Customization proposals, workflow diagrams, and impact assessments on updates. |
Breakdown Per Area of Interest
Compliance
It’s important to ensure that the system meets all the necessary GxP regulations and guidelines, such as FDA 21 CFR Part 11 and EU Annex 11. The answer should be Yes/No. You should confirm that the system complies with the regulatory requirements specific to your intended use. Be sure to ask for supporting documents like compliance certificates, regulatory audits, or software certification.
Validation
GxP systems must be validated. Vendor should ideally offer documentation and services to support this activity. Your aim here should be to better understand how computer system validation (CSV) activities will be supported. You should understand, and be comfortable with, the validation strategy your vendor is proposing. Be sure to request CSV document templates, such as validation plans, risk assessments, and test protocols, if they are available, as well as standardized CSV service offerings.
Data Integrity
A detailed explanation on how the system ensures data integrity will reduce potential nasty surprises down the road. This includes getting basic conformations on topics/features such as audit trails, encryption, and how data is structured and flows within the system. Confirm that data integrity safeguards are in place and proportional to the information stored within the system. Request supporting documents like audit trail logs, data encryption certificates, and security compliance reports.
Scalability
The system must be able to accommodate future growth and organizational changes. Confirm how the system's performance can handle both your current and future business needs. Request supporting documents such as scalability test reports, system architecture documentation, or case studies demonstrating scalability in action.
Integration
The system must be able to integrate with your current IT infrastructure and other software applications. Confirm its compatibility with your existing and future IT landscape. Request integration protocols, API documentation, or proof of successful integration with similar systems.
User Training
Training and support are crucial to ensure your team effectively uses the system and maintains compliance. Ask for a detailed explanation of the level and quality of support provided for user adoption and training. What will the on-boarding process look like, from an end user perspective? Request documents such as training schedules, user manuals, online tutorials, and training completion certificates.
Maintenance and Support
The vendor should offer a detailed explanation of their policies and processes for system maintenance, updates, and technical support. Confirm that system evolutions are well-managed and that you can rely on consistent, high-quality service. Request support agreements, Service Level Agreement (SLA) documents, maintenance schedules, and update logs. Think about services and contractual clauses tied with end of life. Will you be able to easily get your data back if you ended up needing to switch system 5 years from now?
Cost
A detailed explanation of all costs is essential, including the initial purchase, implementation, training, ongoing maintenance, and end of life. Confirm the total costs for acquiring, operating, maintaining and decommissioning the system. Be sure to request a cost breakdown sheet, contract pricing details, and estimates for potential future expenses.
Vendor Experience
The vendor’s experience and track record in the life sciences industry are crucial for building trust and ensuring product quality. Expect a detailed explanation and ask for client references, case studies, and testimonials. These will provide a clearer picture of the vendor's expertise and the success of past implementations in similar industries. If available, you should favor independent reviews over biased white papers produced but the vendors.
Customization
Ask if the system can be customized to meet your specific needs and workflows. Confirm that customization needs will not compromise the system's validated state, impact future updates or require extensive custom development. Request documentation such as customization proposals, workflow diagrams, and impact assessments on future updates.
Conclusion
This table is provided as a practical tool to help you build a software vendor assessment strategy around. It is not an exhaustive list, and it should also be adapted to your specific requirements and concerns.
Selecting a new system, especially one with GxP impacts, is a critical decision with lasting consequences. Asking the right questions and gathering the necessary information to substantiate vendor claims are paramount to reduce the risks you are taking. By obtaining a clear view around those key elements, you'll be better prepared to make informed decisions and will avoid what could be very nasty surprises down the road.
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