We are a clinical research company and are planning to introduce a vendor qualification tool to enable us to qualify vendors strategically, in a standardized, regular, automated, and digital manner, as well as to digitally support our own qualification by a customer using a knowledge database.
We are regularly qualified by our customers. This is done via questionnaires. Our Quality Assurance (QA) department receives these questionnaires, analyzes them, and divides the questions into different functional units according to topic. These units then spend a considerable amount of time researching the answers. Topics include data protection, procedures, and technical and organizational measures (TOM). A central knowledge database can speed up this process, as the topics covered in the customer questionnaires often overlap.
This knowledge database also supports the preparation and execution of audits, another way in which we are qualified by customers. These often involve short-notice surveys that do not allow for lengthy research.
Furthermore, we also qualify vendors with whom we work on projects. These vendors must meet our requirements as well as those of our customers. A vendor qualification tool that compiles questionnaires according to the customer involved and the field of activity, makes them available to the vendor via a platform, and requalifies them every two years will significantly reduce the workload. The same applies to the support provided by the knowledge database for creating questionnaires.
We have the following functional requirements for the tool we are looking for:
Knowledge database:
- Documentation of questions and the corresponding answers
- Documentation of topics and related explanations
- Categorization and grouping of questions and topics (e.g., by tags)
- Comprehensive and reliable search function
- User-friendly: The database must be fully accessible to users without in-depth IT knowledge. The user interface must be clear, logical, and intuitive.
- Question catalogs and articles can be exported and imported (e.g., as Excel files).
- Individual questions or question collections must be able to be assigned internally for processing and assigned a deadline
Questionnaires:
- Questionnaires can be created from answered questions in the knowledge database and from questions added ad hoc
- Question collection
- Questionnaires can be exported and imported (e.g., as Excel files)
- There is a selection function for quick and easy creation of questionnaires from a question collection
- Questionnaire templates: There are standardized questionnaires for different vendor types and customers involved in the project
- Upload functionality: Some questions require the option of uploading attachments (e.g., supporting documents) in order for the vendor to answer correctly
- Queries: It must be possible to ask questions about individual questions or their answers (both from the company side and from the vendor side).
- Deadlines for answering the questionnaires must be able to be set.
Vendor database with details on each vendor:
- Vendor status: Active, inactive, required, currently not in any project, validity of non-disclosure agreement
- Vendor data: Address and other information from the existing data collection system
- Vendor type
- Overview of the qualified areas (what can the vendor do)
- Overview of the projects in which the vendor is involved
- Contact list of the vendor's contact persons
- Geographical coverage (in which countries is the vendor active, what activities does it perform in this country or has it performed)
- Search and filter functions based on these criteria
- Overview of currently valid contracts: In which projects are the vendors active?
- Classification of vendors by activity (e.g., laboratory, app developer, etc.)
Vendor assessment:
- Internal project managers regularly evaluate the performance of vendors using a questionnaire
- This performance must be clearly presented in the vendor database (see result evaluation below)
Result evaluation:
- Evaluation system. What percentage of requirements does the vendor meet? Traffic light system to indicate vendor suitability
- In addition, the performance evaluation of the vendors by the PMs (vendor assessment) should be clearly presented. E.g., using a star system
- The QA department must be able to evaluate the individual QA responses (e.g., “accept” and “reject” with justification)
- Automatic generation of defect reports after evaluation of the vendor responses by us
- Overview of a vendor's answered questions and identification of answers that do not meet the ideal
- High-level overview of the results of vendor qualification and vendor assessment
Signature:
- Answered questions in the wiki and in the questionnaires must be able to be signed by internal employees and external recipients
Access authorization and roles:
- Access to the system must be controlled by the various roles.
- Questionnaires answered
- Create and manage questionnaires
- Knowledge base Answer questions
- Knowledge base Create articles and question catalogs
- Knowledge base administrator
- Questionnaire administrator
Automation and notifications:
- Vendors must be requalified every 2 years with the support of automation
- Announcements (e.g., new query), reminders, and deadlines must be sent automatically by the system via email
- Reminder function for upcoming requalifications, tracking of follow-up tasks with the vendor
- Escalation of missed deadlines
- Notification upon successful qualification
Data security:
- On-premises installation preferred
- Proof of validation
- Proof of identity of questionnaire recipients (e.g., token login)
Technical requirements:
- Ability to exchange data with other systems (via REST API): This means reading personal data and access authorizations from the leading system (CTMS) and providing metadata and access to the database.
Reporting:
- Status overview: A quick overview of the qualification status of vendors
- Flexible report: QA must be able to generate a targeted tabular report on the qualification status of individual vendors
- Overview of a vendor's qualification for auditors
Regulatory requirements:
- The following guidelines must be observed when implementing the VQT:
- EMA/CHMP/ICH/135/1995 Committee for Human Medicinal Products Guideline for good clinical practice E6(R2) Step 5
- ICH E6 (R2) Good clinical practice - Scientific guideline
- Company-specific SOP Vendor management and qualification
Approximately 70 software workstations are required.