Pharmacovigilance digitisation solution – maintenance & support – national government tender

Returnable documents:

20 points = comprehensive plan outlining all key milestones 10 points = proposal not comprehensive, have respond to 50% of key milestones. 0 point = NO project plan, respond less than 50% of key milestones. Total 100 minimum threshold: to be eligible to proceed to the next stage of the evaluation (demo/ presentation) the bidder must achieve a minimum threshold score of 70 points. Technical proof of concept (demonstration) requirements technical proof of concept (poc) will be conducted in two phases, as outlined below: phase 1: system demonstration • objective: the purpose of phase 1 is to allow the bidder to present a technical demonstration of the proposed solution to the evaluation committee. • Scope: the demonstration should focus on showcasing the core functionality of the system in alignment with the specified requirements outlined in the tender documentation. • Key expectations: - the bidder must demonstrate how the system meets the technical specifications and functional requirements. - The presentation should highlight key features and capabilities that align with the needs of the end users. - The bidder must provide a clear user guide or walkthrough, enabling committee members to understand how to navigate and operate the system effectively. - Demonstrations must be live (not prerecorded), and the system should reflect a realistic, working environment. Phase 2: system piloting • objective: the purpose of phase 2 is to allow the evaluation committee to test and evaluate the proposed system in real-world scenario, ensuring that IT performs as expected under actual operating conditions. SAHPRA/2026/PHARMACOVIGILANCE digitization bid NO: SOLUTION/RFB006 sahpra bid document section a 3: evaluation process/ criteria • scope: the pilot will simulate typical use cases and workflows based on organizational needs, giving evaluators an opportunity to interact directly with the system. • Key expectations: - the pilot system must allow evaluation committee members to: ✓ perform core functions independently. ✓ Assess system performance, usability, and reliability. ✓ Technical support must be available from the bidder during the pilot phase to address queries and issues in a timely manner. System demonstration and presentation functions: 40 reporter facing - data collection functionalities: 1. Online portal - public-facing, user-friendly web interface for reporters, responsive design compatible with mobile and desktop devices and multi-language support (if applicable). 2. User registration - secure self-registration process with identity verification as needed, capture of relevant user profile information (e.g., Role, organization, contact details) and optional approval workflow for account activation. 3. User authentication and access management - role-based authentication (e.g., Reporter, reviewer, administrator), support for modern authentication protocols (oauth2, saml, mfa) and password management and account recovery features. 4. Ability to submit online application - dynamic, user-guided forms with validation and conditional logic, file upload support for attachments (e.g., Documents, images), auto-save, draft, and resume later functionality and unique submission ID and confirmation receipt. 5. Communication & notifications - automated email/sms notifications for key actions (e.g., Submission confirmation, status updates), in-portal messaging or announcement area and configurable templates and communication rules. 6. Coding functionalities - integration of coding tools for standardized data entry (e.g., Product codes, incident types), autosuggestion or search-enabled dictionaries for consistent classification and support for international and local coding standards (e.g., Meddra, icd, snomed, etc.). SAHPRA/2026/PHARMACOVIGILANCE digitization bid NO: SOLUTION/RFB006 sahpra bid document section a 3: evaluation process/ criteria 7. Industry facing and data extraction 40 points= all seven functions met 20 points= five functions met 0 point= 0- four functions official facing major functionalities: 60 1. Application eligibility checks - automated validation of applicant criteria based on predefined rules and policies, real-time eligibility determination with integration to external databases and registries and audit trails for all decisions. 2. Allocation process, case management and end to end tracking - intelligent allocation of cases/resources based on predefined logic (e.g., Priority, region, expertise), full lifecycle case management with status updates, task assignments, and SLA monitoring and end-to- end tracking and traceability of every application or case. 3. Product and incident dictionary management - centralized repository for maintaining standardized definitions, classifications, and codes for products and incidents, version control and approval workflows for updates and support for regulatory taxonomies and coding systems. 4. Document management - secure document upload, storage, versioning, and retrieval with metadata tagging and classification for searchability and role-based access control and audit logging for compliance. 5. Signal detection - real-time monitoring and detection of anomalies, trends, or early warning signals using statistical or AI models, alerts and notifications for predefined thresholds or patterns. 6. Integration capabilities with flexibility - api-driven architecture for interoperability with internal and external systems, support for various integration methods: rest, soap, file-based, event-driven, and is scalable and configurable integration framework to adapt to evolving needs. 7. Artificial intelligence (AI) - ai-powered decision support (e.g., Application assessment, risk scoring). SAHPRA/2026/PHARMACOVIGILANCE digitization bid NO: SOLUTION/RFB006 sahpra bid document section a 3: evaluation process/ criteria 8. Dashboard and reporting - interactive dashboards for real-time data visualization and monitoring, ai-enhanced analytics for trend identification, forecasting, and KPI tracking and customizable reports for operational, strategic, and regulatory needs. Data extraction 60 points= all eight functions met 40 points= six functions met 0 point= 0 – five functions total 100 a. The score for functionality shall be calculated as follows: i. The score of each panel member shall be added together and divided by the number of panel members to establish the average score obtained by each individual bidder for functionality. Ii. The overall minimum technical threshold is 60 points (functional and presentation). Bidders that do not meet the minimum technical threshold will not be evaluated further for price and specific goals. B. Price and specific goals points i. All remaining bids will be evaluated as follows: ii. The 80/20 preference point system will be applied. Points for price and specific goals will be awarded in accordance with the stipulations in the preference point claim form in terms of the preferential procurement regulations, 2022. Iii. If appropriate, implied contract price adjustments will be made to the cost proposals of all remaining bids. Iv. The point scored for the specific goals for each acceptable bid will now be added to the price point. V. The bid must be awarded to the supplier that obtained the highest preference points or may be awarded to a supplier that did not score the highest points only in accordance with section 2(1)(f) of the PPPFA. c. Adjudication of bid i. The relevant award structure will consider the recommendations and make the final award. The successful bidder will usually be the service provider scoring the highest number of points. Ii. The bid must be awarded to the supplier that obtained the highest preference points or may be awarded to a supplier that did not score the highest points only in accordance with section 2(1)(f) of the PPPFA. SAHPRA/2026/PHARMACOVIGILANCE digitization bid NO: SOLUTION/RFB006 sahpra bid document section a 4: contract form contract form: rendering of services this form must be filled in duplicate by both the service provider (part 1) and the purchaser (part 2). Both forms must be signed in the original so that the service provider and the purchaser would be in possession of originally signed contracts for their respective records. Part 1 (to be filled in by the service provider) 1. I/we hereby undertake to render services described in the attached bidding documents to sahpra in accordance with the requirements and task directives/proposals specifications stipulated in bid number SAHPRA/2026/PHARMACOVIGILANCE digitization SOLUTION/RFB006 at the price/s quoted. My/our offer/s remain binding upon me/us and open for acceptance by the purchaser during the validity period indicated and calculated from the closing date of the bid. 2. The following documents shall be deemed to form and be read and construed as part of this agreement: 2.1 Bidding documents, viz  invitation to bid  proof of tax compliance status  pricing schedule(s)  filled in terms of reference/task directive/proposal  preference claim form for preferential procurement in terms of the preferential procurement regulations  bidder’s disclosure form  special conditions of contract 2.2 General conditions of contract 2.3 Other (specify) 3. I/we confirm that i/we have satisfied myself as to the correctness and validity of my/our bid; that the price(s) and rate(s) quoted cover all the services specified in the bidding documents; that the price(s) and rate(s) cover all my obligations and i accept that any mistakes regarding price(s) and rate(s) and calculations will be at my own risk. 4. I/we accept full responsibility for the proper execution and fulfilment of all obligations and conditions devolving on me/us under this agreement as the principal liable for the due fulfilment of this contract. 5. I/we declare that i/we have NO participation in any collusive practices with any bidder or any other person regarding this or any other bid. 6. I confirm that i AM duly authorised to sign this contract. Name (print) witnesses capacity 1 signature 2 name of firm date: date SAHPRA/2026/PHARMACOVIGILANCE digitization bid NO: SOLUTION/RFB006 sahpra bid document section a 4: contract form contract form: rendering of services part 2 (to be filled in by the purchaser) 1. I ................................................................................ In my capacity as ..................................................... Accept your bid under reference number .................................................... Dated ........................................... For the rendering of services indicated hereunder and/or further specified in the annexures. 1. An official order indicating service delivery instructions is forthcoming. 2. I undertake to make payment for the services rendered in accordance with the terms and conditions of the contract within 30 (thirty) days after receipt of an invoice. Points price (all total claimed for applicable completion preference description of service each taxes date points specific included) claimed goal e3. I confirm that i amexamplduly authorised to sign this contract. Signed at on name (print)

1. The proposals should outline the approach, provisional timetable and proposed resource schedule that informs the costing based on the above functional and non-functional requirements. 2. The proposal should allow for data standardisation/normalisation support up to 60 hours per category of health products 3. The proposal should detail the project milestones and related payment points and should reflect a modular approach. The implementation will follow a modular approach, ensuring flexibility, scalability, and phased delivery of functionality across all regulatory domains within sahpra’s mandate: a) base platform and functional requirements the initial phase will focus on developing and deploying the base digital platform, incorporating core functional requirements (modules 1 through 6) applicable across the various categories of health products regulated by sahpra, including: 1. Orthodox and biological medicines 2. Medical devices and in vitro diagnostics (ivds) 3. Veterinary medicines 4. Complementary medicines this approach enables standardized functionality while allowing customization and optimization for each product category. Nb: the implementation of the veterinary medicine functional requirements can be done on a phase- in approach (not on the initial implementation phase) and should be included in the costing. B) non-functional requirements all non-functional requirements including system performance, security, scalability, interoperability, usability, and compliance with relevant ICT and data protection standards will be incorporated across all modules to ensure a robust and sustainable platform. C) system maintenance and support following implementation, the solution will be supported through a 36-month maintenance and support period, providing tier 3 (vendor-level) support to ensure system stability, performance optimization, updates, and continuous improvement. # Note the cost breakdown in this granular way is required to assist in defining the value of each sprint to ascertain funding flows required for the total project or part of project covering for example only 1 health product category or 2 health products etc. Proposed resources to consider: pharmacovigilance subject matter expert • a pharmacoepidemiologist/medical doctor/other expert with in-depth knowledge and expertise in pharmacovigilance, the science of monitoring the safety of medications (for all health products or specific product disciplines) and experience with pharmacovigilance software tools. Responsibilities: SAHPRA/2026/PHARMACOVIGILANCE digitization bid NO: SOLUTION/RFB006 sahpra bid document section a 3: evaluation process/ criteria o provide input into the user requirement for a software tool to assist with the case management, signal detection and communication with rapporteurs and holders of certificate of registration o provide workflow processing input from a regulator’s perspective in terms of best practice work procedures with review and analyse safety data related to the project throughout the development process. O assist with development of system guidelines for the different modules – to standardise work practices and be retained as system guidelines. O conduct training with sahpra staff business analyst • analyses business requirements, completes detailed market research on best practice standards with regards to work practices within pharmacovigilance units within other regulators to have a broad and comprehensive understanding of the ways of working and what business practices could be adopted refined within sahpra to transitions to more efficient work processing (engagements with other regulatory authorities that sahpra have agreements with could be considered and any other contacts could be used) to also translates business requirements then into a optimal business process and transcribe them into technical specifications for the development team. Responsibilities: o elicit and document business needs and requirements. O define the scope and functionality of the project. O create user stories and acceptance criteria. O liaise between stakeholders and the development team. Ux/ui designer • designs the user interface (ui) and user experience (ux) for the project, focusing on usability and user satisfaction. Responsibilities: o conduct user research to understand user needs and behaviours. O develop wireframes, prototypes, and mock-ups of the user interface. O ensure the design is intuitive, user-friendly, and aesthetically pleasing. O collaborate with developers to ensure a smooth transition from design to implementation. Front-end software engineer • develops the user interface (ui) of the project, focusing on the visual elements and interactivity. Responsibilities: o write front-end code using html, css, and javascript frameworks. O implement the ui design specifications created by the ux/ui designer. O ensure the ui is responsive and works across different devices and browsers. O integrate with the back-end developed by the back-end developers. Back-end software engineers • develops the server-side logic and functionalities of the project. Responsibilities: o design and implement the database structure. O write server-side code to handle data processing and business logic. O ensure the back-end is secure, scalable, and performant. SAHPRA/2026/PHARMACOVIGILANCE digitization bid NO: SOLUTION/RFB006 sahpra bid document section a 3: evaluation process/ criteria o integrate with any necessary external apis or services. O ai/ml developers for case triage, data cleansing, auto-coding and classifications data scientists • analyse data to extract insights and inform decision-making. O responsibilities: o develop and implement data analysis models and algorithms. O clean, prepare, and analyse data relevant to the project. O identify trends and patterns in the data. O communicate insights and recommendations to stakeholders. AI engineer • collaborate with stakeholders to understand the business problem • translate the problem into a solvable AI or ml task • define success metrics (e.g., Accuracy, precision, business kpis) • identify relevant datasets and sources • clean, normalize, and prepare data for modelling • handle data labelling (manual or automated) • work with structured and unstructured data • select appropriate algorithms (e.g., Regression, neural networks, transformers) • evaluate model performance using validation techniques • ensure models remain compliant with regulations and ethical standards project manager: • leads and oversees the project execution, ensuring IT is completed on time, within budget, and meets project goals. O responsibilities: o develop and manage the project plan and schedule. O manage project resources and budget. O track project progress and identify and mitigate risks. O facilitate communication and collaboration among stakeholders. All bidders must take note of the evaluation process that will be followed 3. Evaluation process 3.1. Compliance with minimum requirements 3.1.1 All bids duly lodged as specified in this request for bid will be examined to determine compliance with bid requirements and conditions. Failure to comply with or submit any of the following items may render a bid non-responsive and not be evaluated further. Compliant? Reference description yes NO part 1 signed special conditions of bid and contract part 2 tax compliance requirements part 3 completed and signed declaration of interest (sbd 4) part 5 completed and signed invitation to bid (sbd 1) SAHPRA/2026/PHARMACOVIGILANCE digitization bid NO: SOLUTION/RFB006 sahpra bid document section a 3: evaluation process/ criteria part 7 proof of registration on the csd or maaa number if there will be subcontracting, proof of csd registration of the sub-contractor must be submitted 3.1.2 Failure to comply with or submit pricing schedule (sbd 3.1) Will render a bid non-responsive and not be evaluated further. Compliant? Reference description yes NO part 6 completed pricing schedule in the prescribed format (sbd 3.1) 3.1.3 Bidders must submit their proposal by the closing date and time. Proposals submitted after the closing date and time will be disqualified from further evaluation. 3.1.4 Hard-copy proposals must be recorded in the tender submission register at sahpra reception. Hard-copy proposals not recorded on the tender submission register at sahpra reception will be disqualified from further evaluation. 3.2 Determination of score for functionality 3.2.1 The evaluation criteria and weights for mandatory, functionality and presentation as indicated in the table below will apply. Mandatory requirements provide yes= evaluate evidence/page NO. further and/or location no=don’t evaluate further part 1: a. The bidder must be an accredited reseller or partner or original developer, accredited by the original equipment manufacturer (oem) or original software manufacturer (osm) to supply, maintain, and support the pharmacovigilance (pv) software, or provide a signed letter affirming such authorization. B. The bidder must comply with all product/service functional requirements by completing and signing annex a. If the condition above is not met, bidder will be not evaluated further. Technical evaluation criteria provide maximum evidence/page points to be NO and/or awarded location part 2: bidders capability and experience 1. Reference letters. 30 SAHPRA/2026/PHARMACOVIGILANCE digitization bid NO: SOLUTION/RFB006 sahpra bid document section a 3: evaluation process/ criteria the bidder must have provision a vigilance information system(s) for three (3) customers in the last ten (10) years provide a letter(s) from institutions that conduct vigilance regulatory activities to whom the information system(s) was delivered to this effect. Each letter must be dated, signed and on a letterhead of the customer and indicate: a) the customer company name and physical address. B) customer contact person’s name, telephone number and email address. C) project <or service> scope of work relating to e.g., Individual case safety report (icsr) management/ processing, signal management etc but non-exhaustive. D) project start and end date. The bidder must provide reference details from customers to whom the pv solution/software was supplied, maintained and supported in the past ten (10) years from the closing date of this bid.

NO specific requirements found