Pharmacovigilance digitization solution for sahpra: cots software, maintenance, and support

SCM contact for clarifications: Precious Mnguni, Email: [email protected]. Submission address: Loftus Park, Building A, 402 Kirkness St, Arcadia, Pretoria, 0083 (2nd floor, office hours 08:30–16:00).

Submit 1 original + 2 copies + 1 USB in a sealed envelope. Envelope must be marked with: bid number (SAHPRA/2026/PHARMACOVIGILANCE DIGITIZATION SOLUTION/RFB006), closing date/time (31 MARCH 2026 @ 11:00), and bidder’s name/address. Deliver to: Loftus Park, Building A, 402 Kirkness St, Arcadia, Pretoria, 0083. Deposit into tender box or hand in at 2nd floor during office hours (08:30–16:00, Mon–Fri). No posted, faxed, or emailed bids accepted. Late bids (even 1 second after 11:00) will be returned unopened. Official time source: Telkom (dial 1026). Bid validity: 90 days from closing date. Documents submitted on time will not be returned. Accept General Conditions of Contract (download from Treasury: http://www.treasury.gov.za/divisions/ocpo/sc/GeneralConditions/General%20Conditions%20of%20Contract.pdf).

Evaluation follows a 80/20 preference point system: Price 80 points, Specific Goals (B-BBEE) 20 points. Total scoring: 100 points (Functionality 40, Presentation 40, Price/Specific Goals 20). Compliance with minimum requirements is mandatory. Bids must meet all stipulated conditions to proceed to evaluation. Evaluation stages: 1) Compliance check (mandatory requirements), 2) Functional/technical assessment (40 points), 3) Presentation/clarity (40 points), 4) Price and preference points (20 points).

Scope: Implement a Pharmacovigilance digitization solution (part of RIMeS ecosystem) with 36-month maintenance/support and option to renew for 24 months. Must include: COTS software customization, training (ToT), user manuals, and ongoing technical support. Functional requirements: 1) Data Collection: Multi-source (HCPs, patients, manufacturers, clinical trials, etc.) via mobile/web; support E2B R3, FDA3500A, IMDRF, VEDDRA, TGA formats; structured data entry with controlled vocabulary (IDMP, MedDRA, WHO-DD, VEDDRA). 2) Case Management: Triage, data quality review, assessment (seriousness, causality), workflow tracking, notifications, escalations. 3) AI Capabilities: Auto-coding (MedDRA, WHO-DD), narrative writing (NLP/ML), translation, trend analysis, image interpretation, document parsing (OCR/NLP). 4) Product/Event Dictionaries: Manage health products, substances, admin routes, MedDRA, IMDRF/UDI, VEDDRA. 5) Signal Detection: Biostatistical algorithms (PRR, ROR, EBGM, BCPNN, etc.) for all product types (orthodox, biological, medical devices, IVDs, veterinary, complementary). 6) Aggregate Reporting: Dashboards, configurable queries, templated reports (DSUR, PADER, CIOMS II), data filtering. 7) Vigilance Activities: PI/PIL, DHCPL, risk management plans, PSUR/PBRER, PV inspections, PSMF, QPPV info. 8) Regional Decentralization: Isolate ICSRs/data by region with access controls. 9) Interoperability: REST APIs (VigiMobile, MedSafety), MedDRA/SNOMED, WHO-DD, AMA, NDOH/NHI, IMDRF, VigiBase. Non-functional: Cloud hosting (SOC-3, ISO9001/27001, POPIA-compliant), security (GxP, CFR 21 Part 11, EU Annex 11), usability (PWA, multi-language, audit trails, e-signatures), performance (minimal latency). Modular implementation: Base platform (Modules 1–6) for all health product categories, with veterinary phase-in. Maintenance: 36-month Tier 3 support.

Pricing: 80/20 preference point system (Price 80, Specific Goals 20). Total scoring: 100 points (Functionality 40, Presentation 40, Price/Specific Goals 20). Pricing schedule must be completed per Section B 5 (SBD 3.1) and included in sealed bid. Breakdown required: modular costing for base platform (Modules 1–6) and per health product category (orthodox/biological, medical devices/IVDs, veterinary, complementary). Include data standardization support (up to 60 hours/category). Detail project milestones, payment points, and modular approach. Maintenance/support costs for 36 months (Tier 3) must be itemized. No posted/email bids accepted; all pricing documents must be submitted physically with bid.

Mandatory compliance: Prevention and Combating of Corrupt Activities Act adherence. B-BBEE: Preference points (20) awarded per Preferential Procurement Regulations, 2022 (SBD 6.1 form required). Bid documents must include: SBD 1 (Invitation to Bid), SBD 4 (Declaration of Interest), SBD 6.1 (Preference Points Claim). Accept General Conditions of Contract (GCC). All bids must be originally signed in ink or certified copies. Documents must be stamped and signed by a commissioner of oaths where required. Bid validity: 90 days from closing date.