Procurement Summary
Country : Brazil
Summary : Hiring of Computerized Systems Validation Services, at the Radiopharmacy Center of the Institute of Energy and Nuclear Research, According to Conditions, Quantities and Requirements Established...
Deadline : 24 Nov 2022
Other Information
Notice Type : Tender
TOT Ref.No.: 74467258
Document Ref. No. : 84/2022
Competition : ICB
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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Purpose: Electronic Auction - Hiring of Computerized Systems Validation Services, at the Radiopharmacy Center of the Institute of Energy and Nuclear Research, according to the conditions, quantities and requirements established in this Public Notice and its annexes
UASG Code: 113202
Public Notice fromand : 11/10/2022 from 8:00 am to 11:30 am and from 12:30 pm to 4:30 pm
Submission of Proposal : from 11/10/2022 at 8:00 am
Computerized Systems Validation Service, at the Radiopharmacy Center of the Institute for Energy and Nuclear Research, including: a) Diagnostic audit with survey of492584800e8c8d91eb93b064ebe674eband gaps in relation to current standards and guides for Validation of Computerized Systems; issuance of a report and elaboration of an action plan. Audit object: 09 (nine) legacy systems b) Validation of the following legacy Computerized Systems; c) Elaboration/Revision of general documents ofand Validation of Computerized Systems at the Radiopharmacy Center; d) Training for two (02) groups, for up to twenty (10) people in total, with the objective of training professionals to understand the validation processes of computerized systems in Pharmaceutical Industries, based on the requirementsCurrent regulatory ies and current guides from the National Health Surveillance Agency (ANVISA), in the Code of Federal Regulations (CRF) Title 21 Part 11 of the Food and Drug Administration (FDA) and in the Good Automated Manufacturing Practices v5 (GAMP 5).
Quantity : 1267d73f7cdfbc6b97a3398f07d475a1fe
Documents
Tender Notice