Stage 1: Qualification Phase, FMS System for Measuring and Monitoring Particles, Temperature and Humidity in Production Rooms in Sykehusapotekene HF

Sykehusapotekene HF

The aim of the procurement is to cover the contracting authority's need for monitoring production equipment and rooms with sufficient operational reliability. The need for monitoring mainly comes from laws and standards that apply for the production of medicines. There must also be an allowance for future needs such as an increase in the number of sensors, new locations, etc.
Monitoring equipment suitable for pharmaceutical production applies for this procurement and the use of the term FMS.
Click here https://permalink.mercell.com/133205263.aspx

Frist

Fristen for mottak av tilbud var 2020-08-28. Anskaffelsen ble publisert 2020-06-24.

Hvem? Hva? Hvor?
Anskaffelseshistorikk
Dato Dokument
2020-06-24 Kunngjøring av konkurranse
Kunngjøring av konkurranse (2020-06-24)
Gjenstand
Anskaffelsens omfang
Tittel: Medical information systems
Referansenummer: 2020-0012
Kort beskrivelse:
The aim of the procurement is to cover the contracting authority's need for monitoring production equipment and rooms with sufficient operational reliability. The need for monitoring mainly comes from laws and standards that apply for the production of medicines. There must also be an allowance for future needs such as an increase in the number of sensors, new locations, etc. Monitoring equipment suitable for pharmaceutical production applies for this procurement and the use of the term FMS. Click here https://permalink.mercell.com/133205263.aspx
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Metadata for kunngjøring
Originalspråk: engelsk 🗣️
Dokumenttype: Kunngjøring av konkurranse
Kontraktens art: Varer
Forskrift: Det europeiske økonomiske samarbeidsområdet (EØS)
Felles innkjøpsordliste (CPV)
Kode: Medisinske informasjonssystemer 📦
Tilleggs-CPV: Datalagring 📦
Utførelsessted
NUTS-region: Oslo og Akershus 🏙️

Prosedyre
Prosedyretype: Konkurranse med forhandling
Tilbudstype: Innlevering for alle delkontrakter
Tildelingskriterier
Det mest økonomisk fordelaktige tilbudet

Oppdragsgiver
Identitet
Land: Norge 🇳🇴
Type tildelende myndighet: Nasjonalt eller føderalt byrå/kontor
Navn på tildelende myndighet: Sykehusapotekene HF
Postadresse: Stenersgate 1, postkasse 79
Postnummer: 0050
Poststed: Oslo
Kontakt
Internettadresse: https://permalink.mercell.com/133205263.aspx 🌏
E-post: anders.stedding.kristiansen@sykehusapotekene.no 📧
Telefon: +47 23135214 📞
URL for dokumenter: https://permalink.mercell.com/133205263.aspx 🌏
URL for deltakelse: https://permalink.mercell.com/133205263.aspx 🌏

Referanse
Datoer
Sendt dato: 2020-06-24 📅
Innleveringsfrist: 2020-08-28 📅
Publiseringsdato: 2020-06-26 📅
Startdato: 2020-12-15 📅
Sluttdato: 2024-03-01 📅
Identifikatorer
Kunngjøringsnummer: 2020/S 122-300336
OJ-S-utgave: 122

Gjenstand
Anskaffelsens omfang
Kort beskrivelse:
The aim of the procurement is to cover the contracting authority's need for monitoring production equipment and rooms with sufficient operational reliability. The need for monitoring mainly comes from laws and standards that apply for the production of medicines. There must also be an allowance for future needs such as an increase in the number of sensors, new locations, etc.
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Monitoring equipment suitable for pharmaceutical production applies for this procurement and the use of the term FMS.
Estimert totalverdi: 2 000 000 NOK 💰
Kort beskrivelse:
The existing system is described in SSA-K Annex 3: the contracting authority's technical platform. The current sensors are installed with cabled transfer of signal. We would therefore like a system that reads and processes data from the sensors and that can use the existing infrastructure in the form of a wire/contact network, possibly individual sensors to the degree that this is possible.
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Alternatively, a new FMS system can be used with a wireless and/or cloud based system. The contracting authority understands that fewer sensors can be reused in this case. Wireless sensor technology is particularly interesting with a view to expansions.
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It is preferable that the monitoring system is connected to different sensors for measuring particle counts and other environmental factors. It is a prerequisite that these have a compatible signal.
The annexes 'SSA-K Annex 1 The Contracting Authority's Requirement Specifications' and 'SSA-K Annex 3 The Contracting Authority's Technical Platform' detail the procurement. The description below is meant to be a simple summary.
The FMS system must continually read and save data from connected sensors and give a warning if the measurements are outside the stated limits. It is also important that the system can present historical data and generate reports in a way that is suitable for documenting medicine production. In order to achieve this, the system must be operating as much as possible with short correction periods in the event of interruptions. SAHF would like a system that can handle the sensors that are mandatory to use in medicine production. These sensors are described in the annexes mentioned above.
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SAHF would like to have the option to enter into a continual service contract for technical help and annual calibrations of relevant sensors (particle counters, temperature, dampness, pressure, and humidity sensors). Furthermore, we would like tenderers to provide parts for any expansions, replacements and repairs.
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It would be advantageous for employees in the hospital pharmacies if the offered systems are user friendly. The contracting authority would like references to be listed for the tenderer's offered systems.
The system can be based on servers located in a computer centre operated by SAHF and/or cloud based systems to the degree that such a system can also cover the need.
The equipment must be delivered and installed at the following address for the hospital pharmacy Oslo, Rikshospitalet:
Sognsvannsveien 20, 0372 Oslo.
The equipment must be delivered and installed at the following address for the option hospital pharmacy Lørenskog, AHUS:
Sykehusveien 25, 1478 Nordbyhagen.
We would like quick commissioning after the contract is signed.
Tenderers must submit a proposal for a progress plan for the delivery, installation and testing/qualification. The final plan for delivery will be determined after approval from the contracting authority.
The procurement will primarily require the delivery of a complete system, installation, documentation and training. It must also cover the after sales need for the hospital pharmacies. Two contracts (SSA-K and SSA-V) will therefore form the basis of the contract with primarily one tenderer. The same will apply if SAHF would like to reuse individual components and meters from the current system.
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Estimert verdi eksklusive mva: 2 000 000 NOK 💰
Beskrivelse av opsjoner:
If the option for an equivalent delivery for AHUS is taken up, it will be at the latest 2 years from the date the SSA-K contract text page 2 is signed.

Juridisk, økonomisk, finansiell og teknisk informasjon
Vilkår for deltakelse
Egnethet til å utøve yrkesvirksomheten:
Qualification requirement:
K1/ Tenderers must be a legally registered company.
Documentation requirement:
K1: A company registration certificate or equivalent documentation that shows that the tenderer is registered in a register of business enterprises, a trade register, or a register of commerce in their home country.
Økonomisk og finansiell stilling:
Qualification requirement:
K2/ Tenderers must have adequate economic and financial capacity to fulfil their obligations under the contract.
Minste nivå(er) av standarder:
Documentation requirement:
K2: The economic and financial standing must be documented by the following information:
(a) the last approved annual accounts with the annual report and the auditor's report. The preliminary accounting figures for 2019 are requested, possibly recent relevant information can also be presented;
(b) solidity assessment from a company with a licence to run a credit information company. The evaluation must not be older than 6 months at the time of the application deadline, it must be based on the last approved fiscal figures and should report on the credit worthiness and degree of bankruptcy risk (bankruptcy prediction).
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Teknisk og faglig kapasitet:
Qualification requirement:
K3 Tenderers must have good competence and capacity for the delivery of an FMS system.
K4 Tenderers must have experience from the delivery and maintenance of an FMS system
K5 Tenderers must have established satisfactory methods for information security.
K6 Tenderers must have established satisfactory environmental management systems.
K7 Tenderers must have established satisfactory quality assurance systems.
Minste nivå(er) av standarder:
K3:
Tenderers' organisational and technical capacity shall be documented with the following information:
(a) a description of the tenderer's organisation relevant for this delivery, as well as the management's relevant qualifications.
(b) a description of the total competence and capacity that the tenderer has available for the establishment, delivery, maintenance, and further development of the FMS system. Tenderers are asked to present an overview of the number of resources that are available, with a statement of relevant education, technology and product certificates, other relevant certificates, and the resources' experience with relevant technologies with the associated validation.
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(c) there must be a specification of which resources (the number of employees as well as a statement of relevant competence/experience) belong to the tenderer and which belong to other companies.
K4:
A description of the most important deliveries in the last 3 years that are relevant and comparable to the current procurement. The documentation for each delivery must state:
(a) the customers' name and contact information.
(b) a detailed description of the delivery, including the scope, value and duration. Particular information is to be given on the extent to which the delivery included a physical delivery and/or delivery of an FMS system/equivalent system for measuring particles, temperature and humidity, as well as characteristics of the customer/delivery, locations and users. A short description of why the tenderer considers the reference relevant for this procurement.
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(c) information on the extent to which executing key personnel will be available for SAHF, and possibly to what degree the delivery will be carried out in cooperation with, or by, collaborating companies.
K5:
A copy of an information security certificate (ISO27001/equivalent), issued by an accredited certification body.
Alternatively, a description can be given of the tenderer's systems for information security, as well as how they are implemented and managed in the company.
The requirement must be fulfilled by both the tenderer and any collaborating companies.
K6:
A copy of an information security certificate (ISO14001/EMAS/Environmental Lighthouse/equivalent), issued by accredited certification bodies.
Alternatively, a description can be given of the tenderer's systems for environmental management, as well as how they are implemented and managed in the company.
K7:
A copy of a quality assurance certificate (ISO 9001/equivalent), issued by an accredited certification body.
Alternatively, a description can be given of the tenderer's systems for quality assurance, as well as how they are implemented and managed in the company.

Prosedyre
Rettslig grunnlag: 32014L0024
Tidspunkt for mottak av tilbud: 12:00
Dato for utsendelse av invitasjoner: 2020-09-04 📅
Språk som tilbud eller forespørsler om deltakelse kan sendes inn på: dansk 🗣️
engelsk 🗣️
+ 2 til norsk 🗣️
svensk 🗣️

Oppdragsgiver
Identitet
Nasjonalt registreringsnummer: 992281618
Kontakt
Kontaktpunkt: Anders Stedding Kristiansen
Adresse til kjøperprofilen: http://www.sykehusapotekene.no/ 🌏
URL for dokumenter: https://permalink.mercell.com/133205263.aspx 🌏

Utfyllende informasjon
Klageinstans
Navn: Oslo Tingrett
Postadresse: C. J. Hambros plass 4
Poststed: Oslo
Postnummer: 0164
Land: Norge 🇳🇴
Kilde: OJS 2020/S 122-300336 (2020-06-24)
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