Quality Management System (QMS) for the Regional Pharmacy in Region Midtjylland

Region Midtjylland

The Hospital Pharmacy intends to procure a new Quality Management System (QMS) to support and manage its GxP-regulated quality processes. The solution shall be a standard, modular and cloud-based SaaS solution supporting key quality processes, including change management, deviations, CAPA, complaints, recalls, training and supplier management.

Deadline

Deadline 2026-12-14

Hvem? Hvad? Hvor?
Indkøbshistorik
Dato Dokument
2026-11-09 Udbudsbekendtgørelse
Udbudsbekendtgørelse (2026-11-09)
Objekt
Omfanget af udbuddet
Titel: Quality Management System (QMS) for the Regional Pharmacy in Region Midtjylland
Referencenummer: 1-23-4-72-51-26
Kort beskrivelse:
The Hospital Pharmacy intends to procure a new Quality Management System (QMS) to support and manage its GxP-regulated quality processes. The solution shall be a standard, modular and cloud-based SaaS solution supporting key quality processes, including change management, deviations, CAPA, complaints, recalls, training and supplier management.
Vis mere
Kontrakttype: Varer
Produkter/tjenester: Programpakke til overensstemmelsesprøvning 📦
Anslået værdi uden moms: 5 500 000 DKK 💰
Supplerende kontrakttype: Tjenesteydelser
Beskrivelse
Intern ID: 1-23-4-72-51-26
Yderligere oplysninger:
The procurement documents, including the tender conditions, are published via Mercell’s internet-based procurement system, “CTM”. Accordingly, the procurement documents, including any corrigenda, may be downloaded via https://eu.eu-supply.com/ctm/supplier/publictenders?B=REGIONMIDT. All communication concerning this procurement procedure must take place via CTM in accordance with the tender conditions and not via the Contracting Authority’s email address stated above. Access to the procurement documents and participation in the procurement procedure require online registration in CTM. Registration as a user of the system is free of charge. Once registered, the Tenderer must log in via the upper left-hand corner. An overview of all procurement procedures conducted by the Region will then be displayed. The relevant procurement procedure should be selected, after which the procurement documents will become available, including the appendices to be submitted as part of the complete tender. Please note that all actions taken by both the Contracting Authority and the [Tenderer/Applicant] are logged in the system. For technical questions concerning the use of the system, please contact Mercell Support by telephone on +45 70 20 80 14. Questions concerning the procurement procedure itself must be submitted to the Contracting Authority via the questions and answers module in the system. The answers to such questions will be published in anonymised form in the system and will be accessible to all participants.
Vis mere
Yderligere produkter/tjenester:
+ 5 mere
Land: Danmark 🇩🇰
Sted for udførelsen: Østjylland 🏙️
Kriterier for tildeling
Pris ✅
Pris (justeringskoefficient): 40
Kvalitetskriterium (navn): Quality
Kvalitetskriterium (vægtning): 45
Kvalitetskriterium (navn): Detailed time schedule
Kvalitetskriterium (vægtning): 15
Titel
Partiets identifikationsnummer: LOT-0000

Procedure
Type af procedure
Åben procedure ✅
Retsgrundlag: Direktiv 2014/24/EU
Administrative oplysninger
Frist for modtagelse af bud eller ansøgninger om deltagelse: 2026-12-14 11:00:00 📅
Betingelser for åbning af tilbud (Oplysninger om bemyndigede personer og åbningsprocedure):
Tenders will be opened in the electronic tendering system. Tenderers will not be permitted to attend the opening of tenders.
Sprog, på hvilke bud eller ansøgninger om deltagelse kan indgives: engelsk 🗣️
dansk 🗣️
Minimumsfrist, inden for hvilken tilbudsgiveren skal opretholde tilbuddet: 6 måneder
Udbudsbetingelser
Tilbudsgivere kan indgive mere end ét tilbud
Yderligere oplysninger:
Tenders will be opened in the electronic tendering system. Tenderers will not be permitted to attend the opening of tenders.
Elektronisk fakturering: Påkrævet
Der vil blive anvendt elektronisk bestilling ✅
Der vil blive anvendt elektronisk betaling ✅
Kriterier for tildeling
Vægtningstype: Vægtning (procentdel, præcis)
Udbudsbetingelser
Kontrakten indeholder gennemførelsesbetingelser ✅

Juridiske, økonomiske, finansielle og tekniske oplysninger
Betingelser for deltagelse
Udvælgelseskriterium: Generel årlig omsætning
Liste og kortfattet beskrivelse af regler og kriterier:
It is a minimum requirement that the total annual turnover, i.e. the net turnover for the most recent financial year, amounts to at least DKK 10,000,000. Documentation requirements regarding annual turnover: As documentation of the amount of net turnover, the successful Tenderer must submit the following, depending on the category of company to which the Tenderer belongs: If the Tenderer is subject to statutory audit requirements: - If net turnover is stated in the annual reports: Approved annual reports accompanied by an auditor's report. - If net turnover is not stated in the annual reports: An auditor's review report or audit report confirming the amount of net turnover. If the Tenderer is not subject to statutory audit requirements: Either approved annual reports accompanied by an auditor's report or review report, or an auditor's review report confirming the amount of net turnover.
Vis mere
Udvælgelseskriterium: Referencer på specificerede leverancer
Liste og kortfattet beskrivelse af regler og kriterier:
It is a minimum requirement that the Tenderer has relevant experience in the form of at least one comparable reference within the past three years. A reference is considered comparable if it concerns the delivery of a QMS system to customers with pharmaceutical production under EU GMP regulation As documentation of the Tenderer's relevant experience, the successful Tenderer must submit a signed reference list. The Contracting Authority reserves the right to contact the listed references to verify the accuracy of the information provided.
Vis mere
Betingelser i forbindelse med kontrakten
Betingelser for opfyldelse af kontrakten:
If the contract is awarded to a group of economic operators (e.g. a consortium), the members of the group must assume joint and several liability and appoint a common authorised representative, see also appendix E.
Betingelser for deltagelse
Udelukkelsesgrund:
Afgivelse af urigtige oplysninger, tilbageholdelse af oplysninger, ude af stand til at fremlægge de dokumenter, der anmodes om, eller indhentede fortrolige oplysninger i forbindelse med denne procedure
Aftaler med andre økonomiske aktører med henblik på konkurrencefordrejning
Aktiver, der administreres af en kurator
+ 19 mere
Alvorlige forsømmelser i forbindelse med udøvelsen af erhvervet
Børnearbejde og andre former for menneskehandel
Deltagelse i en kriminel organisation
Direkte eller indirekte involvering i forberedelsen af denne udbudsprocedure
En situation, der svarer til konkurs i henhold til national ret
Erhvervsvirksomheden er indstillet
Hvidvaskning af penge eller finansiering af terrorisme
Insolvens
Interessekonflikt som følge af deltagelse i udbudsproceduren
Konkurs
Korruption
Svig
Terrorhandlinger eller strafbare handlinger med forbindelse til terroraktivitet
Tilsidesættelse af forpligtelser på det arbejdsretlige område
Tilsidesættelse af forpligtelser på miljølovgivningsområdet
Tilsidesættelse af forpligtelser på sociallovgivningsområdet
Tilsidesættelse af forpligtelser vedrørende betaling af bidrag til sociale sikringsordninger
Tilsidesættelse af forpligtelser vedrørende betaling af skatter og afgifter
Tvangsakkord uden for konkurs
Beskrivelse af udelukkelsesgrunde:
Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for…
… corruption, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 3 of the Convention on the fight against corruption involving officials of the European Communities or officials of Member States of the European Union, OJ C 195, 25.6.1997, p. 1, and in Article 2(1) of Council Framework Decision 2003/568/JHA of 22 July 2003 on combating corruption in the private sector (OJ L 192, 31.7.2003, p. 54). This exclusion ground also includes corruption as defined in the national law of the contracting authority (contracting entity) or the economic operator
… fraud, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? Within the meaning of Article 1 of the Convention on the protection of the European Communities' financial interests (OJ C 316, 27.11.1995, p. 48).
… money laundering or terrorist financing, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 1 of Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (OJ L 309, 25.11.2005, p. 15).
… participation in a criminal organisation, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 2 of Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime (OJ L 300, 11.11.2008, p. 42).
… terrorist offences or offences linked to terrorist activities, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Articles 1 and 3 of Council Framework Decision of 13 June 2002 on combating terrorism (OJ L 164, 22.6.2002, p. 3). This exclusion ground also includes inciting or aiding or abetting or attempting to commit an offence, as referred to in Article 4 of that Framework Decision.
… child labour and other forms of trafficking in human beings, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 2 of Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims, and replacing Council Framework Decision 2002/629/JHA (OJ L 101, 15.4.2011, p. 1).
Has the economic operator, to its knowledge, breached its obligations in the field of…
… environmental law? As referred to for the purposes of this procurement in national law, in the relevant notice or the procurement documents or in Article 18(2) of Directive 2014/24/EU.
… labour law? As referred to for the purposes of this procurement in national law, in the relevant notice or the procurement documents or in Article 18(2) of Directive 2014/24/EU.
… social law? As referred to for the purposes of this procurement in national law, in the relevant notice or the procurement documents or in Article 18(2) of Directive 2014/24/EU.
Has the economic operator entered into agreements with other economic operators aimed at distorting competition?
Is the economic operator guilty of grave professional misconduct? Where applicable, see definitions in national law, the relevant notice or the procurement documents.
Can the economic operator confirm that:a) It has been guilty of serious misrepresentation in supplying the information required for the verification of the absence of grounds for exclusion or the fulfilment of the selection criteria,b) It has withheld such information,c) It has not been able, without delay, to submit the supporting documents required by a contracting authority or contracting entity, andd) It has undertaken to unduly influence the decision making process of the contracting authority or contracting entity, to obtain confidential information that may confer upon it undue advantages in the procurement procedure or to negligently provide misleading information that may have a material influence on decisions concerning exclusion, selection or award?
Vis mere
Is the economic operator aware of any conflict of interest, as indicated in national law, the relevant notice or the procurement documents due to its participation in the procurement procedure?
Has the economic operator or an undertaking related to it advised the contracting authority or contracting entity or otherwise been involved in the preparation of the procurement procedure?
Has the economic operator breached its obligations relating to the payment…
… social security contributions, both in the country in which it is established and in Member State of the contracting authority or contracting entity if other than the country of establishment?
… of taxes, both in the country in which it is established and in Member State of the contracting authority or contracting entity if other than the country of establishment?
Are the business activities of the economic operator suspended? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract.
Vis mere
Is the economic operator bankrupt? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract.
Vis mere
Is the economic operator in arrangement with creditors? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract.
Vis mere
Is the economic operator the subject of insolvency or winding-up? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract.
Vis mere
Are the assets of the economic operator being administered by a liquidator or by the court? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract.
Vis mere
Is the economic operator in in any analogous situation like bankruptcy arising from a similar procedure under national laws and regulations? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract.
Vis mere

Ordregivende myndighed
Navn og adresser
Navn: Region Midtjylland
Nationalt registreringsnummer: 29190925
Afdeling: Indkøb & Medicoteknik
Postadresse: Olof Palmes Allé 15
Postnummer: 8200
Postby: Aarhus N
Region: Østjylland 🏙️
Land: Danmark 🇩🇰
Enhed: Jeppe Askhim
E-mail: jepask@rm.dk 📧
Telefon: +45 24619491 📞
URL: https://www.rm.dk/om-os/info-til-samarbejdspartnere/udbud/ 🌏
Køberprofilens adresse: https://eu.eu-supply.com/ctm/company/companyinformation/index/253854 🌏
Den ordregivende myndigheds type
Regional eller lokal myndighed
Hovedaktivitet
Sundhed
Kommunikation
URL til dokumenter: https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=461612&TID=200421964&B= 🌏
URL for deltagelse: https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=461612&TID=200421964&B= 🌏
ID for den foregående bekendtgørelse: 393134-2026
Elektronisk indgivelse: Tilladt

Supplerende oplysninger
Yderligere oplysninger
The procurement documents, including the tender conditions, are published via Mercell’s internet-based procurement system, “CTM”. Accordingly, the procurement documents, including any corrigenda, may be downloaded via https://eu.eu-supply.com/ctm/supplier/publictenders?B=REGIONMIDT. All communication concerning this procurement procedure must take place via CTM in accordance with the tender conditions and not via the Contracting Authority’s email address stated above. Access to the procurement documents and participation in the procurement procedure require online registration in CTM. Registration as a user of the system is free of charge. Once registered, the Tenderer must log in via the upper left-hand corner. An overview of all procurement procedures conducted by the Region will then be displayed. The relevant procurement procedure should be selected, after which the procurement documents will become available, including the appendices to be submitted as part of the complete tender. Please note that all actions taken by both the Contracting Authority and the [Tenderer/Applicant] are logged in the system. For technical questions concerning the use of the system, please contact Mercell Support by telephone on +45 70 20 80 14. Questions concerning the procurement procedure itself must be submitted to the Contracting Authority via the questions and answers module in the system. The answers to such questions will be published in anonymised form in the system and will be accessible to all participants.
Vis mere
Gennemgå organ
Navn: Klagenævnet for Udbud
Nationalt registreringsnummer: 37795526
Postadresse: Nævnenes Hus, Tolboden 2
Postnummer: 8800
Postby: Viborg
Region: Vestjylland 🏙️
Land: Danmark 🇩🇰
E-mail: klfu@naevneneshus.dk 📧
Telefon: +45 72405600 📞
URL: https://naevneneshus.dk/naevnsoversigt/klagenaevnet-for-udbud/ 🌏
Tjeneste, hvorfra der kan indhentes oplysninger om klageproceduren
Navn: Konkurrence- og Forbrugerstyrelsen
Nationalt registreringsnummer: 10294819
Postadresse: Carl Jacobsens Vej 35
Postnummer: 2500
Postby: Valby
Region: Københavns omegn 🏙️
E-mail: kfst@kfst.dk 📧
Telefon: +45 41715000 📞
URL: https://kfst.dk/udbud 🌏
Gennemgangsprocedure
Præcise oplysninger om fristerne for gennemgangsprocedurer:
A complaint must be submitted to the Danish Complaints Board for Public Procurement within 45 calendar days after the contracting entity has published a notice in the Official Journal of the European Union stating that the contracting entity has entered into a contract, and within 6 months after the contracting entity has entered into a framework agreement, calculated from the day after the date on which the contracting entity notified the affected candidates and tenderers. At the same time as the complaint is submitted to the Danish Complaints Board for Public Procurement, the complainant must send a copy of the complaint, including any appendices, to the contracting entity, preferably by email.
Vis mere
Oplysninger om elektroniske arbejdsgange
Elektronisk fakturering vil blive accepteret
Kilde: OJS 2026/S 219-784367 (2026-11-09)
Nye indkøb inden for beslægtede kategorier 🆕
Relaterede søgninger 🔍
Region:
Danmark Danmark Hovedstaden Københavns omegn Midtjylland Vestjylland Østjylland
Produkter/tjenester:
Programpakker og informationssystemer Branchespecifik programpakke Programpakke til overensstemmelsesprøvning It-tjenester: rådgivning,... Programmering af software og konsulentvirksomhed Programmelrelaterede tjenester Programmelsupport Implementering af programmel Konfigurering af programmel Programmelvedligeholdelses- og...