Quality Management System (QMS) for the Regional Pharmacy in 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.

CPV-Code

48170000

Angebotsfrist

14. Dez 2026, 11:00

Geschätzter Wert

5.500.000 DKK

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.

Losbezug: LOT-0000

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.

Losbezug: LOT-0000

See the tender specifications and appendix 5.a

Losbezug: LOT-0000

See the tender specifications and appendix 2 and 2.a

Losbezug: LOT-0000

See the tender specifications and appendix 1 and 1.a

Losbezug: LOT-0000

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

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 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).

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 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).

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 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).

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 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.

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 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.

Has the economic operator, to its knowledge, breached its obligations in the field of 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.

Has the economic operator, to its knowledge, breached its obligations in the field of 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?

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?

Has the economic operator breached its obligations relating to the payment 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.

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.

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.

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.

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.

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.