WHAT’S IMPORTANT FOR US
SOCIAL RESPONSIBILITY AND INTEGRITY
PQE is an entity highly integrated in the economy and the society in which it operates.
We are expected to be sensitive to social and environmental issues, to be men and women socially and ethically responsible.
We believe that each person shall always respect the law, human rights, and support the fair and safe working conditions, while promoting actions compatible with the environment.
“Since the foundation of PQE, I have strongly believed that our core values, know-how, people and ethics, can make PQE the market leader for sustainable compliance solutions in Europe and beyond. As a matter of fact, we are growing year by year thanks to a full time workforce of dedicated employees, which allows us to enhance our robust and standardized commitment to excellence. Our passion for the growth and development of life science companies enables PQE to consistently exceed our customer’s expectations. This is the reason why we have successfully completed thousands of projects around the world, working in more than 20 different languages.”
Gilda D’Incerti, CEO PQE Group
PQE Group (including Pharma Quality Europe S.r.l. and the relevant Subsidiaries) is a company that provides consultancy and services, which derives precise ethical, and legal, responsibilities towards corporate customers, institutions and communities in which these companies operate.
As the central value of PQE’s culture and behaviour, the concept of “integrity” is the main importance for all stakeholders (ownership, employees, consultants, customers, suppliers, business partners, etc.).
In order to achieve this goal, PQE is required to continuously operate in a context of unbiased competition, fairness and good faith, while respecting the legitimate interests of all stakeholders, as well as in conformity of the laws of the countries where the sites, and activities, are located. Hence, the need for all individuals involved in working or collaborating with PQE, to adhere to these ethical and behavioural principles and enforce them as part of their duties and responsibilities.
In addition to a pure moral values, this intention takes on the evidence of a strong corporate characterisation and ensures the stability of the context in which PQE has to operate.
The importance of the ethical subject has resulted in PQE’s management clearly defining the values and responsibilities both internally and externally. For this reason this Ethical Code has been developed. It also acts as an Internal Regulation, whose knowledge and compliance by all employees, collaborators and partners become critical factors to the proper internal functioning and the positioning of the company towards its customers.
This document has been prepared to explain the basic elements of our corporate culture, as well as the behavioural standards in the business management and in the implementation of various business activities. As a matter of fact, it constitutes the official document where the Ethical Values, in which PQE identifies itself, are established. PQE also undertakes to respect these values and ensures that the various people / companies with whom it trades (hereinafter identified as subjects addressed) coherently respect them as well.
The company therefore requires its employees and collaborators to continuously demonstrate the sense of belonging to the company’s ethics that is expressed through a supportive behaviour towards both the entire group and the employer.
Furthermore, the implementation of the code comes from the desire to:
- express the commitments and ethical responsibilities to be followed in business and corporate activities management by all professionals;
- involve its resources in a process of individual moral growth and awareness, by creating a positive work environment, where people can grow and succeed;
- increase, expand and highlight the value of the “team work”, in order to achieve common goals;
- set the behavioural standard and the relative disciplinary criteria, aimed at preventing violations associated with the company’s activities;
- identify appropriate measures and instruments of internal control to monitor the respect of the Code and to bring out every possible form of improvement;
- fully protect the patient and / or customer by ensuring that the service provided bring concrete benefits.
The Code of Ethics is a constantly evolving document and all subjects addressed are requested to contribute to its evolution and its improvement.
3. Ethical Principles
3.1 Core Values
- Consistent behaviours with management practices, operational goals, social responsibility and ethical values are part of the corporate identity;
- Management begins with health and safety at work, which is the first responsibility towards the collaborators;
- The management team knows and fulfils the best safety practices in the workplace and trains its staff in full compliance with these practices;
- The management model is designed and is derived from the obligations generated by the company’s policy, by its culture and the commitments of this Code;
- Listening, engaging, informing and training are all essential elements for all employees and collaborators;
- An error, declared and not hidden, is an opportunity for the reflection oriented to the search for continuous improvement;
- The active opposition of ideas and opinions is a positive opportunity for discussion, verification and analysis;
- The company has always worked to maintain a work environment that values the contribution and role of each employee and collaborator and which takes account of their aspirations;
- The company considers the physical, social, cultural and behavioural differences, and it collaborates in the integration and value of the most vulnerable and disadvantaged subjects;
- The company promotes the active participation of all employees and collaborators even through social relations and conviviality occasions;
- The company is particularly attentive to its employees and collaborators needs in creating structures of reasonable satisfaction;
- The management team creates opportunities and occasions to share corporate objectives;
- Practical and commercial activities are not eliminated from ethical commitment.
3.2 Human Rights
In perfect alignment with the Universal Declaration of Human Rights, PQE respects the fundamental rights of every individual, protecting the moral integrity and ensuring equal opportunities.
Therefore, PQE does not allow any form of isolation, exploitation and/or harassment and discrimination due to personal or work reasons, diversity of race, language, colour, faith or religion, political affiliation, nationality, ethnicity, age, gender, sexual orientation, marital status, inability, disability and/or physical appearance, social and economic condition.
3.3 Ethical Conduct in Business
The respect of ethical standards and transparency in the conduct of business are necessary conditions, as well as a competitive advantage, to pursue and achieve the defined company’s goals.
PQE therefore bases its actions on respect for basic principles, such as:
- Transparency and clarity of information;
- Social responsibility;
- Respect for and the protection of people;
- Fairness in competition and commercial comparison.
3.3.1 Communication, Transparency and Clarity of Information
The company is a system of continuous production of knowledge; the internal communication is therefore the natural instrument for the circulation, spread and sharing of the produced knowledge. Fundamental content of PQE’s communication is the promotion and support of the commitments defined by this Code of Ethics. To the various communication operators an updated, continuous and complete information is guaranteed, in the forms that make it possible for in-depth examination of the themes in an atmosphere of clarity and constructive confrontation.
3.3.2 Moral Integrity
PQE engages to provide an impartial action, to avoid preferential treatments as well as disparities in service, to refrain from putting and / or succumb to undue pressures by taking initiatives and decisions with the utmost transparency, avoiding to create or benefit from situations of privilege.
All subjects addressed in this document are requested to adhere the laws and regulations, of the Code of Ethics and the company’s internal rules, apply them with honesty and fairness, avoid conflicts of interest between personal, business and customer’s goals.
All subjects shall be aware that services delivered by PQE are ultimately oriented to ensure the Patient Safety and the Product Quality.
Any operations executed by the PQE shall preserve data integrity ensuring that information is attributable, legible, contemporaneous, original and accurate since Patient Safety and the Product Quality relies on robust records.
3.3.5 Social Responsibility
Health safeguard is an integral part of PQE’s corporate mission since the company includes in its value’s construction chain relevant for health purposes. For this reason, it discusses these issues with the institutions and the various organizations of the civil society and provides expert advice, along with useful professional contributions for the achievement of goals in the field of life science. The company promotes and supports social, cultural and, where possible, solidarity initiatives, within the sector in which it operates.
3.3.6 Respect for and protection of the people, transparency
PQE evaluates all its employees and collaborators as a primary resource of its work activity, involving them in the company’s business, offering services that improve the life quality and ensuring a working environment based on attention, active listening, trust and professional recognition. The management team informs and shares with the staff the management criteria adopted, making records and documents transparent and accessible. It also protects and safeguards its staff against negative events or external threats, as well as against acts of psychological violence, fighting any discriminatory form or detriment to the person and their ideas.
PQE repudiates all forms of sexual harassment, workplace bullying situations and conducts or verbal expressions that may offend the person.
In order to ensure this context, PQE promotes working conditions that:
- protect the psychological integrity of individuals;
- consider the different aspirations;
- support creativity;
- encourage active participation;
- produce accountability;
- facilitate and improve the capacity / ability to work in teams.
3.3.7 Fairness in competition and commercial comparison
PQE is active in the adoption, compliance and implementation of shared and effective professional behaviour to its own image and the industry in which it operates.
The conduct of all individuals during the performance of their assignments or functions has to be inspired by transparency, fairness and mutual respect as well as loyalty, both in the form and in the substance, according to the current regulations and internal procedures, in order to protect the company heritage and image.
In particular, following attitudes should be avoided:
- the pursuit of personal or third parties interests, to the detriment of those of the company and / or the community;
- the exploitation, in the personal or third party interest, of PQE’s name and reputation, as well as any information and business opportunities acquired while performing duties or function;
- unfair competition;
- actions or omissions in violation to the definitions of this Code.
Each Subject addressed does not accept, or make, any pressures, recommendations or reports, which could harm PQE or cause undue advantages for himself, PQE or third parties.
Each Subject addressed also rejects and does not promise and / or offer money or other undue benefits, unless they are of little value and not related to, or conditioned by, requests of any kind.
If the Subject addressed receives from a third party an offer or a request for benefits, excluding gifts of small value, they will immediately inform their manager or, where applicable, the person to whom they should report such evaluations and actions.
No negative consequence shall derive for anyone who has blown the whistle in good faith. The confidentiality of the whistleblower’s identity shall be ensured. In order to make these whistleblowing actions easier, the procedure described hereunder is operational.
3.4 Health & Safety in the workplace
PQE guarantees the protection and safety in the different work places for its staff and for third parties, committing itself to comply with current regulations and promoting health and safety of all places that form the work environment, even beyond legal requirements expressed by the Italian Law D.Lgs. 81/2008 and by the health and safety legislations applicable in the countries where PQE employs its personnel.
PQE guarantees the protection of personal data of every employee/collaborator. In the event that the latter is forced to provide sensitive and / or personal information, the company guarantees its treatment in compliance with current regulations.
3.6 Equal opportunities and professional development
The chances of employment and / or career advancement resulting, as already mentioned, from the recognition of professional talent and sense of responsibility, from the identification of achievements and competencies expressed, are based on objectivity and transparency criteria, ensuring equal opportunities and avoiding any form of favouritism. PQE’s commitment towards its staff covers both the technical training and the managerial growth.
As part of the integration of new employees/collaborators, PQE is sensitive to the inclusion of new graduates and hires its staff exclusively with a regular contract, not tolerating any form of illegal employment or “moonlighting”. PQE ensures the principle of equal opportunities and it operates on this basis for the career advancement and salary increase, comparing them to the market conditions, and ensuring transparency, reliability, accuracy and clarity of its valuation methods.
PQE contributes to social development combining the pursuit of economic revenue (and therefore the well-being of its employees), while maintaining strong ethical principles in supplying its services.
PQE strongly commits to the creation of new job opportunities, to the care and attention of protected categories and to the support to major social problems.
3.7 Sustainable development and environmental responsibility
As a socially responsible company, PQE believes that its success is tied to the well-being of the community and the environment in which it works and lives.
PQE therefore commits to protecting the environment and the health and safety of its employees.
As part of this commitment, the company complies with the regulations relating to the environment (by implementing, for example, the Legislative Decree 151/2005 of Italian Law on the disposal of electrical and electronic equipment) and it encourages its staff to use its assets with attention, making its staff aware of the proper recycling of waste. PQE in fact seeks to minimize the harmful effects to the environment caused by its activities and to achieve higher goals in relation to the environment.
Responsibility for the environment is one of the criteria observed when evaluating and selecting suppliers.
4. Rules of Conduct
This section details the Rules of Conduct, in order to better identify the behaviour which all individuals who work with PQE must comply with in performing various business activities, while respecting the principles of the Code of Ethics.
4.1 Rules of Conduct in the company
It is all managers’ responsibility to promote the internal communication through an appropriate management of interpersonal relationships with their resources, being a good example and ensuring opportunities for dialogue and listening, both individual and group.
The assumption of responsibility, initiative and spirit of collaboration are inseparable aspects that characterize the activity of each employee/collaborator.
On this basis, PQE considers it essential the application and sharing of certain behavioural rules in the company by all its staff, related both to interpersonal relationships and to the image. In general, PQE requires the adoption of the principles of “good manners enterprise,” as summarized below.
It is forbidden to:
- Use abusive or inappropriate language, both in verbal and in any emotional demonstrations;
- Smoke in the company’s offices or cars;
- Introduce / make use of drugs;
- Disclose and / or possess pornographic material;
- Speak to colleagues in an offensive, threatening, disrespectful, rude manner or without paying attention to the sensitivity of the subject in question, offending the dignity of the person and the company’s image.
It is required to:
- Respect the Company’s Roles and the so-called “chain of command”, meaning a respect for the hierarchy, relating to the organizational structure;
- Keep respectful relationships, based on mutual willingness, kindness, courtesy and, in general, good education;
- Wear appropriate clothes in the working environment, especially when performing an activity with external customers or third parties.
4.1.1 Transparency of accounting
PQE considers it essential to provide transparent, accurate and complete accounting information. For this purpose it endeavours to organise an exact and reliable accounting system, which correctly represents the results of operations and provides the tools to identify, prevent and manage, as far as possible, financial and operational risks, as well as fraud to the company’s or third party’s detriment.
The accounting surveys, and the documents that derive from it, must be based on accurate, complete and verifiable information and must reflect the nature of the operation which they relate to, in accordance with the external constraints (laws, accounting principles), as well as policies, plans, regulations and internal procedures.
The accounting surveys must allow to:
- produce accurate and timely economic situation, patrimonial and financial data intended for both inside and outside the company (balance sheets, supporting material, etc..);
- provide the tools to identify, prevent and manage, as far as possible, financial and operational risks and fraud against the Company;
- check the safeguarding of assets and loss protection.
4.1.2 Conflict of interest
It is necessary to refrain from participating in decision-making, processes or any other activity, which could create conflicts of interest. Those who might learn about a possible conflict of interest, must immediately notify their manager or the company’s management.
4.1.3 Data Integrity
PQE Management is fully committed ensures that all relevant PQE resources are:
- expected to generate reliable data that is, accurate, complete and timely;
- completely accountable for the integrity of data including generation, recording, reporting and retention within his/her own work;
- aware of the importance and potential legal issues of the Regulated data created and maintained by PQE;
- transparent and open reporting of deviations, errors, omissions and aberrant results at all levels of the organization.
PQE personnel shall ensure that Integrity of GxP Data (i.e. data which may have a potential impact on Patient Safety or Product Quality) is preserved at all time.
PQE personnel shall ensure the integrity of GxP records within the delivery of Service, in case of
- Direct creation of GxP Records,
•Validation/Qualification Testing Scripts
- Potential modification of GxP Records maintained by the Systems used by the Customer (e.g. Analytical data maintained by a Laboratory System)
- Review of GxP Records created by Third Party (usually the System Supplier)
All individuals shall be responsible for
- collecting, analyzing, reporting and retaining information and data in a manner that accurately, truthfully and completely represents the activity that occurred
Ensuring the following ALCOA+ attributes for each record which may impact Product Quality and Patient Safety:
• A – attributable to the person generating the data
• L – legible and permanent
• C – contemporaneous
• O – original record (or ‘true copy’)
• A – accurate
• + – complete, consistent, enduring, and available
- Producing and managing documentation that complies with established requirements, current GxP requirements and procedures
- Immediately notifying the relevant PQE Project Manager / Supervisor if they become aware of any potential data integrity issue (including but not limited to, omissions, errors, misconduct or wrongdoing) executed by other colleague(s) or by customers operators
4.1.4 Confidential Information
In the context of the specific activities and responsibilities each employee/collaborator must:
- respect the confidentiality of information acquired while performing his duties, even after the termination of his employment;
- refer only to the documentation which they are authorized to access, using it in compliance with official duties and allowing access only to the people entitled;
- undertake to ensure the disclosure of data by observing the assigned safety measures, keeping the documents entrusted in good order and avoiding to make unnecessary copies, if not in the context and for the purposes of its corporate mission.
None of the employees/collaborators may disclose any internal confidential information, even if they are not directly benefiting from the situation.
In the context of professional fairness required by PQE to carry out the functions and duties assigned to the Employee or Collaborator, each one of them ensures the binding secrecy commitment undertaken, committing themselves in not disclosing to third parties any information, data, documents, communications or other elements received from PQE or its customers or suppliers, without a prior written consent from the owner of the information and / or documentation, and in any case from PQE.
4.1.5 Use of Company Assets
All staff is required to respect the infrastructures, equipment, tools and materials of the Company. Individuals should promptly report to the Internal Supervisory, constituted by the Operation Manager and the Human Resources Manager, if there is any different use of equipment.
All staff is required to use the company’s facilities only for the performance of work tasks.
4.1.6 Non-competition Agreement
For the duration of the contract and for at least six months after the termination of the same, whichever is the cause, the employee/collaborator undertakes not to carry out, either directly or through a third person or entity, activities or transactions on behalf of PQE’s customers and / or companies whose activities can be considered, directly or indirectly, competitive with those carried out by PQE, aware of the exclusivity that their current activities have for PQE, in all areas of expertise.
4.1.7 Allegations Management
According to the relevant Policy, the whistle-blower must communicate any information of alleged wrongdoing about violation of company policy/rules, law, regulation, as well as fraud, and corruption by sending an email to email@example.com. The email is received and read only by the Whistleblowing Board.
4.2 External Relations
PQE considers that it is a fundamental and indispensable value to let the company’s image to come out with clarity, fairness and diligence in all communications and in all relations outside the company.
It strives to establish fair terms of communication, making it not possible to provide false information, manipulate data on the current status and on the expectations of its customers, avoiding the creation of false evaluations and incorrect expectations.
Relations with public institutions, with interest groups, the press and the media and all company’s institutional communications are held exclusively by the responsible in charge of these functions and with the management’s explicit mandate.
The focus of PQE‘s policy is the customer’s satisfaction and the quality of each relationship. PQE aims to be in active collaboration with its customers and engages in anticipating and responding quickly to the changes of their demands, while preserving a culture that encourages the best of each actor in the relationship.
To create and maintain this kind of relationship, PQE’s employees and collaborators undertake to:
- operate in compliance with applicable laws and regulations;
- not discriminate customers, nor exploit a position of strength to their disadvantage;
- always respect the commitments and obligations towards the client;
- adopt to a behavioural style marked by efficiency, collaboration and courtesy;
- provide accurate and complete information in order to allow the customer an informed decision;
- be truthful in advertising communications or of different nature;
- require customers to comply with the principles of its Code of Ethics and, when foreseen by procedures, include in the contracts the express obligation to follow them;
- promptly report to their supervisor any customer behaviour that is contrary to the Ethical Principles of this Code.
If the client is in a non-compliance status as reported by PQE’s employees/collaborators and they decide not to follow the suggested interventions, then it is the employee’s/collaborator’s responsibility to provide a written notification to the client.
4.2.2 Suppliers and Partners
Suppliers and partners play a key role in improving the overall competitiveness of the company and in the pursuit of its objectives.
All suppliers and partners are guaranteed the compliance with the principles of equal opportunities, fairness and impartiality.
Employees and collaborators must select suppliers on the basis of the Ethical Principles of this Code and are encouraged to create and maintain stable, transparent and collaborative relationships with them, acting always in the best interest of the company. Each employee/collaborator must immediately notify their supervisor of any behaviour that seems contrary to the principles expressed in this Code.
4.2.3 Public Administration
The behaviour of Social Authorities and of all PQE’s employees/collaborators with the Public Administration must proceed with the greatest transparency, correctness and integrity and in strict compliance with the regulations applicable in the countries where PQE operates and with the internal rules, procedures and organizational models that PQE may adopt from time to time.
4.2.4 The Media
Relations with the press and media are exclusively held by the company’s responsible assigned to this function. All the interventions of external communication must be previously authorized by the company’s management.
Adherence to Company Social Media is required to all resources, irrespective of the role.
PQE’s employees must avoid negative comments and judgments towards its competitors. Negative comments about competitors and their services are considered counter-productive and inappropriate.
The only way for promotion / marketing of its products / services is illustrating their value and quality, without demeaning the competitors’ offer.
If a Customer requests a comparison with a competitor’s services, it is permitted to highlight the benefits of PQE’s own services, making sure, however, that any comparison meets the equity and fairness criteria provided by this Code.
PQE recognizes that a fair, free and loyal competition is a decisive factor for the growth and the continuous improvement of the company.
5. Implementing Provisions
5.1 Procedures for disclosure and monitoring the Ethical Code
Information and training on the Code of Ethics and its content is a crucial aspect for the organization and among its objectives, it has the promotion and the strengthening of corporate culture on the recognized values, as well as the disclosure of rules, procedures and practices to be followed and, especially, the extension of the approval to the mission and principles declared.
For this purpose, PQE is committed to establish and implement appropriate internal communications and training / information plans for all employees/collaborators.
The verification and monitoring of the actual compliance with this Code of Ethics is delegated to the internal Supervisory Board, formed by the Operation Manager and the Human Resources Manager, who have been assigned the following responsibilities:
- ensure behaviours in line with the principles of this Code, in order to be the first good example for other employees/collaborators;
- offer full availability to analyze the areas of the implementation and interpretation of the Code;
- commit to select employees and collaborators, internal and external, that give the most reliability to comply with the Code;
- supervise the cases of violation of the Code.
To offer the Code the necessary visibility and awareness, PQE prepares meetings and seminars. The document is also available in an electronic format on the company’s intranet / local network, together with the various procedures and the Organisation, Management and Control Model. In case of new employment contracts or other agreements, they must contain an explicit reference to the current Code of Ethics.
Similarly, communication plans to disclose its contents outside the company will be activated and standardized.
Reference is made, however, to the Organisation, Management and Control Model for the identification of suitable tools and internal control measures.
5.2 Submitting notices of violations to the Ethical Code
Any employee of PQE who is aware (or believes in good faith) that a provision of this Code has been violated or has concerns about any matters addressed in this Code or about its application is encouraged to report the relevant circumstances to his/her manager, or to the Quality Assurance Manager.
Alternatively, a violation of this Code can be reported through the specific reporting channels described in Sections 6.3 and 6.4 of the Organizational Model adopted by Pharma Quality Europe S.r.l. pursuant to Decree 231/2001 (the “Organizational Model”). More specifically, any such report can be addressed to the Monitoring Body (termed Organismo di Vigilanza),
(a) via email to the email address firstname.lastname@example.org; or
(b) via mail to the address: Località Prulli, n 103/C, 50066 Reggello (Florence) – Italy – Att: Organismo di Vigilanza.
All the reports will be managed in a way to ensure to the greatest extent permitted by applicable law the confidentiality or the report and to prevent any act of discrimination and retaliation against the employee that reported a violation in good faith.
Any employee who knowingly submits a report that is false or misleading will be deemed has having violated this Code and will be subject to disciplinary action.
5.2.1 Anonymity and management of reports
PQE does not accept any violation report to the Code in an anonymous way, considering this behaviour unethical and contrary to the principles of the Code.
Once the signed message has been read, the Internal Supervisory Board will carefully analyze it, listening, in separate and reserved locations, to both the reporter and the author of the alleged violation. PQE will act in order to ensure the reporters against any form of reprisal or act, even to the mere suspicion of being a form of discrimination or disadvantage.
In carrying out its activities, PQE has always been identified for the compliance with the current regulations, considering unethical or illegal behaviours as damaging to the relationship of trust with customers, as well as the image of the company, its reputation and credibility.
Any violation to the conduct rules expressed in the Code is therefore subject to disciplinary sanctions proportioned to the gravity of the act performed, to the damage done and the previous acts, including the sanctions specifically set out in Section 8 of the Organizational Model, if applicable.
As mentioned in Section 6.2 also employees who knowingly submit a report regarding the violation of this Code that is false or misleading will be subject to disciplinary action.
These penalties may include, in the most severe cases, even the termination of the employment relationship.
Vision, Mission, Core Values, Customer Needs, Social Responsibility and Integrity are reflected in our Ethical Code.