QM Handbook - GUS Deutschland

You have opened the start page of our quality management handbook. Our handbook consists of a public and a non-public area. You may explore the public area as you wish. Links to the non-public area are marked as “non-public.” This is confidential, additional information about our company and its processes, access to which is restricted to our employees.

 

I hope you enjoy reading this handbook.

Note: This English version of the QM handbook is an information copy. The translation serves English-speaking customers as a source of information about our QM system. This is not a controlled document and has no binding effect on the QM system of the GUS.

(Version 1.9 as of January 9, 2019)

Scope

The scope of our quality management system extends to all processes and organizational units of

  • GUS Deutschland GmbH
    Bonner Straße 172-176
    50968 Köln
  • GUS Deutschland GmbH – Niederlassung Hamburg
    Heidenkampsweg 73
    20097 Hamburg
  • GUS Deutschland GmbH – Niederlassung München
    Rosenheimer Str. 143
    81671 München
  • GUS Schweiz AG
    Sonnenstraße 5
    9000 St. Gallen
    Schweiz

Conformity

Our quality management system meets the requirements of the DIN EN ISO 9001:2015 standard.
DQS Certificate for download

Inapplicability

Since we do not use test equipment that needs to be calibrated, the requirements of item 7.1.5 of the DIN EN ISO 9001:2015 standard (resources for monitoring and measurement) are not relevant to our company and are not applicable.

(Version 1.4 as of January 16, 2018)

Probably no other industrial sector sets such high-quality standards as companies from the pharmaceutical, food and beverage, chemical, cosmetics, and biotechnology sectors as well as the related logistics. The products of these companies touch the direct sphere of human life and therefore people’s health, well-being and quality of life.

Therefore, the requirements for the development, procurement, production, quality control and distribution as well as for the accompanying information go far beyond the standards of an industry standard such as ISO 9001:2015. In addition to the guidelines of Good Manufacturing Practice (GMP) and related regulations such as Good Laboratory Practice (GLP) and Good Storage Practice (GSP) in the pharmaceutical sector, there are countless legal or official requirements: Be it the provisions of the Medicinal Products Act (AMG), the Ordinance on the Manufacture of Medicinal Products and Active Ingredients (AMWHV), chapter 21 of the Codes of Federal Regulations (CFR), or – for the food sector – the Food Hygiene Law and the EU Regulation 178/2002.

In addition, retail guidelines such as International Food Standard (IFS) and British Retail Consortium (BRC) Global Standard Food must be complied with. These frameworks all focus on the diligence of the company and its employees.

Validation is also an important instrument of quality assurance that is recognized by the industry. In this respect, the GUS Group complies with the provisions of the Pharmaceutical Process Engineering Association (APV), which are laid down in the APV guideline “Computerized systems.”

Our diligence also includes the selection of production equipment and software systems.  We take it as a compliment to our own quality orientation that numerous companies in the life sciences industries have chosen our solutions to support their quality-oriented business processes. We made the qualify specifications of our customers the benchmark for the quality objectives of our own business processes. This diligence is expressed in our charter and is therefore an obligation for every single employee – and this in all areas of responsibility:

  • In the development and testing of software systems
  • In the implementation of customized specifications
  • In the support and system support in sales
  • In the selection of system components
  • In the qualification of employees
  • In the company organization

Qualitaetscharta 1 - GUS-OS Suite - GUS DeutschlandCommitment, personal responsibility and professional competence of the individual are the supporting pillars of our success. The requirements and wishes of our customers determine our objectives. The organization of our company with its structures, goals and regulations creates the suitable setting for a high-performance community. In this community, everyone is responsible for the results of the work assigned to them within the scope of their own competence and responsibilities.

Quality Objectives
We have defined and established process indicators (non-public) for the control, analysis and improvement of our quality objectives.

These indicators are regularly collected and analyzed. The process key figures are determined in different rhythms depending on the key figure and are the basis for the monthly management meeting. In this meeting, the figures are analyzed and, if necessary, controlling measures are taken.

(Version 1.3 as of January 16, 2018)

All our core processes in the areas of

  • development
  • sales
  • new customer projects
  • existing customer care

focus on our customers. In the following graphic you will find information about our processes:

QM Grafik 1 - GUS-OS Suite - GUS Deutschland

(Version 1.4 as of February 13, 2012)

Structure of the QM Specification Documentation

The specification documentation of our management system consists, in addition to this management handbook, of process descriptions, guidelines, work instructions and checklists (non-public), which describe process sequences and contain specifications for their proper implementation. Furthermore, these documents refer to other applicable forms, checklists and guidelines (non-public). All QM specification documents can be identified clearly by their revision level.

Updating, Checking and Releasing the QM Specification Documentation

The respective process owners are responsible for updating the QM specification documentation. The following applies to the signature rules for QM specification documents:

⇒ Creation ⇒ Author
⇒ Inspection ⇒ Process owner, process participation, QM representative
⇒ Release ⇒ Spokesman of the managing directors

The control of the QM specification documents (non-public) is carried out by the QM organizational area, which ensures that the current valid version of the specification documentation is available and known to all employees in the company. Each QM specification document always remains valid until a new version is officially released or the document is withdrawn. The intended optimization and/or modification of a process is also subject to the specifications of approved QM specification documents, i.e. the application of existing rules. However, in consultation with the QM representative, a process owner can define a pilot project and/or an exception that is not subject to the existing rules. However, this is, without exception, bound to the written approval of the QM representative. Should it not be possible to apply existing rules in an individual case (e.g. because a situation is not taken into account in the specification), without being able to coordinate this with the QM representative (e.g. because of a necessary short-term decision ), this must be documented in writing by the process owner, stating the initial situation and the considerations that have led or will lead to the deviation, and sent to the QM representative.

Release of QM Specification Documents

The QM handbook is public and may be passed on as a copy to customers and other interested parties. However, these are exclusively informative copies which are not subject to the ongoing modification and exchange service. They only correspond to their current status when they are published. Other documents, such as process descriptions and work instructions (non-public), contain know-how of our company and must therefore be treated confidentially. The release of these documents to entities outside our company requires the approval of the company management in each individual case.

Data and Records

The type and scope of necessary records are specified in our QM specification documentation. Test results are recorded for the respective processes and products. Such records serve as proof of the test carried out and to document the results. These records are regularly evaluated by the process owners in order to obtain information on changes and weaknesses in the organization.

(Version 1.3 as of January 16, 2018)

Planning and Control

At the beginning of the financial year, the parameters critical to the success of the company’s key figures of recent years are analyzed. Based on this, a plan for the coming financial year is drawn up together with the expected market development. This plan is broken down to the individual months together with the planning parameters. These planning figures and planning parameters form the basis for the monthly target-actual-analysis. Within the scope of this analysis, all economic and performance-influencing parameters are processed and subjected to a comprehensive analysis. This puts GUS in a position to react to changes in the market and quickly take the necessary measures for business management.

Process Key Figures

We have defined and established process indicators (non-public) for the control, analysis and improvement of our quality objectives, which are regularly collected and analyzed. The process key figures are determined in different rhythms depending on the key figure and are the basis for the monthly management meeting. In this meeting, the figures are analyzed and, if necessary, controlling measures are taken. In regular management reviews, commercial and quality-related data of the company are analyzed and discussed, which allow conclusions to be drawn about the performance of the company’s processes. Inputs for the management review are:

  • Results of internal audits,
  • Results of supplier audits,
  • Feedback from customers (reports to the hotline),
  • Process key figures,
  • Economic key figures
  • Target-actual-comparisons with the planning data
  • Status of preventive and corrective measures,
  • Changes that affect the management system,
  • Recommendation for improvements
  • Feedback from relevant interested parties
  • Results of monitoring and measurements
  • Services from external providers

In the event of anomalies, suitable measures are initiated in order to react as quickly as possible to the weaknesses identified in the company. The results and specifications of the assessment are recorded and communicated to the responsible persons. The implementation of agreed measures is monitored by the quality representative and the management circle.

Internal Audits

In internal audits (non-public), we regularly check the implementation of our specifications in practice and the knowledge of the employees about the regulations affecting their work.  Particular attention is paid to the development of process optimizations; on this topic, our employees can provide valuable information from their practical work. Audits are systematically planned and carried out by trained, competent personnel. The results of internal audits are documented. Deviations from the specifications and identified weak points are backed up with appropriate measures to eliminate the causes. The effectiveness of such corrective and preventive measures is checked in follow-up audits.

(Version 1.3 as of January 16, 2018)

Our management system is reviewed by several independent control procedures and supervisory bodies.

Supplier Audits

In supplier audits, customers and interested parties review our quality management system.

More and more companies, especially from the pharmaceutical industry, follow the recommendations of the GAMP guide, which strongly recommends that pharmaceutical companies conduct supplier audits. As we are constantly working on the optimization of our processes, external audit information is particularly valuable, as it is not subject to our natural “operational blindness.” From supplier audits, we have received numerous suggestions for process and quality optimization and have been able to implement them successfully.

Results of Supplier Audits (Excerpts)

September 27, 2016 Schaper & Brümmer
Due to the positive audit results, the auditors recommend that GUS Deutschland GmbH be approved as a qualified supplier for the development, implementation and maintenance of the ERP system GUS-OS Suite. […]
GUS Deutschland GmbH operates a well-functioning QM system in accordance with ISO 9001:2008, which was randomly tested. […]
The audit results prove the necessary experience and GMP competence of the company for the development, implementation and maintenance of the OS-ERP software. […]
The company was also able to demonstrate that extensive experience in the pharmaceutical industry reinforces its competence.

February 02, 2016 aniMedica
Summary/ Assessment
During the audit, GUS presented itself as a very structured company. Based on many years of experience in the GMP area through previous projects and the inspection results available, GUS fully complies with the requirements of Annex 11 “Computerized systems” of the EU GMP guideline and the requirements of the memory aid “Monitoring of computerized systems” of the ZLG and can therefore be classified as a qualified supplier of ERP software.

June 24, 2015 medac GmbH
In the conducted audit for the requalification of GUS, the company presented itself with a strong focus on the quality management system. […] We had a very positive overall impression. GUS has expanded and further optimized its quality processes.
All audit participants immediately provided the requested information and explained it in detail. The requested documentation was completely available.
The GXP conformity is still given. The FDA compliance highlighted in the last audit was examined in detail and could be confirmed at these points. […]

March 04, 2015 Excella GmbH & Co. KG
The GUS Group AG & Co. KG has extensive project and audit experience in the GxP-regulated market.
The audit has formally confirmed that the requirements for software development within the framework of implementation projects in accordance with good practice and the requirements of ISPE GAMP5 are fulfilled.
In addition, the project staff have good knowledge of GMP.
The QM system is well documented and proved to be able to map the process of software development and particularly to guarantee traceability.
However, the formal correctness of the working method does not necessarily allow conclusions to be drawn about the overall success of the project.

December 03, 2014 Protina
The audit was conducted in a positive atmosphere.
The audit was very well prepared. The introduction to the audit was well structured.
The results prove the necessary experience and GMP competence of the company for the development, implementation and maintenance of the OS-ERP software.
During the audit, the GUS Group was able to demonstrate that customers from the GMP-regulated industry have carried out successful audits in recent years. The company was able to demonstrate that extensive experience in the pharmaceutical industry reinforce its competence. It could be shown that first projects with pharmaceutical companies with medical devices have been successfully realized.
The employees have many years of experience in the GxP market, a high understanding of the validation requirements and identification with the company.
Compared to the ERP market (DACH), GUS is very well positioned to meet the requirements of the GxP-regulated industry.

June 08, 2014 BAG
The supplier audit carried out at GUS Deutschland GmbH (Cologne site) showed that the audited areas

  • Quality management system
  • Software development process
  • Test procedures
  • Support and maintenance
  • FDA 21 CFR Part 11 Compliance

comply with the principles and requirements set out in the ISPE GAMP5 Guide.
The supplier audit also confirms that GUS Deutschland GmbH has the necessary experience in the GxP environment, and that the development, implementation and maintenance of the GUS OS Suite software is carried out in accordance with applicable regulatory requirements.
From the auditor’s standpoint, nothing stands in the way of further cooperation.

August 22, 2013 Lichtenheldt GmbH
The audit at GUS Deutschland GmbH (Cologne site) was successful.
Overall assessment: GOOD
From the auditor’s standpoint, nothing stands in the way of further cooperation.

March 21, 2013 Stoma
[…] The results prove the necessary experience and GMP competence of the company for the development, implementation and maintenance of the OS-ERP software. In the audit, the company was able to demonstrate that customers from the GxP-regulated industry have carried out successful audits in recent years. The company was able to demonstrate that extensive experience in the pharmaceutical industry reinforces its competence. […]
The employees have many years of experience in the GxP market, a high understanding of the validation requirements and identification with the company. Compared to the ERP market (DACH), GUS is very well positioned to meet the requirements of the GxP-regulated industry.

July 31, 2012 BGS
Conclusion: The very good impression gained during the offer and project phase was confirmed in the audit. Strength: GUS maintains and lives an appropriate and well-documented quality management system, where effort and benefit seem to be in a very good relation. No deviations were found. GUS should be approved as a supplier for the quality-relevant product ERP system GUS-OS.

> Audit report (non-public)

December 01, 2011 Steigerwald
The implementation of secured processes – initiated by the certification – especially in the areas of product development and project execution shows that the company pursues an active quality policy and does not merely react to customer requirements. […]
The auditors gained the impression that the quality assurance system presented is pursued and implemented in all areas of the company. […]
Regarding the use of standard solutions in the pharmaceutical GxP area and the associated services, GUS is classified as a qualified supplier.

> Audit report (non-public)

November 3, 2011 bela-pharm GmbH & Co. KG
The audit was conducted in an open and friendly atmosphere. The requested information was made available at short notice and the staff was competently available for questions. The QM system of GUS gave the impression of being well thought-out and transparent. The specific requirements of the pharmaceutical environment were obviously known and have been fulfilled accordingly.

> Audit report (non-public)

June 07, 2011 Tillotts Pharma AG
The audit team received confirmation that GUS has an extensive and well-applied Quality System in place. Development methods and testing standards are defined and applied. Product release follows predefined methods. Change control and configuration management are handled skillfully. Document review and approval is clearly established for QMS documentation.

> Audit report (non-public)

June 19, 2009 AvidiaMed
The strengths of GUS certainly lie in their many years of consistent focus on quality. The quality-awareness and the associated QM system have been continuously developed and internalized. The fact that the benefits of quality have been recognized and implemented could be conveyed throughout the entire audit by the employees and management. The focus on quality was demonstrated by the current QM system and the tool-supported documentation of the system and development tests (e.g. by VALREP). The audit has confirmed that GUS develops software and provides services in accordance with GxP requirements.

> Audit report (non-public)

February 17, 2009 SANIPharma GmbH
The quality management system of GUS Deutschland GmbH is exemplary and managed at a high level. This can be seen, among other things, in the regular certifications according to DIN EN ISO 9001, as well as in the transparency and sovereignty that GUS showed during the audit. No corrective measures required.

Audit report (non-public)

August 18-21, 2008 medac Gesellschaft für klinische Spezialpräparate GmbH
Results
Overall assessment:

  • GUS Development Lifecycle processes and procedures are VERY GOOD
  • GUS staff are all competent, good listeners, open to change, know their business
  • GUS team appears to be committed to the overall success of the joint Medac/GUS Project
  • Auditors feel that GUS has the ability to compete in the US market (and worldwide)

Pluses

  • Training Documentation availability on the intranet
  • Configurability of the system
  • Audit trail functionality
  • Cross functionality
  • Visualization of BOM level to review status, deviations, etc.
  • Quality Systems
  • Ability to generate the documentation of roles, workflows, etc. needed for IQ
  • Real-time database for capturing errors and problems

Assessment documents were generated in the following areas:

  • Review of Quality Systems, Development and Production Life Cycle Supporting GUS-OS ERP


November 20, 2007 Parexel
The GUS group is trusted to provide software with high quality. The company is also trusted to deliver appropriate services to its customers, and to continue to do so in future. This is proven by the company’s history, the large customer basis, the high number of installations, and the loyalty of customers.

The staff is trusted to be competent, knowledgeable, and well trained as proven by (most) personal files. The Quality Management system including the QM handbook and all documented procedures were impressively presented. The ISO certification provides evidence that this is agreed by certifiers.

Audit report (non-public)

June 13, 2007 Henning Arzneimittel GmbH
“During the audit, the company management, all directly and indirectly involved employees from development, project and service conveyed absolute knowledge and application of the QM system and that this is actually implemented.
The following results of this audit are to be recorded:

  1. Strength of the company:
    The strengths of GUS certainly lie in their many years of consistent focus on quality. The quality awareness and the associated QM system have developed and been internalized. The benefits of quality have been recognized and implemented here. This has been conveyed by the current QM system, the tools used by the company itself (e.g. VALREP), by the employees and management during the entire audit. The audit has confirmed that GUS develops software and provides services in accordance with GxP requirements.
  2. Potential for improvement/ recommendation:
    No significant weaknesses were identified during the audit.”

Audit report (non-public)

August 03, 2006 Bombastus-Werke AG
“GUS Deutschland GmbH was able to prove that the GUS-OS ERP system was developed using a well-developed quality management system.
The quality management system covers the GMP requirements for software development.
Significant factors for the quality are the distinctly high level of qualification and experience of the employees, the untypically long industry experience and the references in the pharmaceutical industry.”

Audit report (non-public)

March 03, 2006 Interested Party
“The quality management system presented within the framework of this audit is suitable for ensuring transparent software development, for documenting and processing errors and their correction in a traceable and controlled manner, and for enabling an appropriate, largely prepared implementation of the GUS-OS ERP software at the customer.”
“What is particularly noteworthy about GUS-OS ERP is that the customer’s validation activities are supported by extensive test documentation already created during development, as well as a validated documentation tool VAL-REP for recording the test cases.”
“No critical and serious or other types of deficiencies have been found in the audit.”

Audit report (non-public)

December 07, 2005 Riemser Arzneimittel AG
“GUS has installed a QM system which is capable of ensuring the creation of software for the pharmaceutical sector, which complies with the requirements of the GMP.”
“The great efforts which the GUS Group has undertaken with GUS-OS ERP in order to fulfill the requirements of the pharmaceutical industry regarding the documentation and validity of such a program shall be especially highlighted. The same applies to the many and varied aids that can now be offered to these companies for validation.”
“The GUS Group can be approved as software supplier for the pharmaceutical sector.”

> Audit report (non-public)

Annual Review of System Improvement
Once a year, the German Association for the Certification of Management Systems (DQS) reviews our quality management system in an “assessment for system improvement.” In this assessment, the quality management system, document control (non-public), the implementation of the specifications in practice, and the knowledge of the employees about process descriptions (non-public), specifications, and guidelines are checked. From these assessments, we have also successfully implemented numerous suggestions for process and quality optimization.

Expert Reports
To verify development work and process management tasks, we commission external experts at irregular intervals to prepare expert reports. Particularly with the new introduction of the GUS-OS solution family, the development processes and customer projects were subjected to a detailed external review.

(Version 1.3 as of January 16, 2018)

Assessment of the Management System

The basis for the evaluation of the key figures and information of our company are the goals of our company or the comparison with figures from previous reporting and evaluation periods as well as the planning data. In the event of error accumulations, tendentious deterioration of results and within the scope of our activities for continuous improvement, measures are initiated to eliminate the causes of errors or deteriorations. The assessment of the management system takes place at several levels: assessment by the management circle (management reviews). In regular management reviews, commercial and quality-relevant data of the company are analyzed and discussed, which allow conclusions to be drawn about the performance of the company’s processes. Inputs for the management review are:
  • Results of internal audits,
  • Results of supplier audits,
  • Feedback from customers (reports to the hotline),
  • Process key figures,
  • Economic key figures
  • Target-actual-comparisons with the planning data
  • Status of preventive and corrective measures,
  • Changes that affect the management system,
  • Recommendation for improvements
  • Feedback from relevant interested parties
  • Results of monitoring and measurements
  • Services from external providers

In the event of anomalies, suitable measures are initiated in order to react as quickly as possible to the weaknesses identified in the company. The results and specifications of the assessment are recorded and communicated to the responsible persons. The implementation of agreed measures is monitored by the quality representative and the management circle.

 

Management Review

We carry out a formal assessment of our management system once a year.

The basis for this is the report of the quality management representative. Inputs for this report are:

The report also contains information about

  • Status of corrective and preventive measures,
  • Changes that affect the management system,
  • Recommendations for improvements.

The results and definitions of the evaluations are recorded and communicated to the persons responsible. The implementation of agreed measures is monitored by the quality management representative and management circle.

Corrective and Preventive Measures

The control and monitoring of corrective and preventive measures (non-public) is carried out by the QM organization area.

 

Corrective Measures
By regularly observing and evaluating the data obtained in audits, deficiencies in the organization can be identified at an early stage. Those responsible for the subject areas must identify systematic deficiencies within the scope of their responsibility and competence and remedy them immediately or report them to their superiors. Error bursts are identified, and the causes are eliminated by appropriate measures. Small corrective measures are implemented directly and unbureaucratically by those responsible. Extensive corrective measures, where, for example, the repeated occurrence of critical errors is to be counteracted, cross-departmental or cross-company measures are necessary, or far-reaching investment or organizational decisions are expected, are coordinated with the management level. Depending on the scope of the measures, they are systematically planned, documented and implemented. Corrective measures that affect existing regulations in our company are entered accordingly in the documentation of our management system. The effectiveness of corrective measures is reviewed.

 

Preventive Measures
Preventive measures are initiated to minimize or eliminate expected risks in products or processes regarding their quality-relevant effects before problems arise. They are based on the experience gained from known, comparable processes and procedures, and are incorporated into the planning and development of new products and the improvement of existing processes and procedures. The effectiveness of preventive measures is reviewed.

(Version 1.2 as of January 25, 2013)

The quality management representative is equipped with the authority to decide on all quality-relevant actions concerning our quality management system. He/she has the task of maintaining and further developing our QM system, which is certified according to the DIN EN ISO9001 standard. Furthermore, he/she is responsible for the control of an efficient implementation of the quality-relevant instructions. He/she is also responsible for training employees to sensitize them to the concerns of quality management. In his/her area of responsibility, the quality representative acts free of instructions and independent of superiors. Tasks:

  • Development, maintenance and further development of the management system in accordance with DIN EN ISO9001
  • Review of QM specification documents (creation by the process owners)
  • Updating and monitoring of corrective and preventive measures (elaboration by the process owners)
  • Implementation of supplier audits
  • Implementation of internal audits
  • Training of employees on the QM system
  • QM representative certificate of appointment (non-public)

(Version 1.2 vom 13.02.2012)

(Version 1.2 as of February 13, 2012)

The management of GUS Deutschland GmbH puts this handbook into effect as of today and stipulates that the instructions contained therein as well as related documents are binding for the employees of the company.

Cologne, 13.02 2012

M Bingler - GUS-OS Suite - GUS Deutschland

Dirk Bingler | Spokesman of the Managing Director