Quality from the customer's point of view
Our supplier audits
Supplier audits
In supplier audits, customers and interested parties review our quality management system. More and more companies, especially from the pharmaceutical industry, are following the recommendations of the GAMP guidelines, which expressly recommend that pharmaceutical companies conduct supplier audits.
As we are constantly working on optimizing our processes, information from external audits is particularly valuable as it is not subject to our natural "operational blindness". We have received numerous suggestions for process and quality optimization from supplier audits and have been able to implement them successfully.
The quality standards of our customers are the benchmark for our actions.
Results from supplier audits
Extract from the audit from 02.02.2016
"GUS presented itself as a very structured company during the audit. Based on many years of experience in the GMP area through previous projects and the present inspection results, GUS fully complies with the requirement of Annex 11, Computerized System, of the EU GMP Guide as well as the requirements of the Aide-Memoire "Monitoring of Computerized Systems" of the ZLG and can thus be classified as a qualified supplier of ERP software."
Extract from the audit of 19.06.2009
"The strengths of GUS certainly lie in its consistent focus on quality for many years. 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 communicated sustainably by the employees and the management during the entire audit. The focus on quality was demonstrated by the current QM system and the tool-supported documentation of the system and development tests (through e.g. VALREP). The audit confirmed that GUS develops software and provides services in accordance with GxP requirements."
Extract from the audit of 08.06.2014
"The supplier audit carried out at GUS ERP GmbH, Cologne site, has shown that the audited areas are
- Quality management system
- Software development process
- Test procedure
- Support and maintenance
- FDA 21 CFR Part 11 Compliance
complies with the principles and requirements set out in the ISPE GAMP5 guidelines.
The supplier audit also confirms that GUS ERP 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 point of view, nothing stands in the way of further cooperation."
Extract from the audit of 23.11.2011
"The audit could be carried out in an open and friendly atmosphere. The requested information was available at short notice and the staff was competently available for questions. The QM system of GUS made a well thought-out and transparent impression. The special requirements of the pharmaceutical environment were obviously known and were met accordingly."
Extract from the audit of 03.08.2006
"GUS ERP GmbH was able to prove that the GUS-OS ERP system was developed using a mature quality management system.
The quality management system covers the GMP requirements for the development of software.
A significant factor for the quality is the distinctively high level of qualification and experience of the employees, the untypically long industry experience and the references in the pharmaceutical industry."
Extract from the audit from 04.03.2015
"GUS Group has extensive project and audit experience in the GxP regulated market.
Formally, the audit confirmed that the requirements for software development in implementation projects are met in accordance with Good Practice and the requirements of ISPE GAMP5.
In addition, the project staff has good knowledge of GMP
The QM system is well documented proved capable of mapping the process of software development and especially ensuring traceability.
However, the formal correctness of the working method does not necessarily allow a conclusion to be drawn about successful project execution overall."
Extract from the audit of 13.06.2007
"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 really lived."
The following findings from this audit should be noted:
- Strength of the company:
"The strengths of GUS certainly lie in the consistent focus on quality for many years. The quality awareness and associated QM system has grown and been internalized. Here, the benefits of quality have been recognized and implemented. This has been communicated throughout the audit to the current QM system, the tools used by the company (e.g. VALREP) as well as to the employees and the management. The audit confirmed that GUS develops GMP compliant software and provides services. - Potential for Improvement/Recommendations
"No significant weaknesses were identified during the audit."
Extract from the audit of 22.08.2013
"The audit at GUS ERP GmbH, Cologne site was successful.
Overall rating: GOOD
From the auditors' point of view, nothing stands in the way of further cooperation."
Excerpt from the audit dated 19.07.2019
"GUS services Pharmpur GmbH in the preparation of an ERP system for Pharmpur's business processes. The company is very well suited for this purpose. GUS demonstrated to have a very good quality management system in place. The system is based on ISO9001:2015. Pharmaceutical processes are known to GUS."
Excerpt from the audit dated 03.09.2019
- GUS Deutschland GmbH maintains a very well-functioning quality management system certified to ISO 9001:2015.
- The audit results confirm the very high level of expertise of the employees in the context of software development and validation in the GxP-regulated environment.
- During the project phase for the introduction of the GUS-OS ERP software, GUS Deutschland GmbH was able to impress with its many years of experience in software implementation in the pharmaceutical industry.
Excerpt from the audit dated 21.11.2019
"The approval of the GUS Group as a qualified supplier and serviceleister is recommended."
Extract from the audit dated 11.11.2021
"The audit revealed that GUS ERP GmbH operates a well-functioning quality management system and has extensive experience with the requirements for software implementation in a GMP-regulated environment. The processes are comprehensively documented."
Extract from the audit dated 19.04.2023
Conclusion: The supplier GUS ERP GmbH remains an approved supplier of BGS.
Extract from the audit of 24.06.2015
"In the conducted audit for the requalifization of GUS, the company presented itself with a strong focus on the quality management system." [...].
"Overall, a very positive general impression has emerged. GUS has expanded and further optimized its quality processes.All audit participants promptly provided the requested information as well as explained it in detail. The requested documentation was available in full.
The GXP conformity is still given. The FDA compliance highlighted in the last audit was highlighted in key points and could be confirmed at these points."
18.08. - 21.08.2008
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
- 21 CFR Part 11 Assessment (Electronic Records/Signature) for GUS OS ERP
- GMP suitability of GUS OS ERP software functional requirement
Extract from the audit of 20.11.2007
"The GUS group is trusted providing 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 base, 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 documentedprocedures were impressively presented. The ISO certification provides evidence that this is agreed by certifiers."
Extract from the audit from 03.12.2014
"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.
The company GUS Group was able to show in the audit 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 underpins its competence. It could be shown that first projects at pharmaceutical companies with medical devices were successfully realized.
The employees have a long experience in the GxP market, a high understanding of the validation requirements and identification with the company.
The company GUS is very well positioned to the requirements of the GxP regulated industry compared to the ERP - market (DACH)."
Extract from the audit of 07.12.2005
"GUS has installed a QM system that is suitable to ensure the creation of software for the pharmaceutical sector that meets the requirements of GMP."
"Particular emphasis should be placed on the great efforts made by the GUS Group to meet the requirements of the pharmaceutical industry for documentation and validability of such a program in the GUS-OS ERP. Likewise, the wide range of assistance that can now be offered to these companies in the validation process."
"The GUS Group can be approved as a software supplier for the pharmaceutical sector."
Extract from the audit of 17.02.2009
"The quality management system of GUS ERP 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 the transparency and sovereignty that existed during the audit on the part of GUS.
No corrective measures required."
Extract from the audit report dated 28.11.2016
"The audit was conducted in a positive atmosphere and was characterized by a high understanding of quality." (...)
"The audit was very well prepared." (...)
"GUS ERP GmbH operates a well-functioning QM system according to ISO 9001:2008, which was randomly audited. 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 underpins its competence. The staff has a long experience in the GxP market, a high understanding of the validation requirements and identification with the company." (...)
"Compared to the ERP market (DACH), the GUS company is very well positioned to meet the requirements of the GxP-regulated industry."
Extract from the audit of 01.12.2011
"The implementation of assured 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 presented quality assurance system is lived and implemented in all relevant areas of the company." [...]
"With regard to the use of standard solutions in the pharmaceutical GxP area as well as the associated services, GUS is classified as a Qualified Supplier."
Extract from the audit from 21.03.2013
[...]"The 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 able to demonstrate in the audit 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 underpins its competence." [...]
"The staff has a long experience in the GxP market, a high understanding of the validation requirements and identification with the company.
The company GUS is very well positioned to the requirements of the GxP regulated industry compared to the ERP market (DACH)."
Extract from the audit of 07.06.2011
"The audit team received confirmation that GUS has anextensive 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."