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
Excerpt from the audit of February 02, 2016
“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.”
Excerpt from the audit of June 19, 2009
“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.”
Excerpt from the audit of June 08, 2014
“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.”
Excerpt from the audit of November 23, 2011
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.”
Excerpt from the audit of August 03, 2006
“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.”
Excerpt from the audit of March 04, 2015
“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.”
Excerpt from the audit of June 13, 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 actually implemented.
The following results of this audit are to be recorded:
- 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.”
- Potential for improvement/ recommendation:
“No significant weaknesses were identified during the audit.”
Excerpt from the audit of March 03, 2006
“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.”
Excerpt from the audit of August 22, 2013
“The audit at GUS Deutschland GmbH Standort Köln was successful.
Overall assessment: GOOD
From the auditor’s standpoint, nothing stands in the way of further cooperation.”
Excerpt from the audit of June 24, 2015
“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.”
August 18-21, 2008
- 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)
- 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 requirements
Excerpt from the audit of November 20, 2007
“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.”
Excerpt from the audit of December 03, 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.
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.”
Excerpt from the audit of December 07, 2005
“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.”
Excerpt from the audit of February 17, 2009
“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.”
Excerpt from the audit of November 28, 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 Deutschland GmbH operates a well-functioning QM system in accordance with 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 OS-ERP software.” […]
“The company was also able to demonstrate that extensive experience in the pharmaceutical industry underpins its competence. The employees have many years of experience in the GxP market, a high understanding of validation requirements and identification with the company.” […]
“Compared with the ERP market (DACH), GUS is very well positioned to meet the requirements of the GxP-regulated industry.”
Excerpt from the audit of December 01, 2011
“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.”
Excerpt from the audit of March 21, 2013
[…] “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 reinforce 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.”
Excerpt from the audit of June 07, 2011
“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.”