Quality from Customer’s point of view

Supplier Audits

In supplier audits, customers and interested parties review our quality management system. Ever more companies, especially from the pharmaceutical industry, follow the recommendations of the GAMP-Guidebook, which expressly recommends the performance of supplier audits by pharmaceutical companies.

Since we are constantly working on the optimization of our processes, indications from external reviews are especially valuable, seeing as they are not subject to our natural “subjective blindness”. We have received and been able to implement many suggestions towards process- and quality optimization from supplier audits.

Your contact person

Marcus Nohl

QM-Beauftragter

Results from supplier audits

AvidiaMed GmbH

Extract of Audit from 06/19/2009

The strength of GUS surely lies in their many years of consistent focus on quality. The quality-awareness and the thereto connected QM-System have continued to develop and become internalized. That the benefits of quality are recognized and implemented could continually be observed in the employees and the management during the entire audit. The focus on quality is seen in the actual QM-System and in the Tool-supported documentation of the system- and development-tests (by for example VALREP). The audit has confirmed that GUS develops Software and provides services in accordance with the GxP-Requirements.

bela-pharm GmbH & Co KG – Arzneimittelfabrik

Extract of Audit from 11/23/2011

The audit could be performed in an open and friendly atmosphere. The requested information was made available at short notice and the personnel were 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 well-known and have been fulfilled accordingly.

Bombastus-Werke AG

Auszug aus dem Audit vom 03.08.2006

„Die GUS Deutschland GmbH konnte belegen, dass das GUS-OS ERP-System unter der Anwendung eines ausgereiften Qualitätsmanagementsystems entwickelt wurde.
Das Qualitätsmanagementsystem deckt die GMP-Anforderungen an die Entwicklung von Software ab.
Ein signifikanter Faktor für die Qualität sind der ausgeprägt hohe Grad der Qualifizierung und Erfahrung der Mitarbeiter, die untypisch lange Branchenerfahrung und die Referenzen in der Pharmazeutischen Industrie.”

Henning Arzneimittel GmbH

Extract of Audit from 06/13/2007

“During the audit the company management and all direct and indirectly involved employees, from Development, Project and Service conveyed absolute knowledge and application of the QM System and that this is also truly lived as such.
The following results from this audit are to be noted:

Strengths of the company:

  1. The strength of GUS surely lies in their many years of consistent focus on quality. The quality-awareness and the thereto connected QM-System have developed and become internalized. Here the benefits of quality are known and implemented. This was consistently conveyed by the actual QM System, the self-utilized tools (e.g. VALREP) as well as by the employees and the management during the entire audit. The audit has confirmed that GUS develops Software and provides services in compliance with GMP.
  2. Improvement potential/Recommendations
  3. No major weaknesses were identified during the audit.
medac Gesellschaft für klinische Spezialpräparate mbh

Extract of Audit from 24/06/2015

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
  • 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
Parexel

Extract of Audit from 20/11/2007

The GUS group is trusted providing software with high quality. The company is also trustedto deliver appropriate services to its customers, and to continue to do so in future. This isproven 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 documentedprocedures were impressively presented. The ISO certification provides evidence that this is agreed by certifiers.

Prospect

Extract of Audit from 03/03/2006

“The Quality Management system introduced with regards to this audit is appropriate in order to guarantee a comprehensible Software Development, to comprehensibly document errors and their correction and then implement the corrections in a controlled fashion, and to enable a proper, extensively prepared implementation of the Software for the customer.
“In particular, it is to be highlighted that with GUS-OS ERP the validation activities of the customer are supported by an extensive test-documentation, already provided in the framework of development, as well as a validated documentation tool VAL-REP for the recording of test cases.”
“There were no critical, serious or other defects determined during the audit.”

Riemser Arzneimittel GmbH

Extract of Audit from 12/07/2005

“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 have undertaken with GUS-OS ERP in order to fulfill the requirements of the pharmaceutical industry with regards to documentation and validity of such a program are to be especially highlighted. Likewise, the multiple aids which these firms can now be offered when it comes to validation.”
“The GUS Group can be approved as Software supplier for the pharmaceutical sector.”

SANIPharma GmbH

Extract of Audit from 17/02/2009

The Quality Management system of GUS German GmbH is exemplary and operated on a high level. This is reflected inter alia, by the regular certifications according to DIN EN ISO 9001, as well as in the transparency and confidence which was shown on the side of GUS during the audit.

No corrective measures necessary.

Schaper & Brümmer GmbH & Co.KG

Extract of Audit from 28/11/2016

The audit was conducted in a favourable atmosphere, characterised by a consistent and comprehensive concept of quality. (…) The audit itself was prepared cautiously with special regards to precision and efficiency. (…) GUS Deutschland GmbH employs a reliable and approved QMS according to ISO 9001:2008, which is applied in regular random checks. The audit outcome is evidence of profound experience and GMP-competency when it comes to development, implementation and maintenance of ERP-software. (…) Furthermore, the results substantiate GUS’ reputation as an ERP-expert on the pharmaceutical market; the key to success, however, are well trained staff who can rely on perennial GxP-expertise, in depth understanding of validation requirements and processes, as well as a fundamental sense of identification with the company. (…) Compared to the ERP-market average, GUS proves to consistently exceed the GxP driven expectations of the industry.

Tillotts Pharma AG

Auszug aus dem Audit vom 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.

Simple Share Buttons
Simple Share Buttons