Solution Partner Industry Pharmaceutical Process step 05: Partner Re-Certification. Re-Certification Audit Report

Transcription

1 Process step 05: Partner Re-Certification Re-Certification Audit Report Company audited: Cross Integrated Systems Location / date of the audit: 850 Discovery Lane, Knoxville, TN / 09 March 2017 Date of the last audit: 05 Sep Purpose: Confirmation as Audit team: Siemens Klaus Poertner Dr. Alexander Gierse Leader of the audit team: Dr. Alexander Gierse Cross Robbie Peoples, PE Theresa Fitzsimmons Lindsey Clark Jffrey Clark, PhD Date / signature: Page 1 of 5

2 Table of contents 1 Management overview Introduction Purpose of the re-certification Scope of the re-certification List of findings and remarks Summary and conclusion Result Evaluation of the partner... 5 Page 2 of 5

3 1 Management overview Cross Integrated Systems Group (Cross) is a quality driven solutions company providing design, products, and system integration and engineering services to the process industry and municipalities. Further information about the partner can be found on Cross gained the following certificates in the Siemens Solution Partner Program: Solution Partner Automation System SIMATIC Process Control System SIMATIC PCS 7 Solution Partner Specialist Process Control System SIMATIC PCS 7 Solution Partner Industry Pharmaceutical Since September 2006 Cross is a certified. 2 Introduction 2.1 Purpose of the re-certification Within the program, a re-audit takes place periodically to assure the required partner quality. This audit is an essential component to confirm the certification. Besides the current availability of qualified personnel for GxP related project, passing this re-audit is an indispensable prerequisite to renew the certificate. 2.2 Scope of the re-certification During the audit, the organisation and the quality management system of services in the GxP regulated industry are investigated, based on the audit questionnaire. Page 3 of 5

4 3 List of findings and remarks The general approach during the re-audit was: Verifying, in which kind the partner has modified his organisation, employees, quality management system and project execution for the pharmaceutical industry. The findings of this audit are documented in the table below. They are classified in three categories reflecting their impact on the program. Major finding means a finding which must be corrected before the (re-)certification can be confirmed. Minor finding means a finding which should be corrected within an agreed timeframe (not mandatory before the (re-)certification is confirmed). Their effective correction will be checked during the next re-certification. Recommendation is not a finding and should provide as a suggestion of improvement for further development of processes and quality of the partner. The table below lists the detected findings and suggestions for possible corrective measures. These suggested measures are not meant to be prescriptive. No. Description Classification Suggested measures 2.5 Project quality Lessons Learned: Lessons learned are being conducted at the end of projects and documented in the project overview form P12. A formal procedure to distribute the best practice results companywide is missing. Recommendation Establish a formal procedure to ensure the exchange of experience for each Project Manager based on the Lessons learned of the projects. Page 4 of 5

5 4 Summary and conclusion 4.1 Result The partner has established a solid and mature quality management system (QMS), which has been complemented by specific procedural rules and document templates for projects in GxP regulated industry. The approach is based on the recommendations of the GAMP guide for implementation of computer systems in the GxP regulated industry. The partner possesses also profound knowledge in development of automation solutions based on SIMATIC products. He is a qualified Solution Partner since many years. Based on the listed findings and recommendations in chapter 3 and in consideration of company specific aspects, the partner should keep on improving its quality system continuously. Within the scope of the re-audit there are detected: No major findings No minor findings One recommendations This leads the auditors to the following evaluation. 4.2 Evaluation of the partner Cross is evaluated in the context of the program as being: Not suitable (see also chapter 3 List of findings and remarks ) Suitable under proviso (see also chapter 3 List of findings and remarks ) Suitable to supply application software, technical documentation and validation documentation including project development Page 5 of 5