Dr. Solomon, has a title Doctor of  Pharmacy and has achieved
know-how of more than 15 years of theory and practice on
qualification and validation  in pharmaceutical and medical device manufacturer, Vaccine manufacturing, Software validation  (according to GxP, GAMP, Annex 11 and 21 CFR Part 11).

Recent Project is as part of Business Analyst creating UAT for global and local methods using HP ALM and ELN Empower based software  

As a CSV specialist worked for  Janssen Vaccines AG Companies of Johnson & Johnson on vaccination Plant (Fermenter, Separator and Tanks)   system with software Process Management Control System (PMCS) like SCADA HMI, GAMP 5 customized software    

He worked as a Senior Consultant for the company Boehringer Ingelheim at packaging line tracking system with serialisation & aggregation software, resposible for Validation and regulatory validation documents

As a GMP Advisor he worked for a company Elanco/Lohmann  Animal Health and was responsible for  GMP critical systems , creating compliance documents (Sytemdescription, URS, RA, and Traceability Matrix), focused on Internal training Software  and  remote suppliers  maintenance.

As a Legacy Reviewer and Supplier Process Validation Control, DePuy Synthes companies of Johnson & Johnson

He was successfully validated on June 2013 DMS (document management system) for GMP environment on the base of Share Point and Nintex workflow, also prepared validation documents for  chromeleon Software, WELEDA AG 

Among many firms he worked also for the following companies,
as a Validation  and Application Manager successfully and completely validated two software; PMX CTM (Clinincal Trial Monitoring) and update new version Validat 5.59 (Statistical Data Collection and Evaluation) software, Hexal AG / Sandoz -a Novartis Company, Pharma Test Apparatebau AG, Erweka GmbH, Logica GmbH, Laker Vertriebs GmbH, Walter Bock Pharma GmbH,  Maximilian University. He gathered experience  abroad, for example Eastern and West Europe, Middle East Countries and Africa

Qualification & Validation Experts for Lab Devices, was founded in the year 2010. We are a dynamic, continuously growing small company based in the Rhein Main area, Hessen, Germany. We offer a service nationally & internationally for all  your needs in the issues of qualification, validation, Creating Regulatory documents for laboratory equipment and software such as analytic, galenic, spectrophotometer, fully automated dissolution system.

Creating a new regulatory qualification and validation documents or  completion of available documents such as Validation plan, IQ, OQ,  HLRA, RA, System Documentaion, Traceability Matrix, Validation Reports. Implementing Mitigation plan such as User  periodic review, Change management, Incident management and DRP (Disaster Recovery Plan), checking and controlling Database , having profound experience in VALIDAT (statistical data record  and analysis software) , PMX CTM (Clinical Trial Monitoring Software), Administering Manufacturing Execution System (MES) pharmaceutical production software.

Our services range from basic research up to qualification of entire
production plants, advising and consulting for new purchases, also
establishing of qualified documents for existing plants.

The following References are available upon request:

- SANDOZ / HEXAL AG as a business unit of  Novartis

 -  WELEDA AG

-  Depuy Synthes companies of Johnson & Johnson

-  Boehringer Ingelheim

- Lohmann Animal Health GmbH/Elanco Animal Health

- Janssen Vaccines AG Companies of Johnson & Johnson

- F. Hoffmann-La Roche Ltd