Buerger-Consulting contributes , thru Supporting IT Setting , to Business Innovation of Pharmaceutical Manufacturers
As we have been helping setting up of IT system for a variety of pharmaceutical manufacturing firms so as to share environmental change and problems they have been facing to, materialization of optimal IT system can be offered to our clients in this industry. We are sincerely hoping to help our clients having excellent idea/plan to whom we may contribute for business innovation of pharmaceutical manufacturers by supporting IT system setting up.
The followings are main domain of IT system setting up of pharmaceutical manufacturers we have helped .
Introduction Support to Documentation Management
Support to process system construction for eCTD ( electronic application of new drugs) is done by our consultant with abundant experience & knowhow of eCTD documentation management. Support to various electronic documentation for SOP, Planning/reporting document, product standardization, attached document, etc., in addition to eCTD can be offered.
Introduction Support to Word Template
Our consultant with high professional skill knowing details of task to produce application form to which field responsible personnel is facing helps improvement of quality & efficiency in producing application document with word template as an optimal solution n its center form based upon a plenty of actual examples.
Support to CSV, ER/ES
Our consultant dealing policy making and guideline setting of CSV or ER/ES for many pharmaceutical firms in past supports to establish these policy& guideline and provides training of documentation management,eCTD,CSV(for Part 11) & ER/ES.
Support to DI(Data Integration)
Dealing with DI(data integration) is an urgent matter at this moment. Our consultant who has been handling DI at pharmaceutical firms so far may help you. We support you for DI policy setting/SOP making, ER/ES policy/SOP revision, ion, paper document policy/SOP revision, check list making for DI at purchasing equipment/system, check /evaluation/counter-measure list for equipment/system making,etc., are supported by us.
Execution of Group Audit
Auditing vendors is indispensable when introducing IT system at pharmaceutical manufactures.
Buerger-consulting helps such an audit. Group audit which common auditing with plural firms for common use of the same IT system among them is also helped by Buergar-consulting. Advantage of group audit is to save cost and to avoid omission of standardized audit items.
Support to Quality Event Management System
Our consultant experienced in quality event management of GMP, therapeutic medication GMP, GQP supports arrangement of business requirement for structure of event management system. Introduction study, construction, and operation for quality event control system of business of various omission/change/CAPA/claim management and their audit are also supported by us.
Support to introduction/construction/operation of IT system, whether or not different type of the system , is supported by us as the following details.
Introduction Study of IT System
For introduction of IT system, pharmaceutical firms require feasibility study on screening targeted business, vendor selection(producing proposal request/comparison sheet/selection result),and requirement definition all of which we may support.
Construction of IT System
For construction of IT system, pharmaceutical firms confirm requirement refers to function & setting of IT system to plan , execute and report testing for acceptance of user. Educating users must be done in producing manual and the related data. Execution of CSV activity must be also done and its documentation is necessary. All of the above can be helped by us.
Operation of IT System
For operation of IT system,pharmaceutical firms study business operation using IT system, establish its operation rule, and organize operation team to start with. Change/omission management of IT system must be done. All of the above can be helped by us too.
The following is some example of our consulting done.
Support to Introduction of Documentation Management System
|Case||Support to introduction of application document management system related to eCTD.|
|Client||A major pharmaceutical manufacturer :R&D,pharmaceutical affairs,QA,IT departments.|
|Task||Restructure of application document producing process for construction of new eCTD system.|
|Consulting||Promoting project in effectively guiding difficult points for decision making in showing a plenty
of examples on competitors ‘/industry’s trend.
|Performance||Successfully introduced new system as expected upon completion of definition of optimal high quality process and system requirement.|
Support to Introduction of Word Template
|Case||Support to introduction of Word template related to eCTD.|
|Client||A major pharmaceutical manufacturer:R&D,pharmaceutical affairs, QA,IT departments.|
|Task||Realization of improvement of both of quality & efficiency for application document.|
|Consulting||Accurately supporting client to produce Word template with our abundant experience and professional skill.|
|Performance||Realized making high quality standard document with Word template without any hesitation.|
Support to CSV,ER/ES related
|Case||Support to making ER/ES policy & guideline.|
|Client||A major pharmaceutical manufacturer:CSV related department.|
|Task||As ER/ES policy/guideline is not existing in house, it was so hard to explain importance of IT introduction.|
|Consulting||Promoting project to demonstrate abundant competitors’ example and industry trend and effectively guiding to eliminate difficult obstacles for decision making.|
|Performance||Considering regulation as well as internal requirement, optimal guideline and policy for ER/ES were set up and inter-office training was done.|
Support to DI(Data Integration)related
|Case||Support to DI related|
|Client||A Major pharmaceutical manufacturer:Quality Control Department.|
|Task||Hard to do inner office study checking response to DI/evaluation because check list of response to DI was not yet prepared.|
|Consulting||Promoting project to effectively guiding difficult point to be judged in demonstrating competitors’/industry’s trend.|
|Performance||Prepared check list related to DI in considering both of regulation and inner office situation and supported to equipment purchase.|
Execution of Group Audit
|Client||Plural number of pharmaceutical related firms in JSQA(Japan Society of QA Study)|
|Task||Vendor audit of Fujitsu’s DDwork21(Cloud Service) in saving cost & man-hour.|
|Consulting||Proposing hearing to vendor and doing field survey after receiving response from vendor. Producing audit report summing up these activities at all.|
|Performance||Considered both of regulation requirement and utilization situation of each firms, optimal vendor check list was made and received response. Field survey was also done.|
Support to Introduction of Quality Event Management System
|Case||Support to study of introduction & construction of GMP event management system.|
|Client||A major pharmaceutical manufacturer :GMP,QA,IT departments.|
|Task||estructure of business process of GMP event (omission,change,CAPA)management and construction of IT system.|
|Consulting||Demonstrating competitors’ examples, promoting project in guiding point being difficult to judge .|
|Performance||Achieved definition of high quality optimal process & system requirement to introduce new system as expected.|