| | SLO | ENG | Cookies and privacy

Bigger font | Smaller font
First page > Show document

Show document Help

Title:ZAGOTAVLJANJE REGULATORNE SKLADNOSTI RAČUNALNIŠKIH SISTEMOV V FARMACEVTSKI INDUSTRIJI
Authors:ID Zupin, Gašper (Author)
ID Leskovar, Robert (Mentor) More about this mentor... New window
Files:.pdf MAG_Zupin_Gasper_2016.pdf (1,43 MB)
MD5: 3B12301FC0DA8EC41A81EC5F5BCC68DE
 
Language:Slovenian
Work type:Master's thesis/paper
Organization:FOV - Faculty of Organizational Sciences in Kranj
Abstract:Magistrsko delo obravnava zagotavljanje regulatorne skladnosti računalniških sistemov v farmacevtski industriji. Obravnava načine obvladovanja in zagotavljanja skladnosti računalniških sistemov, opiše delovanje in pomen regulatornih organov, ki bedijo nad delovanjem farmacevtske industrije in predstavi ključni regulatorni direktivi za področje računalniških sistemov v reguliranem okolju 21 CFR PART 11 ameriške agencije za hrano in zdravila FDA (ang. Food and Drug Administration) in ANEX 11 evropske agencije za medicino EMA. Na primeru konkretne farmacevtske organizacije predstavi koncept validacije računalniških sistemov v farmacevtski industriji, definira deležnike in njihove odgovornosti, kategorizira sisteme, navaja seznam potrebne validacijske dokumentacije in pripravo končnega validacijskega poročila. Izpostavi pomembnost vzdrževanja regulatorne skladnosti računalniškega sistema skozi življenjski cikel sistema, predstavi zagotavljanje pravilnega delovanja v povezavi z upravljanjem z incidenti, odstopi, spremembami in ostalo varnostno politiko, ki zagotovi, da sistem ostaja primeren za produkcijsko delovanje glede na uporabniške in regulatorne zahteve. V primeru nepravilne implementacije in upravljanja sistema predstavlja odstopanje glavni izziv s katerim se lahko sreča farmacevtsko podjetje. Odstopanja prepoznana s strani zunanje regulatorne organizacije kot je na primer FDA lahko privede do nepredvidenih stroškov, izgube ugleda družbe in v najbolj drastičnih primerih prepoved proizvodnje in distribucije zdravil. V študiji primera je analiziranih zadnjih 50 opozorilnih pisem ameriške agencije FDA s področja računalniških sistemov v farmacevtski industriji glede na frekvenco pojavnosti. Prepoznane kritične tematike in predstavljeni razlogi za pojav, kot so manjkajoči splošni postopki in brisanje izvornih podatkov računalniškega sistema, so lahko farmacevtskemu podjetju v pomoč pri fokusiranju na najbolj aktualna področja zagotavljanja regulatorne skladnost. Zaradi kompleksnosti zagotavljanja skladnosti, posledično velikih naporov in visokih stroškov za podjetje in vse bolj natančnih pregledov inšpektorjev, naloga podaja predloge kako bi podjetje lahko preprečilo pojav nepravilnosti prepoznanih s strani regulatornih organov na inšpekcijskih pregledih. Z analizo opozorilnih pisem je bilo ugotovljeno, da lahko podjetje s pravilnim pristopom, doslednim upoštevanjem regulative in z zadostnim vložkom v ljudi in tehnične rešitve preide v stanje, ki je skladno z regulatornimi zahtevami in pričakovanji zunanjih inšpektorjev. Tako se podjetje v vse bolj konkurenčni farmacevtski industriji lahko osredotoči na svojo primarno poslanstvo: razvoj in proizvodnjo visoko kakovostnih in varnih zdravil za paciente, ki jih potrebujejo.
Keywords:Regulatorna skladnost računalniškega sistema, Regulatorni organ, Validacija Življenjski cikel, Odstopanje in opozorilno pismo
Place of publishing:Maribor
Year of publishing:2016
PID:20.500.12556/DKUM-59674 New window
COBISS.SI-ID:7631379 New window
NUK URN:URN:SI:UM:DK:VIWR5WWP
Publication date in DKUM:01.07.2016
Views:1937
Downloads:168
Metadata:XML DC-XML DC-RDF
Categories:FOV
:
Copy citation
  
Average score:(0 votes)
Your score:Voting is allowed only for logged in users.
Share:Bookmark and Share



Hover the mouse pointer over a document title to show the abstract or click on the title to get all document metadata.

Secondary language

Language:English
Title:ENSURING REGULATORY COMPLIANCE OF COMPUTER SYSTEMS IN PHARMACEUTICAL INDUSTRY
Abstract:The work explains how to ensure regulatory compliance for computerized systems in pharmaceutical industry. It describes different ways of controlling and ensuring computerized systems regulatory compliance, explains how the regulatory agencies operate and present a key regulatory standards for computerized systems – American government agency FDA (Food and drug administration) standard 21 CFR PART 11 and European agency for medicine standard EMA ANEX 11. On the case of concrete pharmaceutical company the thesis describes the concept of validation of computerized systems in pharmaceutical industry, defines stakeholders and their responsibilities, categorizes computerized systems, and lists the necessary validation documentation and preparation of the final validation report. The work outlines the importance of maintaining the regulatory compliance throughout the life cycle of computerized system. Furthermore, it explains, how to maintain proper performance of the system with regards to incidents, deviations, changes and other relevant security politics management, which altogether ensure the system suitability for production according to user and regulatory requirements. If the system is not implemented and managed properly, the deviations can represent a major challenge for pharmaceutical company. Deviations recognized from external regulatory agency, such as FDA can, can lead to unexpected costs, loss of company reputation and in the most drastic cases prohibition to distribute and sale drugs to end customers. This case study analyzes the last 50 FDA warning letters for computerized systems in pharmaceutical industry based on the frequency of their occurrence. The identified critical topics and reasons for receiving warning letters, such as lack of internal procedures or deleting the raw data, could help pharmaceutical company to focus on most current topics of regulatory compliance for computerized systems. Ensuring compliance of the systems is very complex, consequently, great effort and high costs are needed to handle the systems and to deal with more and more detailed inspections. Therefore, the master thesis proposes how company should deal with compliance risks in order to prevent the deviations and their discovery during inspections. Analysis of warning letters showed that with the proper approach, strict compliance with regulations and adequate investment in human reassures and technical solutions, company can move up to the level where they will meet regulatory requirements and, consequently, expectations of inspectors. A company in an increasingly competitive pharmaceutical industry can then focus on their primary mission: to develop and produce high quality and safe medicines for patients who need them.
Keywords:Computerized system regulatory compliance, Regulatory agency, Validation Lifecycle management, Deviation and warning letter


Comments

Leave comment

You must log in to leave a comment.

Comments (0)
0 - 0 / 0
 
There are no comments!

Back
Logos of partners University of Maribor University of Ljubljana University of Primorska University of Nova Gorica