fbpx

radixintegratedsolutions.com

CSV and ISO27001

CSV and ISO 27001

CSV (Computer System Validation) is often considered as software validation. Now big enterprises perform validation projects to prove that their software or system is performing the way it is supposed to work, and not performing in ways that it isn’t intended to work. Computer systems include all the complementary equipment that supports the system as well as its users as a whole. 

ISO 27001 Information Security Management System describes organisation’s approach to information security and privacy for the system. It will help to identify and address the threats and opportunities around our valuable information and any related assets. ISO 27001 guidelines protects our organisation from security breaches and control it from disruption if and when they do happen

Information security is one of the concerns of the modern organisation. The volume and value of data used in everyday business increasingly informs how organisations operate and how successful they are. In order to protect this information – and to be seen to be protecting it – more and more companies are becoming ISO 27001 certified.

For ensuring Pharmaceutical IT compliance we have to implement ISO 27001 Information Security Management system along with CSV aligned with 21 CFR part 11.

The last few years have seen corporate governance requirements become increasingly more defined and specific. Information technology has become more pervasive – underpinning and supporting almost every aspect of the organisation.

The ISO 27000 family of standards offers a set of specifications, codes of conduct and best practice guidelines for organisations to ensure strong IT service management.

For implementation this system , we have to complete  Gap Assessment against ISO 27001:2013 ,CSV, GAMP 5.0 and 21 CFR11 requirements and Creation of Statement of Applicability (SOA) based on the Gap Assessment report.

After GAP Assessment we have to create ISO27001 Manual, Mandatory Procedures, Work Instruction, Formats etc. required for implementation of ISMS. We have to align CSV (Computer System Validation), GAMP 5.0 & 21 CFR11 guideline alignment with ISO 27001 standard.

Risk analysis of ISMS ISO 27001 with Department head including Production, HR, QC, IT, QA, Engg, Store etc. is required for maturation of the system

Achieving ISO 27001 certification is a valuable and visible proof of Our Plant as well as organization’s willingness to meet internationally-accepted data security standards. Achieving this international standard is not simply branding & marketing but also the ability to prove that our organization complies with ISO 27001 is likely to open business opportunities across the globe.

How ISO 27001 is useful for Access Control

Access Control Policy

In any organisation an access control policy is must be established, documented and reviewed regularly for Information Security in place for the assets in scope.

Any company’s Access control rules, rights and restrictions along with the depth of the controls should reflect the information security risks around the information and the enterprise’s appetite for managing them.

Access to Networks and Network Services

Least access principle is the general approach for protection, rather than unlimited access and super user rights without mindful consideration.

Company should think about to whom get access for network. Only key employee should get Network and network services access who know to use as per their job. The policy therefore needs to address; the networks and network services in scope for access; Authorisation procedures for showing who is allowed to access to what and when.

User Registration and Deregistration

A company who is keen to implement ISO27001 there should be a formal user registration and deregistration process needs to be implemented.

A good on-boarding and exit process aligned with Human Resource Security to show quick and clear registration/deregistration along with avoidance of reissuing old IDs.

There should be a regular review of ID’s will illustrate good control.

User Access Provisioning

Any company who aspire ISO27001 or a good system for information security must be implement to assign or revoke access rights for all user types to all systems and services. It should be aligned with HR Security work.

There should be Verification process for access granted is relevant to the role being done; and protecting against provisioning being done before authorisation is complete.

Management of Privileged Access Rights

Privileged access right is more powerful and higher ‘privileged’ levels of access e.g. systems administration permissions versus normal user rights.

System for allocation and use of privileged access rights should be tightly controlled given the extra rights usually conveyed over information assets and the systems controlling them.

Information Access Restriction

For implementing information Security system in any company, the focus area should be access to information and application system functions which must be tied into the access control policy.

What are the considerations when we are going to put information Access Restrictions are-

  • Levels of access;
  • Role-based access control (RBAC);
  • Read, write, delete and execute permissions;
  • Limiting output of information;
  • Design of “menu” systems within applications;
  • Physical and/or logical access controls to sensitive applications, data and systems.

Secure log-on Procedures

Log on Procedure must be fool proof. In any organisation access to systems and applications must be controlled by a secure log-on procedure to prove the identity of the user.

We are typically put password approach, this can go beyond password approach into multi-factor authentication, biometrics, smart cards, and other means of encryption. We have to do Risk management and whenever we do risk management we should consider log on procedure in depth. We have to see ISO27002 guideline for this procedure

Password Management System

Password management system is a good way to reduce the risk .The purpose of a password management system is to ensure quality passwords meet the required level and are consistently applied.

Password generation and management systems provide a better path for centralising the provisioning of access and they serve to reduce the risk of people using the same login for everything.

Along with any other control approach, password generation and management systems need to be carefully implemented adequate levels of protection.

32 thoughts on “CSV and ISO27001”

  1. dfg
    Right here is the right webpage for everyone
    who wants to understand this topic. You know so much its almost hard to argue with
    you (not that I actually will need to…HaHa). You certainly put
    a new spin on a topic that’s been discussed for ages.
    Wonderful stuff, just wonderful!

  2. Greetings! This is my first comment here so I just wanted to
    give a quick shout out and say I truly enjoy reading your posts.
    Can you recommend any other blogs/websites/forums that go over the same subjects?
    Appreciate it!

  3. Fantastic goods from you, man. I have understand your stuff previous to and you are just too fantastic.

    I actually like what you’ve acquired here, really like what you’re stating and the way in which you say it.
    You make it enjoyable and you still care
    for to keep it sensible. I can not wait to read far more from you.
    This is actually a tremendous website.

  4. You really make it seem so easy along with your presentation but
    I in finding this matter to be really something
    that I think I might never understand. It sort of feels too complicated and extremely broad for me.
    I am having a look ahead on your subsequent submit,
    I will attempt to get the hold of it!

  5. fantastic post, very informative. I ponder why the other specialists of this sector do not understand
    this. You must proceed your writing. I’m confident, you’ve a
    great readers’ base already!

  6. Having read this I thought it was extremely informative.
    I appreciate you finding the time and energy to put this article together.
    I once again find myself personally spending a lot of time both reading and leaving comments.
    But so what, it was still worth it!

  7. Great post. I was checking continuously this weblog and I’m inspired!
    Very helpful info specially the ultimate phase 🙂 I maintain such info much.

    I was looking for this certain info for a very long time.
    Thanks and best of luck.

  8. Can I simply just say what a comfort to discover someone that genuinely knows what they’re discussing online.
    You certainly know how to bring a problem to light and make
    it important. More people really need to read this and understand this side of the story.

    I was surprised you’re not more popular since you certainly possess the gift.

  9. We stumbled over here coming from a different page and thought I may as well check things out.

    I like what I see so now i’m following you.
    Look forward to finding out about your web page repeatedly.

  10. Thank you, I have just been searching for information about this topic for a long time and
    yours is the greatest I have came upon till now. But, what
    in regards to the bottom line? Are you positive concerning the source?

  11. Hello! I could have sworn I’ve been to your blog before but
    after browsing through many of the articles I realized it’s new to me.
    Anyways, I’m definitely happy I found it and I’ll be bookmarking it and checking back
    frequently!

  12. Great article, exactly what I wanted to find.

    https://maingameslotonline52965.aboutyoublog.com/19568529/about-primary-game-port-online
    https://gameslotonlineterbaik44952.blog2news.com/19760924/leading-ideal-online-ports-games-tricks
    https://slot-games-online-free22213.blog4youth.com/19290717/just-how-much-you-required-to-expect-you-ll-pay-for-a-good-kode-rahasia-video-game-port-online
    https://andregadtz.blog5star.com/19748774/every-little-thing-regarding-video-game-slot-online-terbaik
    https://gameslotonlineterbaik23311.blogdun.com/19710994/daftar-video-game-port-online-an-summary
    https://devinvxftk.popup-blog.com/17809997/attraction-regarding-nama-video-game-port-online
    https://game-slot-online-terbaik44662.goabroadblog.com/17862962/little-understood-realities-about-port-games-on-the-internet-cost-free
    https://trevormvaeu.bloggactif.com/20295404/5-tips-regarding-primary-game-port-on-line-you-can-utilize-today
    https://game-online-688-slot80932.bloguerosa.com/17879970/a-trump-card-for-ideal-on-line-slots-games
    https://archerioqto.blogginaway.com/19824254/reported-buzz-on-port-games-online-free
    https://maingameslotonline62663.blogolenta.com/20140195/leading-game-online-688-port-tricks
    https://sethwvgll.daneblogger.com/17892469/main-game-slot-online-alternatives
    https://charliesgqly.blogozz.com/17877100/reported-buzz-on-slot-games-on-line-free
    https://maingameslotonline42356.blogripley.com/19864186/major-game-port-on-the-internet-can-be-enjoyable-for-anybody

  13. I used to be suggested this web site by means of my cousin. I am not
    positive whether or not this publish is written by
    way of him as no one else know such certain about my difficulty.
    You are incredible! Thank you!

  14. I have been exploring for a little bit for any high-quality articles or blog posts on this
    sort of space . Exploring in Yahoo I finally stumbled upon this website.

    Reading this info So i’m glad to express that I have an incredibly just right uncanny feeling I discovered exactly what I needed.
    I most definitely will make sure to do not forget this web site and give it a look regularly.

  15. Great goods from you, man. I’ve understand your stuff previous to and you are just extremely fantastic.
    I actually like what you’ve acquired here, certainly like what you’re stating and the
    way in which you say it. You make it entertaining and you
    still care for to keep it sensible. I can’t wait to read much more from you.
    This is actually a great web site.

  16. I’m really inspired together with your writing talents as well
    as with the format on your weblog. Is that this a paid theme
    or did you customize it yourself? Either way keep up the excellent quality writing, it’s rare to peer a nice blog like
    this one today..

  17. Pretty nice post. I just stumbled upon your blog and wanted to
    say that I’ve truly enjoyed browsing your blog posts.

    In any case I will be subscribing to your rss feed and
    I hope you write again very soon!

  18. Magnificent items from you, man. I have consider your stuff previous to and you’re just too magnificent.
    I actually like what you’ve received here, really like what you are stating and the way
    in which through which you say it. You’re making
    it entertaining and you still care for to keep it smart. I can not wait to learn far more from you.
    This is actually a tremendous site.

Leave a Comment

Your email address will not be published. Required fields are marked *