Welcome to the USA Website

We have detected that you may prefer the Global site. Please use the language dropdown above to change your selection if required.

Go to Global

It is not always necessary to replace your legacy systems to comply with current regulations…

The “Wrap & Comply” concept looks at working with your current system components to minimize your validation effort.  Maximizing the re-use of hardware and software will enable you to “Wrap” your legacy system in a compliant architecture in order for the GxP system to “Comply” with regulatory requirements including the FDA’s 21 CFR Part 11.

Save time and money…

  • Re-use existing hardware
  • Re-use existing software
  • Minimize SOPs
  • Improve plant efficiency and quality
  • Faster time to market
  • Reduce validation

Let us help you identify the non-compliant systems and take the necessary remediation action to validate them:

  • Gap analysis – Identify computer system validation gaps
  • Coverage Assessment – Determine which GxP rules must be satisfied
  • Risk Assessment – Determine and prioritize potential compliance actions
  • Mitigation/Remediation Plan – Formulate a corrective action plan addressing the deficiencies following the rule: “Maintain as much of the existing hardware and software as possible”
  • Implementation – Implement corrective actions

Product Selector

Package icon
Need help choosing the right product?

Our tool will match the best product to your needs

Launch product selector

Contact Us

Request Information

Support Center

Find a Distributor

close
close

Cookies and privacy

Our website uses cookies delivered by us and by third parties. Some cookies are necessary for the website’s operation, while others can be adjusted by you at any time, in particular those which enable us to understand the performance of our website, provide you with social media features, and deliver a better experience with relevant content and advertising. You may accept them all or set preferences.

Accept All
Reject All

Privacy Settings

Necessary cookies

Necessary cookies are required for our website to work properly and can’t be turned off. They are sent to your computer or device when you request a specific action or service, e.g. when you log in, fill out a form, or set your cookie preferences. If you set your browser to block or alert you about these cookies, certain parts of our website won’t work.

Statistical cookies

Thanks to statistical or analytical cookies, delivered by us and other companies, we can count the visits on our website and know the sources of traffic. The data we derive helps us understand what visitors like most and improve the website. If you don’t accept them, we won’t be able to improve your experience based on data from your visit.

Customization cookies

Customization cookies allow you to configure our website to your preferences (e.g. language, region) and enable enhanced functionalities. They are delivered by us or by other companies. If you don’t accept them, we won’t be able to save your preferences and some services on our website may not be available.

Marketing cookies

Marketing cookies on our website are delivered by other companies and used to identify your interests and display relevant advertising content when you browse outside of our website. These cookies can enable social media features such as sharing and simplifying registration. If you do not accept them, you will still see online ads, but they will be less relevant.

Save Settings