/Library
Free trial
/Library
 Turn Complex Regulations into Clear, Actionable Tasks: Introducing TenForce Compliance Calendar
Free trial
Guides

The Ultimate Guide to FDA 21 CFR Part 11 Compliance

When it comes to compliance, FDA 21 CFR Part 11 is crucial for businesses in the American market. Focusing on data integrity, audit trails, system access, and user training, failure to comply with these regulations can result in fines, market withdrawal, reputational damage, or even license revocation.

TenForce’s eQMS software simplifies 21 CFR Part 11 compliance for pharmaceutical companies. Our quality management suite ensures data accuracy, smooth operations, and effortless regulatory adherence. With features like secure document management, reliable electronic signatures, automated audit trails, and robust user authentication, you can manage compliance with confidence.

Why stress about compliance when you can turn it into an advantage? With TenForce, staying compliant becomes an effortless part of your workflow, safeguarding your business and reputation. Curious to see how it works? Download our Ultimate Guide.

Privacy Preference Center

Required
Always Active

These cookies are needed to provide basic functionalities as you browse around the TenForce website. These capabilities include cookie preferences, load balancing, session management, language selection and checkout processes. These cookies ensure the site is performing the requested task and collect data for audit purposes. The information that is collected is aggregated for analysis.

Example Functionality Allowed
  • Enable cookie consent collection and enforcement Remember log-in to provide secure transactions across web pages, provide secure log-in, cloud systems management, authentication, load balancing, user interface language/font preferences and single sign-on
  • Keep track of the user's input while filling online forms, shopping carts for the duration of the session or for up to 24 hours after the session
  • Remember your transaction progress for the duration of the session
  • Multimedia content player cookies, used to store technical data to playback video or audio content, for the duration of a session
  • Third‑party social plugin for sharing logged‑in state for members of a social network.
Example Functionality NOT Allowed
  • Remember your log-in details
  • Remember what is in your shopping cart
  • Make sure the website looks consistent
  • Allow you to share pages with social networks
  • Allow you to post comments
  • Serve ads relevant to your interests

Functional Cookies

These cookies are used to capture and remember user preferences on the TenForce website for a longer period of time and enhance the usability of our websites or to pre-fill forms. The information is aggregated for analysis for anonymous users, but if you sign-in, we keep the data provided to perform the functions requested. Additionally, we use data to enable social interactions and site optimization.

Example Functionality Allowed
  • Enable cookie consent collection and enforcement
  • Remember log-in to provide secure transactions across web pages, provide secure log-in, cloud systems management, authentication, load balancing, user interface language/font preferences and single sign-on
  • Keep track of the user's input while filling online forms, shopping carts for the duration of the session or for up to 24 hours after the session
  • Remember your transaction progress for the duration of the session
  • Multimedia content player cookies used to store technical data to playback video or audio content, for the duration of a session
  • Third‑party social plugin for sharing logged‑in state for members of a social network.
  • Remember your log-in details
  • Remember what is in your shopping cart
  • Make sure the website looks consistent
Example Functionality NOT Allowed
  • Allow you to share pages with social networks
  • Allow you to post comments
  • Serve ads relevant to your interests

Personalization Cookies

These cookies are used to improve the overall experience of your visit to the TenForce, by personalizing messaging based on browsing history, profile data, purchase history and improve our social media and paid media marketing campaigns. The data collected is aggregated for analysis for anonymous users, but if you sign-in, we keep the data provided to perform the functions requested.

Example Functionality Allowed
  • Enable cookie consent collection and enforcement
  • Remember log-in to provide secure transactions across web pages, provide secure log-in, cloud systems management, authentication, load balancing, user interface language/font preferences and single sign on
  • Keep track of the user's input while filling online forms, shopping carts for the duration of the session or for up to 24 hours after the session
  • Remember your transaction progress for the duration of the session
  • Multimedia content player cookies used to store technical data to playback video or audio content, for the duration of a session
  • Third‑party social plugin for sharing logged‑in state for members of a social network.
  • Remember your log-in details
  • Remember what is in your shopping cart
  • Make sure the website looks consistent
  • Allow you to share pages with social networks
  • Allow you to post comments
  • Serve ads relevant to your interests