21 CFR Part 11 Compliance Checklist

The regulations outlined in 21 CFR Part 11 set the ground rules for automated record keeping systems for organizations subject to FDA oversight. By affirming that electronic records and signatures are equally as legitimate as paper records and handwritten signatures, Part 11 has given companies the opportunity to automate and streamline manufacturing and quality processes. A 21 CFR Part 11 compliance checklist can guide you through the maze of regulatory requirements and help your organization meet the appropriate compliance standards.


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Get insider information about the most relevant issues in 21 CFR Part 11 Compliance today, and how to navigate and overcome the complexities of FDA Regulations.

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White Papers
  • Learn five "Good System Implementation Practice" tips covering key system SOPs, user authentication, access security, audit trail and record retention - the essential components of a Part 11-compliant system.
  • Learn how automated document control solutions help organizations better manage corrective and preventive actions (CAPA), change control, training, and many more quality processes. It focuses on document control processes within the quality system lifecycle and provides insight into the capabilities needed to automate change control processes that will increase efficiency, ensure compliance with regulatory requirements and improve overall profitability.
  • A lack of quality can cost an organization millions of dollars in rework, scrap, recall or even liability lawsuits. This white paper shows how an optimized quality management system (QMS) can help a company avoid quality roadblocks and form the foundation for long-term regulatory compliance and, ultimately, for ensuring market success.

Product Information

Discover how MasterControl Document COntrol Software can manage your 21 CFR Part 11 process, all while mitigating risk, improving speed-to-market, and generating ROI.

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Product Data Sheets
  • The MasterControl Documents software solution automates and effectively manages the document control process to help companies ensure compliance with regulatory requirements. It automates all document routing, delivery, escalation and approval processes and makes the search for and retrieval of documents easy during audits or inspections.

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  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.


Compliance Confusion? Stay on Track with This 21 CFR Part 11 Compliance Checklist


If your company is planning to convert to an automated system for managing documents and business processes, make sure that the new system meets the needs outlined in the following 21 CFR Part 11 compliance checklist:

  • 21 CFR Part 11 requires an assurance of the authenticity of electronic records. To maintain compliance, system administrators need to have a system that offers the ability to delineate user permissions for every document vault in the system. The system must also be able to generate an audit trail for any captured document.
  • The potential for a signer to repudiate an approval must be minimized. An automated system meeting the requirements of the 21 CFR Part 11 checklist should require users to enter two passwords to approve any type of document collaboration, one password for login and another for approval.
  • The FDA requires that the electronic system must be validated. Implementation of an electronic system with a proven track record of performance and validation can drastically reduce the time and money a company devotes to its overall validation efforts. Depending on the company's internal corporate policies and risk evaluations, validation can be as simple or as thorough as the electronic system will allow.
  • According to 21 CFR Part 11, all users who have been approved to use the electronic system must be sufficiently trained to perform their assigned duties. A system that incorporates automated training capabilities can provide automatic triggers when an essential quality document is revised in order to ensure sustained 21 CFR Part 11 compliance. A system with a proven training component should also be able to automate the follow-ups and escalations of past-due training tasks as well as create audit trails for all training data.
  • Document controls must provide revision controls, change controls, and time-based system modifications. In these regards, an organization's internal business processes and specific corporate protocols must be evaluated in order to determine what is needed to formulate an individualized 21 CFR Part 11 compliance checklist.
  • 21 CFR Part 11 compliance requirements also mandate that signed electronic records include the following data: name, date and time of signing, and meaning of signature. An effective electronic system should provide fields for all such required information to ensure 21 CFR Part 11 compliance as well as for supplementary information (if such fields are desired for use).
  • Electronic (and handwritten) signatures must be able to be linked to their corresponding electronic records. An established electronic system should easily be able to link every signature with a specified record.


MasterControl Solutions Meets the Criteria of the 21 CFR Part 11 Compliance Checklist


Within one year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with the regulations delineated in 21 CFR Part 11. Now, hundreds of companies worldwide rely on the MasterControl integrated business process management solution suite to achieve and sustain 21 CFR Part 11 compliance. Not only do MasterControl's solutions meet each of the components listed in the 21 CFR Part 11 compliance checklist above, but they also streamline and automate GxP processes and facilitate effective management of document control, change control, training management, audits, corrective/preventative action (CAPA), customer complaints, and other quality processes, all within a single Web-based application.


Specific Sections of 21 CFR Part 11 Addressed by MasterControl


Here are just a few examples of particular sections of the regulation that MasterControl can help you cross off your 21 CFR Part 11 compliance checklist:

  • Part 11 Section 11.10 - MasterControl software solutions ensure authenticity, integrity, and confidentiality of electronic records
  • Part 11 Section 11.10 - MasterControl minimizes the possibility of repudiation by signer
  • Part 11 Section 11.10 a - The system can be fully validated according to the FDA's guidelines
  • Part 11 Section 11.10 I - MasterControl facilitates proper training (and tracking of training) for system users
  • Part 11 Section 11.10 k - MasterControl provides appropriate controls over system documentation including access to documentation for system operation and revision and change control procedures
  • Part 11 Section 11.50 a - The MasterControl solution ensures that electronically signed documents contain the name of the signer, time and date of the signing, and the meaning of signature
  • Part 11 Section 11.70 - MasterControl allows electronic signatures and handwritten signatures executed to electronic records to be linked to their respective electronic records


MasterControl Has the Answers to Your 21 CFR Part 11 Compliance Checklist


Looking to add other specific components to your company's distinctive 21 CFR Part 11 compliance checklist? The MasterControl team is always available to answer your questions and let you know how we can help. Call us toll free at 800-825-9117 or contact MasterControl online for more information.

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