21 CFR Part 11 Compliance Software
QMS software for life science organizations that ensures compliance with the complex FDA 21 CFR Part 11 software requirements for electronic records and electronic signatures.
Stop wasting time on wet signatures and manual document flows
FDA 21 CFR Part 11 requirements apply to organizations within the FDA-regulated industries that manage electronic records and signatures.
SimplerQMS fully complies with all these requirements and allows life science organizations to manage any quality record digitally and avoid using paper. We take full regulatory responsibility for your eQMS so you don’t have to invest in specialized competencies for meeting the specific compliance requirements for processes like electronic signatures, implementation, and validation.
Ensure 21 CFR Part 11 compliance
SimplerQMS is a 21 CFR Part 11 compliant software system, designed to help Life Science organizations comply with the Electronic Signature and Digital Record practices set forth by the US FDA’s 21 CFR Part 11.
Sign and send documents from anywhere with electronic signatures
Our 21 CFR Part 11 compliant software system provides built-in Electronic Signatures that are compliant with the FDA 21 CFR Part 11 regulatory framework. This means that all records are signed electronically and automatically capture the name, date, and time when the signature was executed, as well as the meaning (e.g., authorship, review, or approval) related to the signature.
Streamline your documentation processes
SimplerQMS provides robust, 21 CFR part 11 compliant document management system features such as automatic naming, numbering, and versioning of your documents. Automated workflows simplify document review and approval processes and ensure that the relevant persons are notified when they are assigned a task. The system integrates with Microsoft Office applications – Word, Excel, Outlook, PowerPoint, and allows you to save a document with one click in SimplerQMS Cloud.
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Get computer-generated, time-stamped audit trails
SimplerQMS follows 21 CFR part 11 audit trail requirements and provides secure, computer-generated, time-stamped audit trails to record every creation, modification, and deletion of any digital record.
Avoid computer system validation activities
SimplerQMS is a pre-validated software solution that complies with the computer system validation requirements of the FDA 21 CFR Part 11, ISO 13485:2016, and GxP guidelines. This means that you won’t need to spend time and money resources on computer system validation processes required for the FDA 21 CFR Part 11 complaince.
What kind of validation documentation and evidence do you provide?
We provide:
- Validation Procedure
- Validation Plan
- Validation Report
- IQ, OQ and PQ Documentation
Additionally, we are ready to participate whenever your organization is audited or inspected – and present the relevant evidence for our validation activities. SimplerQMS is also, always open for audits. This means will help you get through your audits seamlessly.
Implement robust security controls
SimplerQMS complies with 21 CFR Part 11 password requirements and restricts access to the system only to authorized users with the right access rights. This is achieved through an integration to Microsoft Azure Active Directory (Azure AD) which provides single sign-on, multi-factor authentication, and user data management (usernames, passwords, access levels, etc.).
What customers achieve with SimplerQMS
Utilize proven technology
SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.
Pass audit more easily
Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.
Gain high level of traceability
Gain cross-functional visibility and trace back to the root cause of each nonconformance.
“It’s very flexible, smooth, and easy to use. Documents no longer get lost and the whole history of all products is accessible for anyone at any time.”
Frequently Asked Questions
What is the FDA 21 CFR Part 11?
The FDA 21 CFR Part 11 is a set of rules that specify the requirements for electronic records and electronic signatures under which they are considered trustworthy, reliable, and equivalent to handwritten signatures and paper records.
What is the FDA 21 CFR Part 11 complaint software?
The FDA 21 CFR Part 11 compliant software complies with the US FDA’s requirements for the adoption of electronic records and electronic signatures, under which they are deemed trustworthy, reliable, and equivalent to paper records and handwritten signatures.
Who does 21 CFR Part 11 apply to?
The FDA 21 CFR Part 11 applies to organizations that operate within the medical device, pharmaceutical, and other within FDA-regulated industries that manage electronic records and electronic signatures.
What makes a computerized system FDA 21 CFR Part 11 compliant?
Various requirements have to be met to make a computerized system, like a QMS software or document management system, FDA 21 CFR Part 11 compliant. This includes regular system software validation checks, time-stamped audit trails, operational system checks, security controls, employee training, and most importantly, electronic signatures with the name of the signer, date/time, and the intention of the digital signature.
What are the benefits of 21 CFR Part 11 compliance?
Although the FDA’s 21 CFR Part 11 regulatory framework can be challenging to comply with at first, all the requirements were designed to satisfy the changing needs of life science companies. Also, the Part 11 regulation can help to:
- Increase efficiency within operations
- Lower expenses
- Improve overall system security
- Increase the level of employee training
- Decrease the number of records with defects
Ready to learn more?
To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.
