FDA 21 CFR Part 11 Compliance:
Compliance with U.S. Food and Drug Administration (FDA) 21 CFR Part 11 is important for regulated companies using electronic records and signatures.
With 21 CFR Part 11, the FDA ushered within the use of modernized technology for records and submissions. The regulation made electronic records and signatures as valid as paper records and handwritten signatures. Part 11 doesn’t mandate the utilization of electronic systems. Rather, it specifies the wants for companies that prefer to use digitized systems in their compliance efforts.
What Is 21 CFR Part 11?
21 CFR Part 11 states that electronic records and electronic signatures are treated an equivalent as paper records and handwritten signatures. Regulated companies with any documents or records in electronic format must suits the regulation.
FDA 21 CFR Part 11 Compliance Requirements
Gain a competitive edge with the Master Control Quality Excellence™ solution. Automate and integrate all quality processes. suits 21 CFR Part 11 requirements faster and obtain to plug sooner.
Master Control Documents
Complies with sub parts A, B and C, section 11.3 by providing time-stamped audit trail, reporting and electronic signature capabilities. security measures include dual passwords for document approval. It also has password expiration, encryption and certification. An account lockout prevents unauthorized users from gaining system access.
Master Control Validation Excellence Tool (VxT)
Complies with subpart B, section 11.10 by providing a risk-based approach to testing and software adoption. It drastically cuts down on the testing time and eases the general validation burden, allowing companies to perform an entire validation during a matter of days, or maybe hours.
Master Control Change Control
Complies with subpart B, section 11.10 by automating every step of change control processes, enabing you to realize faster turnaround times. Customizable reports show real-time status of change control tasks and therefore the entire quality system.
Master Control Training
Complies with subpart B, section 11.10 by automating the management of all training processes. Easily route, follow-up and escalate training. Provide online exams, allow group log off and automate sequencing of coaching tasks.
Simplify All Regulatory Processes
21 CFR Part 11 simplifies records management and signature processes by permitting the utilization of digital technology for these quality tasks. FDA-regulated companies will naturally enjoy more speed and better efficiency, which may be achieved with the proper quality management system (QMS).
Achieving Compliance With FDA Predicate Rules
21 CFR Part 11 applies to predicate rules like the present good manufacturing practice (CGMP), good laboratory practice (GLP) and good clinical practice (GCP) regulations. Another rule is that companies must retain certain records for a selected amount of your time . Access to documents must be available upon request. A paperless record management system makes it easier to suits this rule.
How Can MasterControl Help With FDA 21 CFR Part 11 Compliance?
Many of the MasterControl solutions are designed specifically to satisfy the wants of 21 CFR Part 11. they assist you ensure data integrity also as maintain complete and accurate records that are accessible in real time.
What Are The Wants Of 21 CFR 11?
A: 21 CFR 11 requires that closed computer systems must have a set of technological and procedural controls to guard data within the system. Open computer systems must also include controls to make sure that each one records are authentic, incorruptible, and (where applicable) confidential.
What Computer Systems Must Be Compliant With 21 CFR 11?
A: All computer systems which store data which is employed to form Quality decisions or data which can be reported to the FDA must be compliant with 21 CFR 11. In laboratory situations, this includes any laboratory results wont to determine quality, safety, strength, efficacy, or purity.
In clinical environments, this includes all data to be reported as a part of the clinical test wont to determine quality, safety, or efficacy. In manufacturing environments, this includes all decisions associated with product release and merchandise quality.
What Is Computing System Validation?
A: Validation may be a systematic documentation of system requirements, combined with documented testing, demonstrating that the pc system meets the documented requirements. it’s the primary requirement identified in 21 CFR 11 for compliance. Validation requires that the System Owner maintain the gathering of validation documents, including Requirement Specifications and Testing Protocols.
What Is Accurate Record Generation?
A: Accurate record generation means records entered into the system must be completely retrievable without unexpected alteration or unrecorded changes. this is often generally tested by verifying that records entered into the system must be accurately displayed and accurately exported from the system.
What Training Requirements Are Required For 21 CFR 11 Compliant Programs?
A: Users must be documented to possess the education, training, and knowledge to use the pc system. Typically training are often covered by your company training procedures.