21 CFR Part 11 Compliance and Software Validation Services
Protect the Integrity of Your Electronic Records
REJIMUS helps companies evaluate, validate, document, and maintain computerized systems subject to 21 CFR Part 11—the FDA regulation governing applicable electronic records, electronic signatures, and handwritten signatures executed to electronic records.
Our Part 11 services help ensure that covered systems are validated for their intended use and supported by the controls, procedures, documentation, and training necessary to produce electronic records that are accurate, reliable, secure, retrievable, and inspection-ready.
Designed specifically for the Food and Beverage, Dietary Supplement, Cosmetic, and over-the-counter (OTC) drug industries, our approach connects Part 11 compliance with the FDA predicate-rule requirements and cGMP Quality Systems already governing your operations.
What Is 21 CFR Part 11?
21 CFR Part 11 establishes the criteria under which FDA considers certain electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
Part 11 may apply when a company:
• Maintains records electronically that are required by FDA regulations
• Relies on electronic records to perform regulated activities
• Submits designated records to FDA electronically
• Uses electronic signatures as the equivalent of required handwritten signatures or initials
Part 11 works together with the underlying FDA requirements—commonly called predicate rules—that require a record to be created, reviewed, approved, retained, or submitted.
Depending on the product and operation, those predicate requirements may include regulations applicable to food, dietary supplement, cosmetic, or OTC drug manufacturing and quality operations.
Part 11 Applicability Is System and Record Specific
Not every computer system or electronic record used by an FDA-regulated company is automatically subject to Part 11.
The determination depends on:
• The type of record being created or maintained
• Whether an FDA regulation requires the record
• Whether the company relies on the electronic or paper version
• How the system is used within the regulated process
• Whether electronic signatures replace required handwritten signatures
• The system’s potential effect on product quality, consumer safety, and record integrity
REJIMUS begins each engagement by identifying applicable predicate rules, regulated electronic records, system functions, electronic signatures, and operational risks. This documented assessment establishes a defensible validation scope while avoiding unnecessary testing and controls.
What Is Part 11 Software Validation?
Part 11 software validation is the documented process of establishing objective evidence that a computerized system consistently performs according to its approved specifications and intended use.
Validation does not end with confirming that the software’s features operate. It evaluates the system as it is configured, controlled, and used within your organization.
A Part 11 validation program may evaluate:
• System accuracy and reliability
• Consistent intended performance
• User requirements and regulated workflows
• Access and authority controls
• Electronic-signature controls
• Secure, computer-generated audit trails
• Data creation, modification, review, and approval
• Record protection and retention
• Accurate and complete record retrieval
• Backup and restoration
• System interfaces and data transfers
• Change control
• System documentation
• Personnel qualifications and training
The extent of validation should be supported by a documented risk assessment addressing the system’s intended use and potential effect on product quality, consumer safety, regulatory compliance, and data integrity.
REJIMUS Part 11 Services
Our services include:
• Part 11 applicability assessments
• Electronic-record and electronic-signature assessments
• Part 11 gap analyses
• Computerized system inventories
• System and data-integrity risk assessments
• Validation planning and strategy
• User and functional requirements development
• Software supplier assessments
• Configuration and security reviews
• Audit-trail assessments and testing
• Electronic-signature assessments and testing
• Test-protocol and test-script development
• IQ, OQ, PQ, and user-acceptance testing, as applicable
• Requirements traceability
• Deviation investigation and resolution
• Validation Summary Reports
• Existing-system remediation
• Data-migration validation
• Part 11 SOP development
• Personnel training
• Change-control and revalidation assessments
• Periodic system reviews
• Ongoing validation lifecycle support
Part 11 Expertise Integrated With Your Quality System
Part 11 compliance cannot be achieved through software features alone.
A compliant operating environment also depends on documented procedures, qualified personnel, controlled system access, appropriate electronic-record practices, management oversight, and effective change control.
REJIMUS integrates Part 11 validation with our established regulatory and quality capabilities, including:
• Quality System design and optimization
• SOP and controlled-document development
• cGMP facility and supplier auditing
• FDA inspection preparation
• Form 483 and Warning Letter response
• Compliance remediation
• Quality Assurance and Quality Control support
• Regulatory due diligence
• Personnel training
This integrated approach helps ensure that your electronic systems support—and remain aligned with—the Quality System governing your regulated operations.
Led by More Than 30 Years of Experience
REJIMUS’s Part 11 Software Validation Services are led by a professional with more than 30 years of experience in computerized systems, validation, quality, and regulated operations.
That specialized expertise is combined with REJIMUS’s practical knowledge of the Food and Beverage, Dietary Supplement, Cosmetic, and OTC industries.
The result is a risk-based validation program designed around your actual systems, electronic records, regulatory responsibilities, and business operations.
Build a Defensible Part 11 Compliance Program
Whether you are implementing a new system, evaluating an existing platform, preparing for an FDA inspection, responding to an audit observation, or managing a significant software change, REJIMUS can help establish the documented evidence and operational controls needed to support Part 11 compliance.
Protect your electronic records. Strengthen your Quality System. Demonstrate that your regulated systems perform as intended.