System scope & validation
Identify regulated record workflows, intended system use and available validation evidence with your quality team.
View the regulatory text ↗San Diego life sciences · Readiness assessment
21 CFR Part 11.Start with your records.
A structured review of electronic record and signature workflows, supporting controls and the evidence your team needs to organize.
Mytek Pros helps identify technical gaps and plan next steps alongside your quality, regulatory and system owners.
For biotech, pharmaceutical, medical device and clinical research organizations in San Diego County. Scope depends on the records and systems involved.
- 01Create & change
Map the people, systems and steps involved in generating a record.
- 02Review & sign
Identify authorization, review and electronic signature workflows.
- 03Retain & retrieve
Understand storage, access and record availability over time.
Agree on applicability first
Begin with the regulated workflow.
Part 11 addresses electronic records and signatures within its FDA regulatory scope. An electronic system alone does not establish applicability; the record requirements and actual use matter. FDA’s scope and application guidance provides the starting point for that determination.
Bring quality, regulatory and IT stakeholders together to identify the records, applicable predicate rules and system boundaries before setting the review scope.
Technical controls & supporting evidence
Six areas to bring into the review.
Use these areas to organize an initial discussion. The relevant requirements and depth of testing depend on the agreed scope, system use and applicable FDA guidance.
Access & accountability
Review authorized access, user identity and identification-code/password controls within the agreed system scope.
View the regulatory text ↗Audit trails
Review secure, time-stamped histories of record creation, modification and deletion, including retention and review practices.
View the regulatory text ↗Record retention & retrieval
Examine record protection, retrieval and the ability to produce complete human-readable and electronic copies.
View the regulatory text ↗Electronic signatures
Review signer identity, signature meaning, record linkage and the applicable signature-control requirements.
View the regulatory text ↗Procedures & change control
Review documented operating checks, staff responsibilities, training and controlled system documentation.
View the regulatory text ↗From review to action
Turn findings into an agreed plan.
Map systems & records
Identify intended use, stakeholders, data flows and available documentation for the review.
Document the current state
Review configurations and evidence against the agreed criteria, recording gaps and questions for the quality team.
Prioritize next steps
Define responsibilities, technical improvements and evidence updates. Agree on implementation and verification work separately.
Common planning questions
Before you begin.
Does Part 11 apply to every electronic business record?
No. Start with the applicable FDA recordkeeping requirements and how electronic records are used. FDA’s scope guidance explains that predicate-rule obligations remain relevant and describes its enforcement approach. Your quality and regulatory team should determine applicability.
Is an electronic signature feature enough?
A signature feature is one element of the review. System use, identity, record integrity, documented procedures and supporting evidence also matter. Evaluate the full workflow with the responsible quality team.
Is this a certification or FDA approval?
This service is readiness and technical gap-assessment support. It does not confer FDA approval or a regulatory certification. Findings and remediation priorities are defined within an agreed assessment scope.
What should we bring to the first discussion?
Bring a system list, the types of records involved, intended use, available validation documentation, relevant procedures and a list of responsible stakeholders. Share a summary first; initial inquiries do not require production records or credentials.
San Diego life sciences resources
Prepare your team for the review.
Read our Part 11 readiness guide for San Diego biotech and life sciences →
Let’s define the scope
Discuss your electronic record environment.
Tell us about your industry, systems, record workflows and assessment objectives. Include your quality or regulatory stakeholders and any relevant timeline.
Readiness support and technical remediation planning. Deliverables and assessment boundaries are confirmed in your proposal.
Discuss Your Part 11 Assessment
Share a summary of your systems, record workflows and timing. Fields marked * are required.