Understanding 21 CFR Part 11 Compliance when selecting a new ERP System

Understanding the configuration and implementation intricacies of 21 CFR Part 11 compliance is essential to any software selection process within the Life Sciences Industry. This regulation, also known as FDA's Title 21 Electronic Records and Electronic Signatures (ERES), defines the requirements regulated organizations must meet to ensure electronic records are accurate, consistent, and trustworthy.

So what does this mean when you select a new ERP software solution? To ensure your ERP system can support the infrastructure needed for compliance with 21 CFR Part 11, it must provide complete documentation of process controls, record and data integrity safeguards, accuracy assurances, and user authentication and authorization processes.

Questions to ask your ERP partner on 21 CFR Part 11 Compliance

Ask your ERP partner specific questions about how the system supports compliance with 21 CFR Part 11. Start with Validation. You want to understand how your ERP system supports Validation activities, what documentation they supply, and how upgrades are handled without breaking your Validated state.

Key questions to ask

Validation support and documentation

• What validation documentation do you provide out of the box, such as requirements mapping, test scripts, and evidence templates

• What parts of the solution are pre validated by you, and what parts must be validated by us based on our configuration and business processes

• How do you support validation for updates, patches, and new releases, and what is your recommended approach for regression testing

• Can you provide sample validation deliverables from similar regulated clients, with sensitive details removed

User authentication and account security

• How are users authenticated, and what options exist for multi factor authentication and single sign on

• What are your password policies, lockout rules, and session timeouts, and can we configure them

• How do you prevent shared logins, and how do you handle service accounts or integrations that require access

Access controls and permissions

• How are roles designed and enforced across modules, and can you demonstrate least privilege access in practice

• Can you restrict access by site, department, product line, or transaction type

• How do you handle segregation of duties, and what tools exist to detect or prevent conflicts

• Can you report on who has access to what, and provide an access review report for audits

Electronic records integrity

• How do you ensure records cannot be altered without detection, including attachments and linked records

• What controls prevent unauthorized edits, deletions, or overwrites

• How is system time managed, and how do you ensure timestamps are reliable and consistent across environments

Data integrity and accuracy controls

• What controls exist to enforce complete and accurate data entry, such as required fields, controlled values, and validation rules

• How do you manage corrections, rework, and exceptions so the history remains clear and audit ready

• What checks exist to detect duplicate records, missing values, or out of range entries

• How do integrations protect data integrity when records move between systems

Electronic signatures

• Where are electronic signatures used in the system, and which transactions support signature approval workflows

• What does a signed record show, such as signer name, date and time, and the meaning of the signature like approval or review

• Does signing require re authentication at the moment of signing

• Can you enforce dual approvals when needed

• Can you demonstrate how a signed record is locked and how changes are handled after signing

Audit trails

• What events are captured in the audit trail across the system, including create, change, delete, and approval actions

• Does the audit trail capture before and after values and the reason for change when required

• Who can view audit trails, and can anyone modify them

• How long are audit trail records retained, and can we export them for inspections

Data retention and record retrieval

• What retention options exist for regulated records, including how long data is stored and how it can be archived

• Can the system place records on legal hold or prevent deletion based on record type

• How quickly can you retrieve records, audit trails, and signature history during an inspection

• What reporting or export tools exist for producing audit ready evidence

Security monitoring and incident response

• What logging exists for security events like failed logins, permission changes, and unusual access patterns

• Do you provide alerts or monitoring integrations for security events

• What is your incident response process, and how are customers notified of security events that may affect regulated records

Vendor responsibilities and your responsibilities

• Which controls are managed by the provider and which controls are our responsibility to configure and operate

• What standard operating procedures do you expect customers to have in place to stay compliant, such as access reviews, training, and change control

• Can you provide a clear shared responsibility summary we can include in our compliance documentation

Treat these questions as a qualification gate, not a check the box exercise. An ERP partner should be able to demonstrate how controls work in the exact workflows you will use, not just describe features in general terms. Ask for a guided walkthrough using realistic scenarios such as quality event approvals, batch record review, controlled document release, deviations and CAPA actions, master data changes, and any transaction that requires review and sign off. The goal is to see how records are created, how changes are controlled, how signatures are applied, and how the system proves who did what and when.

Why life sciences companies choose John Hannan LLC

Life sciences teams often need more than a software provider. They need a client-side ERP advocate who can translate regulatory expectations into practical system design, keep decisions grounded in real operations, and protect the program when timelines and budgets get tight.

John Hannan LLC brings deep experience supporting regulated life sciences environments where quality, traceability, and inspection readiness are non-negotiable. We help teams define clear requirements, pressure test vendors and implementation partners, and align workflows across quality, operations, IT, and finance so the solution fits the business and holds up under audit.

We also help architect and manage 21 CFR Part 11 controls across most major ERP platforms, including electronic signatures, audit trails, access controls, and data integrity safeguards. The focus is simple. Build a defensible path to a Validated state, maintain it through upgrades, and reduce reliance on manual workarounds that increase risk over time. Contact us today to learn how we can help you with 21 CRF Part 11.