Companies in the pharmaceutical industry can no longer rely on manual and paper processes to be efficient and compliant. These companies very much rely on technical solutions for their everyday processes. Electronic records and signatures have replaced paper records and manual signatures. Therefore, the integrity, security, and traceability of electronic records and signatures are not optional — they are essential. One federal regulation that provides guidance for these records and signatures is 21 CFR Part 11 (Part 11), issued by the U.S. Food and Drug Administration (FDA). Under Part 11, electronic records and signatures must meet specific standards to be considered as trustworthy and legally binding as their paper counterparts.
For pharmaceutical companies, Contract Manufacturing Organizations (CMOs), and other FDA-regulated industries, a 21 CFR Part 11 assessment is not just a compliance exercise — it’s your recipe for audit success. Whether you’re preparing for your first FDA audit or tightening up your existing quality system, conducting a thorough assessment can identify gaps, reduce risk, and demonstrate your commitment to regulatory excellence.
What is 21 CFR Part 11?
21 CFR Part 11 is part of the Code of Federal Regulations that sets the FDA’s requirements for:
● Electronic records
● Electronic signatures
● Audit trails
● System validations
● Access controls
Essentially, it ensures that companies using computerized systems to create, modify, maintain, or transmit records follow strict protocols that guarantee the records' accuracy, reliability, and confidentiality.
Failure to comply with Part 11 can lead to FDA-issued warning letters, regulatory sanctions, and potentially even product recalls — outcomes no pharmaceutical organization can afford.
Why Conduct a 21 CFR Part 11 Assessment?
An assessment serves as a diagnostic tool to measure how well your organization’s systems, policies, and procedures align with FDA requirements.
Here’s why it matters:
1. Identify Compliance Gaps
Even the most robust IT infrastructure can fall short of regulatory expectations. A detailed assessment reveals gaps such as:
● Missing audit trail features
● Weak user authentication protocols
● Inadequate system validations
● Poor documentation or training records
Identifying these issues proactively allows you to remediate them before they become FDA findings.
2. Demonstrate Due Diligence
The FDA requires transparency and a culture focused on proactive improvement. Showing that your organization has conducted a formal assessment — and taken action — positions you as a responsible and compliant partner.
3. Ensure Data Integrity
Part 11 focuses heavily on data integrity. The assessment ensures that electronic records meet the following criteria:
● Attributable
● Legible
● Contemporaneous
● Original
● Accurate
These attributes are also known as ALCOA principles.
Data integrity is a cornerstone of any successful audit, and a strong assessment validates that your systems support this.
4. Prepare for a Successful Audit
Audit readiness is about more than clean records. It’s about confidence. A well-conducted Part 11 assessment gives your team the peace of mind that all critical systems are compliant and defensible in an audit setting.
What Should be included in a 21 CFR Part 11 Assessment?
An effective assessment should cover both technical and procedural aspects. Key components include:
1. System Inventory
Catalog all computerized systems used for regulated activities. This includes laboratory systems, manufacturing execution systems, quality management systems, and electronic document repositories.
2. Validation Documentation
Review validation protocols, test scripts, and executed results to confirm systems perform as intended and are under change control.
3. Audit Trail Functionality
Ensure all critical actions are recorded in a secure, time-stamped audit trail that cannot be altered.
4. User Access Controls
Verify that role-based permissions are in place and that strong authentication methods are being used.
5. Electronic Signatures
Evaluate how electronic signatures are applied, recorded, and linked to specific records in compliance with Subpart C of Part 11.
6. Standard Operating Procedures(SOPs)
Examine SOPs related to system use, training, access management, and data handling to ensure they reflect actual practice and regulatory expectations.
7. Training and Competency
Confirm that users of electronic systems are properly trained and records of their qualifications are maintained.
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How Often Should Assessments Be Done?
In an organization where quality management is a tightly run process, a 21 CFR Part 11 assessment should be conducted:
● During initial implementation of systems
● Whenever a significant system change occurs
● As part of a regular internal audit cycle (typically annually or biennially)
Frequent assessments not only ensure continuous compliance but also prepare your organization for unannounced FDA inspections.
Slingshot Pharma: Your 21 CFR Part 11-Compliant Solution Partner
While assessments are imperative as part of guaranteeing your compliance status, the foundation of audit readiness is built on the systems you choose to run your operations. Slingshot Pharma is an industry-specific ERP platform designed for pharmaceutical manufacturers and CMOs, with native support for 21 CFR Part 11 compliance baked into its core.
Here's how Slingshot Pharma supports audit success:
✅ Secure, validated system: Built from the ground up to meet FDA requirements for electronic records and signatures.
✅ Traceable communications: Our CMO portal offers compliant, auditable collaboration between partners, reducing the risk of data silos or miscommunication.
✅ Comprehensive audit trails: Every transaction and system change is logged and timestamped — automatically.
✅ User and role management: Robust access controls and electronic signature protocols ensure only authorized personnel can perform and approve critical actions.
✅ Human-readable reports: Records are easily exportable in FDA-inspectable formats, ensuring seamless audits.
Conclusion: Make Compliance a Strategic Advantage
A 21 CFR Part 11 assessment is more than a regulatory checkbox — it’s a powerful tool to identify weaknesses, improve data integrity, and instill operational confidence. Assessing a solution is only a small piece of the puzzle. To truly future-proof your compliance and simplify FDA audits, you need the right systems in place.
Slingshot Pharma is that system. By aligning technology with regulation, it transforms compliance from a burden into a business enabler. With Slingshot, you don’t just survive an FDA audit — you ace it.
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