CSV & Part 11 Compliance

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FDA and EMA Electronic Data Integrity

The Food and Drug Administration (FDA) requires life science companies to have controls on systems utilized to manage electronic data and records.  These systems of hardware, software, and IT networking can be very complex and are sometimes not under Quality Assurance (QA) change management. The goal of 21 CFR Part 11 is to ensure that each of your systems are secure, recoverable, validated, properly maintained, and that any electronic signatures produced are genuine.

Implementation of Part 11 allows a company greatly increase the efficiency of individuals, reduce errors by identifying risks, and increase overall productivity of the company. Part 11 also allows any paper record to be replaced by an electronic record, and allows any handwritten signature to be replaced with an electronic signature.

Although Part 11 is an essential law, there has been much misunderstanding about it. The law is less than three pages long and doesn’t give a lot of detail about electronic records and signatures or the validation thereof. With our risk-based approach, your company can quickly become FDA 21 CFR Part 11 compliant all types of electronic records and signatures.

Similarly, Europe’s EMA has the analogous Annex 11 statute that does differ from Part 11.  Kymanox subject matter experts know how each rule is inspected, reviewed, and enforced – and can help guide your organization accordingly.

We use a best-in-class CSV/Part 11 toolkit, which includes a very effective and extensive Part 11 checklist.  Where electronic controls cannot be utilized reliability to meet compliance mandates, Kymanox knows how to augment systems with procedural controls and training to meet all regulatory body expectations and also de-risk the business.

There are four primary areas of 21 CFR Part 11 compliance:

  1. Standard Operating Procedures (SOPs) – If you are starting from scratch, you will need SOPs to address the IT infrastructure. They address Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures.
  2. System Features – We can help you ensure the computer systems are secure, contain audit trails for data, and ensure the integrity of electronic signatures.
  3. Software as a Service (SaaS) – If you are searching for SaaS hosted platforms for uses in document control or business management, Kymanox can identify industry leading software, assist in qualification, or develop your SaaS infrastructure.
  4. Computer System Validation (CSV) – Every computer system must have documented evidence that the system does what is intended and that users of the system can detect when the system is not working as intended. Kymanox uses a risk-based approach to CSV as the most efficient and cost effective method of validation.

Additionally, Kymanox can provide the following Part 11/Annex 11 related services such as:

  1. Gap assessments of the software, infrastructure, and IT services your business relies on, whether at your premises or off-site at a vendor facility.
  2. If appropriate, we also assess other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, and problem reporting.
  3. 3rd-party supplier audits to evaluate the capabilities and quality systems of a prospective vendor.
  4. Response audits when there are concerns with the performance of a purchased product.
  5. Computer System Validation.

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KymanoxWORKS offers Computer System Validation toolkits for Pharma/Biotech and Medical Devices.

For more information, please view the packages at our store.  


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