Life Sciences: FDA 21 CFR Part 11 Compliance

Life Sciences: FDA 21 CFR Part 11 Compliance

In the Healthcare and Life Sciences, Pharmaceutical and Medical Device products and services directly impact consumer health and safety and must be able to prove compliance with the United States Food and Drug Administration (FDA) strict guidelines.

The following is how DocuSign helps with CFR Part 11 Compliance. One of the challenges of Life Sciences professionals is integrating the right level of signature compliance with their ITSM Systems. Servicenow for example integrates with DocuSign to control access, records management, and integration.

The FDA 21 CFR Part 11 regulations that apply to medical device and pharmaceutical manufacturers for proving digital compliant governance around handling electronic records and electronic signatures for electronic records (including electronic batch records and device history records) for collecting, maintaining and associating electronic signatures, with compliance activities trust to the same degree as signatures on paper documents.

The heart of the matter is that FDA 21, CFR, Part 11 is code designed to ensure Healthcare and Life Sciences service organizations are developing and implementing the right level of documentation for developing and implementing records of what was done where, in what system, who approved it, and maintaining a digital standard such that electronic signatures, the audits, and the digital records that contain them are as equal or more accurate, trustworthy, confidential, trustworthy, and reliable as their hard copy manual counterparts.

FDA 21, CFR Part 11 Scope of 3 Control Requirements

An example of how this looks at a high level would include these 3 control requirements:

For all records created, FDA is generally looking for control compliance:

  • The system was operational before the effective date.
  • The system met all applicable predicate rule requirements before the effective date.
  • The system currently meets all applicable predicate rule requirements.
  • The system contains documented evidence and justification that the system is fit for intended use

How to set up DocuSign with ServiceNow

IT Service Management Change Management Process is at the heart of compliant introduction effective date, and managed evidence of compliance with all digital change management Part 11 Compliance Here is how ServiceNow uses DocuSign for example to set up this capability.

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