Mapping GxP controls with cybersecurity frameworks and standards

Part 1:- Mapping GxP Controls with SOC 2 type 2 controls

In the era of diverse cybersecurity control sets, standards and frameworks, it adds up to the overwhelming quotient to consider each control and address separately. This definitely takes a toll on resourcing, effort and costs for the regulated organization. Complexity further increases in a scenario involving a vendor offering an IT application that supports single / multiple domain specific regulated functions e.g. pharmaceutical manufacturing for a regulated customer (pharmaceutical firm, medical device manufacturer). In the absence of mapping the regulated customer might require to re-assess the application, for controls, which might have already been met by the IT vendor by complying to other cybersecurity frameworks and controls. A mapping between cybersecurity controls with GxP controls can help to identify the minimum specifications which need to exist, in order to meet applicable regulatory and/or contractual requirements.

During multiple series of the post, we are going to offer a comprehensive mapping between the GxP controls viz. 21 CFR Part 11, 21 CFR Part 211, 21 CFR Part 820, EU Annex 11, Brazil ANVISA, ISO 13485 with other standards viz. SOC 2 type 2, NIST and guidelines viz. GAMP5. One such instance which can be beneficial for both – IT vendors and regulated customers involves a mapping between a SOC2 type 2 controls and GxP controls. As per our analysis, most of procedural GxP controls and few technical GxP controls for a SaaS / PaaS product are met via the SOC2 type 2 report during vendor assessments.

Advantages of carrying out mapping of GxP controls with other cybersecurity controls

1. Allows regulated organizations to find the similarities in their diverse control sets, standards and regulatory requirements and handle them at once.
2. Will help identify the minimum security requirements that exist to meet applicable regulatory and contractual requirements across frameworks.
3. Can help identify areas of overlap and gaps across the frameworks or requirements a business is trying to follow.
4. Allows companies to harmonize requirements across relevant regulations and standards.
5. For companies getting ready for an audit, mapping controls can help showcase compliance.
6. Businesses can identify gaps across many frameworks, prioritize issues to address those gaps, and track compliance progress.

Majority of procedural GxP controls for a SaaS / PaaS product are met via the SOC 2 type 2 report during vendor assessments

The current version of the mapping involves the GxP controls and SOC 2 type 2 controls. However, we are working on creating an harmonized controls framework to create an end to end traceability of the regulations, guidelines and controls.

Please access the attached document to review the sample mapping between the controls. A complete mapping of the controls can be accessed by registering to our course – Effective GxP Vendor Assessments for IT applications. You can also order a copy of the mapping by reaching out to admin@thegxpcouncil.com