Build compliance into the way technology is delivered

For Life Sciences organizations, technology changes often come with additional responsibilities.

Systems may support regulated processes, sensitive information or workflows that require clear controls and evidence that they work as intended.

Megnity helps organizations bring validation, governance and compliance considerations into Salesforce, data, AI and integration projects from the beginning.

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Validation · Governance · Compliance — built in from the beginning

How we approach it

Eight ways we build compliance in

  1. Understand what the system is being used for

    The right approach starts with intended use.

    We work with business, technology and quality teams to understand the process being supported, the information involved and the potential impact if something doesn’t work as expected.

    This helps determine where validation and additional controls are required.

  2. Take a risk-based approach

    Not every feature, change or system carries the same level of risk.

    We help teams focus validation effort where it matters most rather than applying the same level of documentation and testing to everything.

    The approach is shaped by the intended use, risk and requirements of the organization.

  3. Build validation into delivery

    Validation becomes harder when it begins after development is complete.

    We consider requirements, traceability, testing and documentation alongside solution design and development.

    This keeps validation connected to the work being delivered and helps business, technology and quality teams stay aligned throughout the project.

  4. Maintain traceability

    Teams need a clear connection between what was required, what was built and how it was tested.

    We help establish traceability across requirements, solution design and testing so organizations have evidence that the relevant functionality has been assessed against its intended use.

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  5. Protect data throughout the process

    Compliance isn’t limited to application functionality.

    Data needs appropriate controls around access, quality, integrity and movement between systems.

    We consider these requirements when designing Salesforce solutions, data platforms, migrations and integrations.

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  6. Bring controls into integrations

    A regulated business process may move through several systems.

    We consider how information moves between platforms, what happens when an integration fails and how relevant transactions can be traced.

    Testing can then look at the complete process rather than only the individual applications involved.

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  7. Approach AI with appropriate oversight

    AI introduces new questions around how information is accessed, generated and used.

    We help organizations define where AI can support a process, what information it can use, what actions it can take and where human review is required.

    For sensitive or regulated workflows, governance and oversight are designed into the use case rather than added later.

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  8. Manage change after go-live

    Validated environments continue to change.

    New requirements, platform updates, integrations and enhancements may all affect the existing solution.

    We help teams assess changes and apply the appropriate testing, documentation and controls so the environment can continue to evolve.

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Across the environment

Support compliance across the technology environment

Our validation and compliance capabilities can support work across the platforms and sources the business already runs on.

The approach depends on the intended use and requirements of the environment.

  • Salesforce
  • Life Sciences
  • Agentforce and AI workflows
  • Data 360
  • Databricks
  • MuleSoft and integrations
  • Data migrations
  • Enterprise applications

How we deliver

From requirements to controlled change

01

Understand

Define the intended use, business process and requirements.
02

Assess

Identify risk and determine the appropriate level of control.
03

Design

Build requirements and validation considerations into the solution.
04

Build

Develop and configure with traceability in mind.
05

Test

Verify the relevant functionality, integrations and data.
06

Document

Maintain the evidence required for the agreed approach.
07

Release

Move the solution into use through the appropriate change process.
08

Maintain

Manage future changes while preserving the required controls.

Where to begin

Working on technology in a regulated environment?

Tell us what you’re building or changing and how the system will be used.

We’ll help you determine how validation and compliance should fit into the delivery.

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