The cost of non-compliance is severe. Rest assured that our experience means a smooth path forward.

Expertise that

ANSA takes a risk-based approach to compliance validation by analyzing policies, workflows, Standard Operating Procedures (SOPs), and regulatory guidelines to build an optimized verification and qualification process.

We own the complexities of the compliance process so you don’t have to.

Employees sitting around a table for a compliance management meeting

Compliance Management + Industry Experience

Our team is composed of industry professionals within the pharmaceutical, biotech, and medical device industries who truly understand the role of compliance management in your daily operations. We have an extensive track record in building laboratory and manufacturing processes necessary for a 21 CFR Part 11 compliant system.

Whether you are updating an existing validation process or building one from the ground up, we know what it takes to satisfy regulatory requirements and keep your institution safe and cutting-edge.

The Compliance Management Process

The validation process consists of 5-6 phases tailored to our client’s needs.

graphic depicting the compliance management process

Streamlined Compliance Solutions

Compliance is a living mechanism that requires upkeep throughout the life of a system. At ANSA, we keep our clients up to date with:

compliance system reviews

Periodic System Reviews

data management

Data and Metadata Workflow Verifications

administrative support for compliance management

System Administration Support

user traceability for compliance management

User Traceability

Connect with the resources you need to keep your laboratory and manufacturing operations in compliance so that you can focus on the work that drives your bottom line.

Scientists in a lab talking about validation planning

1. Validation Planning

We take the following steps to chart an optimized course of action:

  • GxP Assessment: Used to determine If validation Is necessary
  • System Categorization: Current Good Automatic Manufacturing Practices (GAMP) 5 requirements consist of 4 categories:
    • Category 1: Infrastructure / Operating System
    • Category 3: Non-Configured (Out-of-the-Box) Systems
    • Category 4: Configured Systems
    • Category 5: Custom Applications / Systems
  • Risk Assessments
  • User Specification Requirements (URS)
  • Gap Assessments
  • Validation Plan / Master Plan

Our experience means a smooth path forward.

2. Solution Design

We assess or create the following with your operational needs in mind:

Woman looking through microscope for compliance solutions

Data Integrity + Remediation

There is no overstating how critical compliant data and Information Technology (IT) strategies are. The right tools and the right team are needed.

Beyond compliance, this is also what feeds company growth. Proper data management allows for intelligent scaling.

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