The cost of non-compliance is severe. Rest assured that our experience means a smooth path forward.
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.
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.
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:
Periodic System Reviews
Data and Metadata Workflow Verifications
System Administration Support
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.
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
2. Solution Design
We assess or create the following with your operational needs in mind:
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.