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Quality System and Software Compliance Solutions

Information Technology is now the foundation for meeting regulatory compliance demands.

Historically, the Life Sciences industry has been heavily paper-based with document-centered business processes. The industry is now moving rapidly into Hybrid electronic and document-based business processes. Firms are required to adopt a data-centric approach to maintaining critical data rather than the traditional document-centric approach. The future is moving into a complete digital state, which allows for optimization. This is especially necessary when there is an increased need to reduce costs because of new market conditions.

EngiSystems has developed proprietary solutions to overcome the regulatory challenges in implementing data-centric business processes in an increasing regulatory environment across the globe.

Quality Systems Compliance

Improve the performance of quality management systems in times of economic pressure.  Reduce costs and maintain a competitive edge.

Global Validation Governance

Move from the typical decentralized global validation governance to a centralized strategy to obtain a competitive edge.

Faster, Leaner Compliant CSV Process

Eliminate waste and obtain a 25-30% savings.

Software Validation Managed Services

A data-centric approach is key to overcoming the increasing regulations and need to reduce costs.
The Benefits of An

EngiSystems Partnership

Since 2005, we have focused on creating faster leaner compliance within enterprises.

Our vision is to become the global leader in managed regulatory compliance and engineering solutions that enable Life Science manufacturers to bring safe, high-quality innovations to the market quickly and profitably.

Flexibility and alignment with business objectives.

Optimization and Validation strategy based on risk variables.

Functional Risk Based Testing and Automated Test Strategy.

Case Study – Before
EngiSystems was hired to execute a Global Optimization IT Assessment for the second largest Life Science Company.
We assessed current policies, procedures, and more and worked with 26 teams to identify cost reduction opportunities.
Case Study – After
We identified and prioritized the cost savings while maintaining compliance.
ROI: The strategic roadmap we designed saved more than 25% of the overall CSV cost.

Our Audit Defense Pledge

When a client engages EngiSystems, they are enlisting the software validation industry experts. Our proven processes provide sufficient, objective evidence to demonstrate regulatory compliance. If the regulatory body challenges any of the software validation evidence compiled by EngiSystems during an audit, we stand behind our work and will defend it in support of our client.

We will provide timely, quality response to the regulatory body. All pertinent documentation is readily available and objective evidence is supported. We will explain and support the software validation efforts performed by our team of experts.

The EngiSystems Audit Defense guarantees lower stress, saves time and help maintain organizational focus while minimizing the financial impact of audit findings.