At Enhanced Information Solutions
We provide compliance through software validation
This enables our partners to reduce their operational risk and cost which results in successful project delivery every time.
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- GxP Experts
GxP Experts
EIS is fully versed in industry best practices for software validation, such as GAMP5 and FDA Guidance documents
- Software Experience
Software Expertise
With 20+ software partnerships, we deliver unbiased, cost-effective solutions globally, no matter the system
- Comprehensive Approach
Comprehensive Approach
The validation effort must be involved in all aspects of software development, not just documentation and testing
To navigate the complex landscape of software validation, you need a trusted partner
At EIS, we understand the challenges of validating GxP software. Don’t let these obstacles hinder your progress. We can help you avoid:
- Inadequate Documentation
- Lack of User Involvement
- Insufficient Planning
- Over-Reliance on Vendor Assuranes
- Excessive Costs
- Neglecting Risk Management
Validation Approach
One major key to success is involving the validation effort in all aspects of software development, not just documentation and testing. In addition to doing as much as possible to ensure that a software product is bug-free, the software must also do what it is intended to do. Using a broader approach, EIS software validation addresses five key aspects. This fits in with our overall business model because it helps deliver a quality software product, makes sure the customer/end-user is satisfied and ensures a long-term business relationship.
Our validation approach meets all the requirements for:
Functionality
Usability
Reliability
Performance
Supportability
We understand...
that in an FDA-regulated environment such as the life sciences industry, software validation is paramount to compliance. While documentation – and sometimes lots of it – is a standard by-product of a validation effort, the sheer volume of paperwork does not guarantee a fully-validated system.
- EIS has over 30 years of experience on 900+ projects in varying roles. This has provided our staff with the ability to navigate any software development & implementation project through the sometimes difficult validation terrain.
Customers Who Trust EIS
To get started, follow these 3 Steps to Success
Book
Book a Free Consultation at a time that suits you.
Speak
Speak to our professional team who will happily discuss and assess your project requirements.
Agree
Agree on a customized strategy and plan to address your project requirements.
Why choose Enhanced Information Solutions
Choosing the right validation partner can be the difference between a successful project and failing to make it to market.
Key Success Factors
- Create and approve validation strategy
- Leverage vendor testing & documentation
- Focus on business and process relevant tests
- Involve key users in end-to-end testing
- Integrate early with ERP and automation
- Dry runs and informal pre-tests minimize test deviations
- Treat ERBs as data not software if possible
Consulting Services
Industries We Support
- Biotechnology
- Pharmaceutical
- Cell & Gene Therapy
- Medical Device
- Food and Beverage
Our Global Office Locations in The United States Puerto Rico Ireland Germany France Turkey India
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North America & Australia
Enhanced Information Solutions Inc.
1725 Tower Drive, Suite 100 Stillwater, MN 55082
Europe & Africa
EIS Ireland Limited
22 Upper Mount Street
Dublin 2 D02F890 Ireland
Enhanced Information Solutions France
65 rue Jacques-Louis Henon, 69004 LYON
E.I.S. GmbH
Besselstrasse 25
68219 Mannheim, Germany
Latin America
Ave. Innovación solar Núm. 16 Oficina #216, Parque Industrial Oeste Valle Tolima Caguas, Puerto Rico, 00727
India & Asia Pacific
EmIS India Pvt. Ltd
601, Guardian Square, Karve Rd, Erandwane, Pune, Maharashtra 411004
