Validation Professional Services

Life-Cycle documentation provides objective evidence of design controls, testing and provides an auditable trail of the product development

As you know compliance doesn’t end there.  Effective and timely validation helps to insure that your fully implemented system does what you need it to do, and that it will function correctly, safely and reliably over time.  ValuTrack helps to ensure your fully integrated AIDC system meets its intended use by providing professional validation services as a cost efficient alternative to utilizing in-house resources.  (Validation Process)

Overview

As a key supplier, ValuTrack understands that our products are at the front-end of several building blocks that need to be validated as a completely integrated electronic label management system.  We are well prepared and capable of fully assisting our clients in their regulatory compliance efforts.

This approach assumes that the relevant predicate rules are currently followed and existing computer system validation is maintained.  However, if that is not the case, ValuTrack can provide a broader scope to encompass full computer system validation (CSV) and bring the appropriate resources to bear.

Additionally, validation of any Auto-ID and Labeling software solution in the work environment includes validation to US FDA 21 CFR Part 11.  The Part 11 validation master plan will address those electronic records that are required by industry specific predicate rules that are relevant to your business.

Engagement Model

You will find our professional style and attitude is all about making our clients successful.  We use a “just enough” approach combined with solid methods that meet your objectives and will ultimately be less costly and on-time.  We bring our skills and experience to bear on your problem with a no non-sense hands-on approach that adds value every step of the way.