Optimum Quality - Life Science Support

Computerised System Validation Consultancy

At Optimum Quality, we focus on paperless validation of computerised systems (CSV), according to ISPE’s GAMP^® 5 Second Edition, data driven, with requirements management in the center. Our validations are highly effective, efficient and sustainable, reducing the effort by 50% or more.

We also provide services regarding Quality Management Systems and Quality Procedures.

We provide the support you need to enable you to focus on your core business.

We seek the balance between what you want to do yourself, and what you want us to do for you.

Together we find the optimum

We provide services that are:

Cloud based
Paperless
Data driven
State-of-the-art
Sustainable

We apply:

GAMP^®5 Second Edition
Risk Management
Critical Thinking
Computer Software Assurance
Requirements Management

We use tooling that:

Enables validation of agile development
Supports integrated testing
Supports automated testing
Makes validations highly effective and highly efficient

What we offer, is our core business. This has our passion and we strive for the best.

But we would fully understand that what we love, for your company might more be perceived as of secondary importance. Something that not necessarily needs to be at the highest level. We can guide you in the level you really need, and ensure that you receive a service that is fit for purpose and cost effective.

Together we find the optimum

What we do

Our main focus is on paperless validation of computerised systems (CSV), according to ISPE’s GAMP® 5 Second Edition. We use Microsoft Azure DevOps and Modern Requirements for DevOps.

We validate and qualify fully Risk Based. We apply Computer Software Assurance and Critical Thinking. We work 100% paperless. We have moved from document-based to record-based, and from system related requirements documents to data driven integral requirements management (meaning: definitely not a paper-to-glass solution). This ensures elimination of contradictory requirements.

This makes revalidation or validating many systems extremely efficient. This makes our validations highly effective, efficient and sustainable, reducing the effort by 50% or more.

We also provide services regarding Quality Management Systems and Quality Procedures, like for System Development Life Cycle (SDLC) Management, Application Management, Incident, Problem, Change and Deviation Management, Continuity Management and Security Management.

We do this primarily for the Life Science Industry.

We can completely take over your validation effort. You can do the validation yourself and use us as your sparring partner. Or we could arrange a hybrid cooperation. We send you all final documents, and store your data for 10 years. Or we help you implement your own environment and we support you in working with it.

Together we find the optimum

Who are you

We could imagine that you are someone who is looking for a highly effective and efficient validation of one or more computerized systems. Maybe a company who would like to begin with outsourcing validations, but in the future would like to validate themselves.

Someone who would really like to renew his/her Computerised System Validation (CSV) approach.

A company that seeks the state-of-the-art validation of computerised systems, paperless, data driven, requirements based.

We look forward to hearing from you for any relevant matter.