Verdad Systems offers software validation services for regulated industries.  Software validation is a requirement of the Quality System regulation. The FDA regulates the phamaceutical industry.

Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer's quality system.

Verdad Systems consultants have years of experience in helping companies achieve FDA validation.  Team members have current active experience with Microsoft Business Solutions Dynamics NAV and GP products and Oracle products. 

Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer's quality system.

The FDA provides guiding principles for the validation of software systems.  The complete guidance is available on the FDA website.  Companies should refer to that guidance as the authoritative language.  See excerpts from that FDA guidance.

Highlights of the principles are as follows:

This guidance provides useful information and recommendations to the following individuals:

• Persons subject to the medical device Quality System regulation
• Persons responsible for the design, development, or production of medical device software
• Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself
• FDA Investigators
• FDA Compliance Officers
• FDA Scientific Reviewers

Good Software Engineering:

• Planning,
• verification,
• testing,
• traceability,
• configuration management

Principles of Validation:

Integration of:

• software life cycle management, and
• risk management activities

Software development should be based on the intended use and the safety risk associated with the software:

• determine the specific approach,
• the combination of techniques to be used, and
• the level of effort to be applied
• validation and verification activities be conducted throughout the entire software life cycle (very important as most failures or device recalls occur from changes)
• the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturer’s intended use.

FDA validation guidance describes user site software validation in terms of installation:

• installation qualification (IQ),
• operational qualification (OQ) and
• performance qualification (PQ)

Verdad Systems Team Members for Validation of Software Systems including interpreting and applying GMP, GLP, GCP and Quality System regulations:

Martin Ramirez - Project Leader has years of experience as an IT manager and leader for business process improvements for all company ERP functions.

Email:  martin.ramirez@verdadsys.com

Glenn Walker - Senior Consultant for FDA validations provides validation and product transfer services for the pharmaceutical, biotechnology and medical device industries. 

Email:  glenn.walker@verdadsys.com

Ben Larson- Senior Consultant for FDA validations has accomplished quality assurance/validation professional and contract project manager with diverse background in pharmaceutical manufacturing, clinical studies and laboratory technology.

Email:  ben.larson@verdadsys.com

Paulette Hamilton - Senior Consultant for FDA validations has fourteen years of success as an Information Technology professional with extensive experience planning, implementing and validating applications in a GMP environment.

Email:  paulette.hamilton@verdadsys.com

Team members can assist clients with the following:

·     Pre-planning of the validation effort (a Validation Plan)

·     Specification of the system’s requirements prior to testing.

·     Traceability from requirements to test cases

·     Justification for any functionality excluded from testing

·     Signatures or initials on executed test cases sufficient to indicate the responsible testers and reviewers.

·     Full disclosure of all errors encountered during testing, the evaluation and remediation of each error and retesting results

·     Management-level summarization of test results with approval signatures of responsible managers

Contact Verdad Systems at info@verdadsys.com