Hood-Burbank Associates, Inc. provides all levels of validation services from high level master plans and strategies to detailed test scripts. We will customize our approach to fit your style and company procedures.




Master Validation Plan

The Master Validation Plan is a tool that provides a company or departmental-wide evaluation of the validation status of all regulated computer applications. The first step in developing the Master Validation Plan is producing an inventory of all regulated applications, including those that have been retired within a certain time frame.

A validation checklist and risk analysis is developed for each system in the inventory. The checklist contains a list of all validation documentation in existence for a system, and lists areas that are missing or inadequate. It provides a quick reference for determining whether all of the necessary validation documentation exists for a system. The risk analysis helps prioritize non-compliant systems so that a departmental plan can be developed for bringing all systems into regulatory compliance.

The Master Validation Plan is instrumental in determining how to best allocate your validation resources.

 



Validation Test Plans and Test Scripts

We can work with your project team to develop a validation test strategy that will meet regulatory requirements for Performance Qualification (PQ). Working with users and system personnel, we can effectively design an overall testing approach and individual test scripts which will address the business needs and requirements of the system.

We have an extensive background in writing test plans, test scripts, and protocols for a variety of systems.

 



Vendor Evaluations

Is your software vendor meeting FDA guidelines for software development? Can they provide you with requested information during an audit? You are responsible for the software you purchase. We can assess vendors' software quality programs and procedures.

We have conducted vendor audits both independently and in conjunction with client staff.

 



Standard Operating Procedures

We can design a complete set of Standard Operating Procedures (SOPs) for your validation program, or develop single topic SOPs to merge with your existing procedures.

Some SOP projects require on-site interviews with client personnel; however, we have completed many of these projects without costly site visits.

 



Retrospective Evaluation

Ensure that valuable information is not lost for systems that were in production before your validation program was begun. We evaluate and organize existing software development life cycle (SDLC) documentation, and if necessary, reverse engineer missing documents.

Many of these systems have more documentation than is realized, but because it may reside in employees' desks, or is not organized according to current standards, it may be overlooked. In one case, we were able to save volumes of important test documentation that was mistakenly earmarked for the company shredder.

 



User Documentation

Document your unique usage of the system so that personnel do not need to wade through endless reams of vendor documentation for the information they need. We can develop custom user documentation for day-to-day reference and to augment your training program.

 



Software Development Documentation

For client-developed systems, we can provide the full range or individual components of software development life cycle (SDLC) documentation. This may include statement of work, feasibility assessment, business needs analysis, user requirements, functional specifications, design specifications, unit test plans, integration test plans, installation qualification plans, operational qualification plans, implementation plans, and other documentation as required by the project.

 



System Retirement

Valuable information can be lost when systems are removed from production. We can organize Software Development Life Cycle (SDLC) documentation for the complete lifespan of the system and develop a strategy for meeting 21 CFR Part 11, Electronic Records; Electronic Signatures.

 


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