Compliance services for ISO and
FDA regulations since 1994

Contact Us

Call Tim Stein at 1-408-768-7538

Client Testimonial

BPA worked with us to prepare a facility validation master plan, and to formulate the validation strategy for specific systems. BPA trained our leadership team on how to execute on the validation strategies, and empowered our staff to validate our systems. We value the approach that BPA took because it allowed us to build expertise in-house ensuring we will continuously be successful in our quality programs rather than falling at the next unexpected hurdle.

-COO of a Diagnostics Company

BPA uses a risk-based approach for software validation that meets the FDA's (QSRs), and the EU's requirements (ISO 13485). This approach is consistent with the FDA's guidance documents. We support companies that have to validate the software they use, as well as software development companies that build the applications.

Tim Stein, the Founder of BPA, has written an acclaimed "how to" guide for software validation: The Computer System Risk Management and Validation Life Cycle, Paton Press, 2006, 600 pages. Tim has over 15 years of experience in conducting software validations.

BPA is flexible in providing the services that best meet your needs. Our services include:

Establishing a validation function

We can help you set up a validation capability and plan for achieving compliance with regulatory requirements for software validation. Services include:

  • Software validation need analysis
  • The preparation of a master plan that includes all the items that need to be validated with priorities
  • Procedures for a risk-based approach for software validation, and for software change control
  • IT policies and procedures for infrastructure qualification and change control
  • Training on software validation
  • Auditing of software development vendors, e.g., for cloud computing
  • Managing the influx of new applications and determining if validation is required

To be compliant, you need more than just getting some software validated. You need an on-going capability to manage changes to validated systems and to cope with new applications.

Validation audits and support in addressing audit findings

If you need to audit your software validations, we can perform audits for you, and help you address the findings. Our audits can include:

  • Software validations
  • IT policies and practices
  • Part 11 compliance
  • Vendor cloud-based services
  • Vendor qualification

We will prepare an audit report and recommendations for closing gaps. In addition, we are available to support you in addressing the audit findings.

Knowledge and skill transfer to enable you to perform your own validations

For those organizations that want to save a great deal of money by validating their systems themselves, we will train your employees and help you put in place the policies and procedures that you need. This includes:

  • On-site software validation training
  • Procedures and templates for software validation
  • Support with one validation:
    • Preparation of the validation strategy and plan
    • Feedback on functional and technical requirements
    • Facilitation of risk assessment sessions
    • Feedback on protocols and protocol reports
    • Training on completing protocols
    • Preparation of the validation report

This approach has the following benefits:

  • Your staff will become self sufficient in performing validations
  • You will reduce your work by applying our risk-based approach
  • Your validations will be defensible to regulators
  • The cost of validations will be a fraction of the cost of having consultants perform validations for you
  • You will have the on-going capability to perform your own audits

We can enable you to be self-sufficient in performing software validations.

Performing validations

Having BPA validate your systems has the following benefits:

  • Your validations will be defensible to regulators
  • The cost of the services will be dependent on the level of risk associated with the application. For example, we have established guidelines on the level of testing that is needed based on risk.
  • Your employees will be able to spend their time on other responsibilities

Our risk-based approach will save you time and money.

Consultation on validation projects

This option is designed for companies that have limited dollars for validation and/or want to do most of the work themselves. Our services will be tailored to your needs, your budget, and the expertise level of your staff. Such support could include, for example, deciding on a validation strategy, creating selected deliverables with your staff, or our playing an advisory and review role.

Guidance from BPA and perhaps help in preparing some of the deliverables can have the following benefits:

  • You save money
  • We provide you with the confidence that your validation will be defensible to regulatory bodies
  • We provide the right amount and type of resources you need to work with your staff
  • You stretch your employees' knowledge and experience by our working with them to determine a suitable validation strategy and providing support in areas of weakness

As an expert resource, we provide the precise help you need to get the job done and to be complaint.

Validation procedures and templates

Visit our store to purchase the following documents:

Our procedures and templates provide extensive and detailed instructions and examples so that those new to validation can create the needed documentation.

Validation support for software development companies

We will show you how to integrate software validation into your software development life cycle so that software validation does not require anything beyond good engineering practices.

We also work with developers of software that is in a medical device to help them use compliant software development processes and to create documentation that provides a validation record. See our web page on Medical Device Software Regulatory Compliance and Documentation.

We help you integrating validation into your software development life cycle. Once finished developing a release, your validation will be complete.

Part 11

We will evaluate your applications and procedures for compliance with Part 11, provide recommendations, and assist in implementing the recommendations.

  • Audit for Part 11 compliance
  • Assistance in selecting applications that are Part 11 compliant
  • Recommendations for addressing issues
  • Improvements to procedures and practices to achieve compliance

We will compliment your QA and IT staffs in achieving compliance.

On-site Training
  • "Validation of Applications Used in Production or Quality Systems"
  • "Execution of Validation Protocols"
  • "The Part 11 Regulation"
  • "Part 11 Overview for Software Developers"

For a complete list of BPA training offerings, see Training Programs

BPA Resources
  • BPA's Founder has 17 years of software validation experience and is the author of the acclaimed hands-on guide for software validation, The Computer System Risk Management and Validation Life Cycle, Paton Press, 2006. Tim has given numerous presentations and webinars on the topic.