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:
Having BPA validate your systems has the following benefits:
Our risk-based approach will save you time and money.
If you need to audit your software validations, we can perform audits for you, and help you address the findings. Our audits can include:
We will prepare an audit report and recommendations for closing gaps. In addition, we are available to support you in addressing the audit findings.
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:
This approach has the following benefits:
We can enable you to be self-sufficient in performing software validations.
We can help you set up a validation capability and plan for achieving compliance with regulatory requirements for software validation. Services include:
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.
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:
As an expert resource, we provide the precise help you need to get the job done and to be complaint.
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.
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.
We will evaluate your applications and procedures for compliance with Part 11, provide recommendations, and assist in implementing the recommendations.
We will compliment your QA and IT staffs in achieving compliance.
For a complete list of BPA training offerings, see Training Programs