Validating Third-Party Software: Avoid the Common Pitfalls of Vendor-Supplied Tools

Held March 25, 2009

As drug and device companies continue to outsource functions to cut costs and increase productivity, the software industry is stepping up to the plate. In fact, most offer an add-on package they say will help integrate their product into a client’s validation effort.

But don’t just rely on vendors’ claims. As drug and device firms have already discovered the hard way:

  • Traceability — What if a traceability matrix is not part of the package? How will you determine what the provided testing protocols cover? What do they leave out?
  • Failure to meet internal quality standards — Maybe the validation package is pretty good. But will it comply with your standards and will the documentation fit your internally defined formats?
  • Hidden costs — Is everything that the salesperson told you should be in the package actually in the package?

All of this can be avoided by understanding the risks inherent in vendor-supplied validation packages — and asking the right questions — before making the purchase.

Software validation expert Carlos Morgado tells you what you need to know before purchasing validation packages, how to reduce the common risks associated with them and tips on incorporating them into their in-house validation master plans.

Order now for your entire team to listen in and discover:

  • What questions to ask a prospective software supplier to ensure they define validation the same way you do
  • Ways to determine the quality of the validation package documentation before making a purchasing decision — do they match the requirements of your QA department?
  • The common risks associated with vendor-supplied validation packages and how to reduce them by knowing ahead of time what you may have to change
  • The types of testing, such as the traceability matrix, that suppliers typically do not include in their test protocols
  • Compliance considerations when using a vendor-supplied validation package — how can you be sure you’re applying proper validation methodology?

Ensure the validation tools supplied by outside vendors will meet the FDA’s and your internal standards and allow you to seamlessly integrate with your in-house validation efforts.

This audio CD/Transcript is a must for drug, biologic and device firm employees responsible for ensuring the integrity of validation efforts, including:
  • Site managers and operations managers
  • IT managers
  • Compliance and quality managers
  • Auditors
  • Clinical QA/QC specialists
  • Compliance officers
  • QA/QC personnel
  • Validation specialists, scientists and engineers
  • Regulatory affairs professionals
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Carlos Morgado is an associate director with CSI Validation and Compliance Services. He has over 20 years of software quality assurance-related experience, of which 14 are in an FDA-regulated environment. In his role at CSI, Carlos is responsible for providing FDA-regulated companies with compliance and validation consulting services. He has provided clients with strategic and tactical services associated with, but not limited to, implementation of QA systems to support IS/IT operations in an FDA-regulated environment, network/infrastructure qualification, validation of Adverse Event Reporting Systems, LIMS, Data Acquisition and Accessioning System, SAS, various 21 CFR Part 11 inventory (including assessments and remediation activities) and other ERP system validations.

Carlos joined CSI in December 2003. Prior to CSI,  he was a senior manager in charge of the North East IT Compliance Services group. He managed and executed compliance and validation projects on a variety of different computerized systems. Specific project responsibilities included, but were not limited to: validation project planning and management, document QA, preparation of system specifications, qualification test protocols, development of standard operating procedures, on-site testing, data analysis, preparation of final reports, 21 CFR Part 11 compliance assessments, contingency and remediation planning. Carlos has also performed numerous audits of software suppliers on behalf of clients. He is a frequent speaker at FDA regulatory conferences on various topics that apply to compliance and validation.

Order now!