Managing Data Integrity and Part 11 Compliance for Device Suppliers Do It Right or Get a Warning Letter

Held Jan. 31, 2012

Devicemakers — Recent warning letters point to increased focus on ensuring that your suppliers are delivering validated data and software.

How do you really know if the data and software from your suppliers is actually validated and meets FDA requirements?

The FDA is focusing on the handoff of data and software from suppliers to device manufacturers.  Check out some recent warning letter findings:

  • “Your CAPA investigation failed to evaluate OEM validation review processes…specifically evaluation of software….” (2011)
  • “Your firm failed to assess the failures of [the supplier’s] quality system…including an upgrade of the instrument software.” (2011)
  • “Failure to establish and maintain adequate procedures for validating the device design, including software…. The software used in the microprocessor boards [provided by a supplier] … has not been validated. You [and the supplier] were unable to determine how many software revisions had been released for [your device] and what changes were made during each revision.” (2010)

Validation takes time and money and, by the time FDA flags you or your supplier for unreliable data, it may be too late.  Fortunately, help is around the corner.

On Jan. 31, 2012, FDAnews hosted a special training session on data integrity and Part 11 compliance, conducted by the expert many in the device regulation community respect as ‘the best in the business’ — author, speaker and consultant John Avellanet.

Mr. Avellanet runs a crash course on improving data integrity. In 90 whirlwind minutes, you’ll learn practical, easy-to-use information that converts Warning Letter cautions, FDA official statements and investigator questions into real-world processes and valuable benefits. Here’s just some of what you’ll discover:

  • The types of supplier-provided 510(k) submission data the FDA reviews under its Application Integrity Policy
  • Sampling methods the FDA will accept when reviewing supplier-provided data
  • Elements of computer validation protocols the FDA will accept
  • SOPs that ensure proper supplier oversight when it comes to Part 11
  • Red flags that signal when a supplier’s data integrity is failing
  • Records to retain that show FDA your supplier Part 11 oversight meets agency expectations
  • How to maximize control and compliance in light of the growing interrelationship between 21 CFR Parts 11 and 820
  • FDA concerns regarding oversight of suppliers’ computer validation activities
  • Tips when planning to outsource device production and/or clinical testing
  • And much more

Every listener receives two SPECIAL BONUSES at no additional charge:

  • Checklist of specific Part 11 control points to answer when qualifying a supplier
  • Checklist of elements needed in a supplier’s computer validation plan

The rules on Part 11 compliance are evolving. You stay current or risk the consequences — from fines and penalties, to nasty product liability situations. Don’t take those risks — not when it’s so easy and practical to get up to speed. Grab this chance to get the training you and your staff need. Order now.

Spread the word throughout your organization. Make particularly certain to notify the following key staff :

  • QA personnel
  • Regulatory affairs professionals
  • Validation engineers
  • Quality auditors
  • Supplier qualification teams
  • IT audit teams
  • Staff responsible for 21 CFR 820.50 purchasing controls compliance

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

John Avellanet, Managing Director of Cerulean Associates LLC and a former C-level biopharmaceutical executive, provides practical, business-savvy solutions to strengthen compliance. His book Get to Market Now! is a BIO 2011-featured title. As a consultant, he assists FDA-regulated companies of all sizes in solving Part 11 and data integrity issues and streamlining quality systems. Mr. Avellanet was personally trained by the authors of 21 CFR 11 to conduct FDA inspections, and has himself trained FDA and Health Canada officials. He is a frequent speaker at industry conferences and organizations around the world. For more information, visit Mr. Avellanet’s website at or email specific questions about this webinar to

Order now!