FDA Compliance

IEC 62304 Compliance

The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices.

The IEC 62304 standard calls out certain cautions on using software, particularly software of unknown pedigree or provenance, called SOUP in the standard. The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.

TechExcel’s DevSuite helps you achieve IEC 62304 compliance though complete tracking history and audit trails. This helps you reduce the costs involved in complying with IEC 62304 regulations while simultaneously increasing end user acceptance and productivity by seamlessly integrating an industry proven solution.

FDA CFR Part 11 Compliance

Manufacturers of pharmaceuticals or medical devices that want to substitute paper records and handwritten signatures with electronic records and electronic signatures must comply with FDA 21 CFR Part 11. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

TechExcel’s DevSuite makes it easy to comply with Part 11 with built in identity verification and compliant electronic signature functions. Don’t waste you time on third party add-ons that may be more trouble than they’re worth. Get the functionality you need fully integrated into your workflows right out of the box.

FDA General Principles of Software Validation

The General Principles of Software Validation recommend a comprehensive software development lifecycle (SDLC) that integrates risk management strategies with principles for software validation. The FDA software validation principles are applicable to medical device software or software used to design, develop, or manufacture medical devices. Devices categorized as class II and III, as well as some class I devices are subject to design controls; of these class the following types of software must be validated for FDA approval:

  • Software used as a component, part, or accessory of a medical device;
  • Software that is itself a medical device (e.g., blood establishment software)
  • Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment);
  • Software used in implementation of the device manufacturer’s quality system (e.g., software that records and maintains the device history record).

TechExcel’s Devsuite accelerates approval by allowing companies to clearly define, document, verify and validate development activities and outcomes against the organization’s process. This of course is not enough; the FDA Software Validation standards prescribe the “Least Burdensome Approach”, an approach that can often give organizations “too much” freedom. Effectively allowing them to, “shoot themselves in the foot”, with their new processes. TechExcel helps you avoid these problems with predefined templates for implementing proven practices that have helped our other customers succeed. This means you can quickly build on the experience and success of others.