The FDA has established, via the issuance of General Principles of Software Validation, far reaching and comprehensive validation requirements relating to all software utilized for “…design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system,” or used to “modify, and maintain electronic records and to manage electronic signatures.”
These guidelines instruct in no uncertain terms that appropriate validation protocols and procedures must be established for software and software changes involved in the above. Unfortunately for the pharmaceutical company or medical device manufacturer, the guidelines leave much of the specifics open to different interpretation, and thus, potentially significant liabilities.
Assigning Appropriate Level of Concern and Risk Assessment
Determining the correct amount of documentation needed or robustness of testing required to ensure FDA compliance when a software change or migration to a new system is made is a critical task, which may be fraught with ambiguity. Though the rationale seems sensible enough, it can be unclear what activities constitute as sufficient validation “confirmed by objective evidence”. For example, software, or specific functionalities of software that affect vital characteristics or functions of the end product needs to be more thoroughly validated and given higher priority than other less critical functionalities.
Will the FDA agree that your validation procedures are adequate if they audit your documentation? An unavoidable degree of subjectivity can make seasoned experts a valuable resource to consider when planning and performing software validation for FDA compliance.
The Threat of a Warning Letter is Real
FDA compliance misgivings in the form of Warning Letters or 483’s have been issued in the past to organizations that were deemed to have: failed to re-validate software after updates or patches, failed to review 3rd party software validation for intended use, or lacked sufficient documentation of validation data.
The inability to address concerns outlined in warning letters or 483’s can risk sanctions and more intense future scrutiny. Inadequate, or incorrect replies to 483’s may result in the FDA issuing a Warning Letter. Read more about the affects of Warning Letters on organizations by clicking here.
Confronting Compliance Challenges
Guidelines require validation of a very broad range of software and their uses with oftentimes ambiguous directives as to how to go about achieving that same software validation for FDA compliance. Outside help may be needed to navigate this issue to avoid the threat of 483’s and Warning Letters, or even other possible sanctions. Confronting these challenges is a necessary and vital part of maintaining a healthy and viable business.
GxP-CC provides compliance consulting to the medical device and pharmaceutical industries. Contact them to discuss the compliance issues now confronting you.