We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Configuration management (CM) is an important element in systems validation and should be implemented for each individual system as it is being developed, said Scott Hodges, project manager at Stelex-TVG.
FDA-regulated firms waiting for additional guidance from the agency on risk and computer system validation (CSV) might save themselves some time, trouble and money if they apply the proven techniques found in the Good Automated Manufacturing Practice (GAMP) guide, a leading expert said during a recent audioconference sponsored by FDAnews.
The FDA has warned a Florida devicemaker for failing to adequately respond to a Form 483 documenting systematic violations of quality system regulations (QSR) and design controls.
The FDA has issued a detention order for all transcutaneous electrical nerve stimulator (TENS) devices and acupuncture needles shipped by a Canadian repackaging firm cited for failure to maintain adequate quality systems (QS) and medical device reporting (MDR) procedures.
Drugmakers using advanced control technologies for process validation may no longer have to provide multiple conformance batches to FDA investigators prior to distributing a product, the agency said in a recent policy guide.
Avoiding cultural excesses that lead to unnecessary testing and documentation is paramount in conducting an effective validation process, according to regulatory expert and consultant Ray Miller.
Time limits for drugmakers to begin dispute resolution (DR) proceedings with the FDA following facility inspections aren’t long enough and place manufacturers at a disadvantage that is likely to result in incomplete DR requests, PhRMA recently told the agency.