Quality Assurance -What are the benefits of Software Quality Assurance ?

Amid 2020, quality assurance leaders in the pharmaceutical, medical device, and other FDA-regulated industries highlighted compliance and production as part of their quality goals. Maintaining consistent compliance has remained part of the top three challenges the industry has been experiencing. How can firms in the life science industry overcome these challenges? Software Quality Assurance is the key industry trend and has many benefits in preventing mistakes to ensure compliance and patient safety.

To summarize, software validation has been a requirement by the FDA since 1997. Software Quality Assurance (SQA) is the set of activities that ensure processes, procedures as well as standards are suitable for the project and implemented correctly

Furthermore, pharmaceutical and medical device companies may be one of the same.

Today, many companies in the industry are still being audited and fined at high costs for similar but different compliant regulated issues.

While it is no surprise compliance tops the list of quality system challenges, resourcing as a close second appears to be an emerging point of focus. Especially given how little comparative attention it garners among industry thought leaders

Below are the top five individually compliant issues for Pharma and Med-Device reported in the last fiscal year of 2020.



Pharma

  1. Responsibilities of the quality unit (21 CFR (Code of Federal Regulations) 211.22)
  2. Written procedures; deviations (21 CFR 211.100)
  3. Testing and release for distribution (21 CFR 21.165)
  4. Production record review (21 CFR 211.192)
  5. Testing and approval or rejection of components, drugs product containers, and closures (21 CFR 211.165) & Stability testing (21 CFR 211.166)

Med-Device

  1. CAPA (21 CFR 820.100)
  2. Design controls (21 CFR 820.30)
  3. Purchasing controls (21 CFR 820.50)
  4. Process validation (21 CFR 820.75)
  5. Complaint files (21 CFR 820.198)



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