Getting to the root cause of documentation deficiencies.

Inconsistencies in the entire compliance system—
which includes attitudes, expectations, feedback, training, processes, procedures, and forms and templates—are at the root of documentation problems.


Fixing these inconsistencies (not people!) is the way to achieve clear stand-alone documents, including: effective root cause analysis and risk-based CAPA investigations; accurate, well-designed validation protocols and clinical protocols and informed consents; SOPs that precisely describe tasks as
users perform them; technical reports, audits, and clinical study reports that present cogent analysis, rather than raw data; convincing INDs, NDAs, BLAs, and responses to regulatory agencies.

Improving documentation by improving systems is what we do. The payoff is consistency in compliance—and a healthier bottom line.

Please contact us to see how we can benefit you.

 
Medical Writing Training in: - Protocols - Informed Consents (ICDs) - Study Reports (CSRs)
Medical Writing Training in:
  • - Protocols
  • - Informed Consents (ICDs)
  • - Study Reports (CSRs)
Technical Writing & Training in - Investigations, Root Cause Analysis, CAPA - NDAs, BLAs, INDs - SOPs, Batch Records
Technical Writing & Training in:
  • - Investigations, Root Cause Analysis, CAPA
  • - NDAs, BLAs, INDs
  • - SOPs, Batch Records
cGMP and CMC Consulting
  • - Investigation/CAPA System Remediation
  • - Process Mapping and SOP Remediation
  • - CMC, GMP Auditing and GAP Analyses