The challenge
A biotechnology company struggled to keep up with changing regulatory requirements. Managing several computerized systems, maintaining data integrity and keeping validation protocols current all needed expert oversight.
The rules were complex: FDA requirements under 21 CFR Parts 11, 210, 211 and 600, EudraLex Volume 4 and ICH guidelines.
Limited resources affected how thorough and timely assessments and validations were. System and process changes also had to be managed without losing compliance.
Our approach
- SQA Solution provided a Quality Systems and Compliance (QSC) consultant to the client.
- Led assessments, validations and enhancements of computerized systems.
- Ran the data integrity program, including gap and risk assessments and remediation plans.
- Developed and approved SOPs, validation strategies, plans and procedures.
- Reviewed and approved change controls, deviations and CAPAs.
- Served as subject matter expert in meetings, workshops and strategic initiatives.
Results
- Stronger compliance through gap assessments, risk management and consistent validation practices.
- Improved system integrity through stronger validation strategies.
- More efficient quality management, with smoother project implementation and system rollouts.
- Positive stakeholder feedback on proactive compliance management and communication.
- Recommended next steps: regular training on regulatory changes, adequate resourcing for validation, and closer cross-department work on change management.