|
Computer System Validations (CSV)
Life Sciences companies operate in a highly regulated environment that is continually growing and evolving as regulations and guidance criteria change. US FDA and EMA require that life science organizations provide documented evidence that their processes, their computer systems, their facilities, equipment, and methods meet quality requirements.
Adding to these pressures are advancements that are introduced by computerized systems and related technologies. Companies have no choice but to significantly invest in achieving compliance across processes and computerized systems while simultaneously continuing to develop new products and maintain profitability.
As the industry looks for ways to streamline validation and reduce the cost of compliance, we at MakroCare Consulting help our clients achieve these goals through its Computer system validation services.
Our services Include:
- 21CFR part 11 assessments and remediation planning
- Regulatory compliance reviews
- Vendor audits
- Validation plans
- System acceptance tests
- Qualification protocols
- Project management
- Development of SOPs
- Training
- IT/IS audits
- Software development
- System design specifications
- System security consulting
Our areas of expertise include:
- Enterprise resource planning (ERP) - SAP, Oracle, JD Edwards
- Programmable logic controllers (PLCs)
- Supervisory control and Data acquisition (SCADA)
- Building management/Automation system (BMS/BAS)
- Process automation/Control systems (PAS/PCS)
- Laboratory information management systems (LIMS)
- Material and resources planning (MRPII)
- Preventive maintenance management systems
- Calibration management systems
- Laboratory data acquisition
- Warehouse automation systems
Our approach lowers the cost of compliance by allowing the development teams to understand compliance requirements from an early stage in the project lifecycle, thus increasing productivity.
|
