Commercially available software applications are important solutions for most companies in the pharmaceutical, medical device and biotechnology industries. These applications are governed by U.S. regulations (e.g., GMP, GLP and CFR Part 11) and other requirements and guidelines (e.g., GAMP®, MHRA and TGA). To ensure regulatory compliance and reduce business risk, these applications need to be carefully validated. Failure to comply can lead to regulatory citations and costly disruption to business.
BSM specialises in regulatory software testing and validation services, helping clients ensure that key business systems are fully functional and in compliance with applicable regulations. In a regulated environment an important part of business risk management is directly related to a company's computer systems. Our regulatory software validation services include:
- Validation Plan development
- Vendor audit preparation and execution
- User requirements documentation
- CSV protocol generation and execution (i.e. IQ/OQ/PQ)
- CSV training for management and engineers (including customized courses on GAMP® 5, 21 CFR parts 11, 210 and 211 and 820).
- System compliance support (including MVP, SAT/FAT, CSV Report generation, CSV Risk Analyses and validation status maintenance).
BSM employ dedicated engineers all with GMP/FDA environment experience in preparing validation lifecycle documentation, conducting vendor audits, performing systems assessments, and preparing protocols. They also have strong expertise in computer systems implementation (such as ERP, LIMS, MES and EBR systems).
Benefits to clients include:
- Our proven validation approach certifies computer systems in an efficient and secure manner. This means that clients are able to put solutions to work more quickly and realise benefits more quickly
- Availability at short notice of qualified and experienced validation engineers
- Application of best practice methods according to GAMP®, and up-to-date industry standards.
Please click here to find out details about BSM GAMP® training courses.
Frank Crewe will respond to your query.