Commercially available software applications such as ERP systems 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.
An important stage in validating a software application from a vendor is to carry out a design qualification (DQ). This consists of a vendor audit which will assess the vendor itself, the business procedures deployed, the quality management system used and the documentation produced.
At BSM our vendor audit services include:
- Validation Plan development
- Design Qualification protocol generation
- Vendor audit questionnaire preparation
- Vendor audit planning and execution
- Vendor audit report production
- Risk Assessment.
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:
- Prior to signing a contract with the preferred software vendor, clients will have a full audit and risk assessment of the vendor and its products in a form which is compliant with regulatory requirements.
- Availability at short notice of qualified and experienced validation engineers.
- Application of best practice methods according to GAMP® and up-to-date industry standards.
Frank Crewe will respond to your query.