• Assistance in developing a quality system that will meet FDA and ISO requirements
• Implementation and validation of computer systems
• Validation services are also provided for facilities, utilities, equipment, and processes
• Support of the development of software imbedded in medical devices
• Support in meeting the European Community directives for medical devices and in vitro diagnostic devices
• On-Site Training

• ISO 13485:2003
• ISO 9001:2000
• Part 11 (Electronic Records; Electronic Signatures)
• ISO 14971 (Risk management)
• Quality System Regulation (medical device GMPs)
• Medical Device Directives (CE Marking for the European Community)
• Current Good Manufacturing Practice for the Manufacture, Processing, Packaging, or Holding of Drugs (cGMPs)
• In Vitro Diagnostics Directive
• Guidelines on General Principles of Process Validation

Assistance in developing a quality system that will meet FDA and ISO requirements

• Managing the implementation
• Conducting a gap analysis
• Developing a plan for becoming compliant
• Helping to design quality systems
• Writing needed documentation
• Implementation and training
• Risk management
• Training on the regulations
• Training internal auditors and/or conducting the internal audit

Implementation and validation of computer systems

BPA uses the RiskVal process that Tim Stein, the founder and CEO of BPA, published in The Computer System Risk Management and Validation Life Cycle, Paton Professional, 2006. His work is the first book to integrate computer system implementation, validation, and the management of risks associated with computer system failure.

• Selecting and implementing an application
• System validation
• Achieving Part 11 compliance
• Evaluating and managing riks associated with system failure
• Providing policy documents, procedures, and templates
• Training on computer system risk management and validation

Validation services are also provided for facilities, utilities, equipment, and processes

• Preparing a validation master plan
• Performing or guiding validations

Support of the development of software embedded in medical devices

• Consulting on the development process
• Performing verifications (testing) and validations
• Preparing the documentation needed to meet design control and 501k submission requirements
• Preparing the technical file

Support in meeting the European Community directives for medical devices and in vitro diagnostic devices

• Selecting a conformity route
• Consulting in meeting the essential requirements
• Preparing a technical file
• Selecting a notified body
• Preparing for a notified body audit
• Self declaring

On-Site Training

• ISO 13485
• Quality System Regulations
• ISO 9001:2000
• Internal Auditing
• Computer System Validation
• Computer System Validation and Risk Management

 

 

 

 

Contact Us
Call Tim Stein at 408-366-0848