SMB Validation & Compliance Group Inc. “Our ‘trademark’ is our understanding that ‘Validation is a Regulatory Requirement within a Business Environment, not a Science in itself.’ We understand that Pharmaceutical and Medical Device manufacturers purchase equipment in order to run production, not to receive reams of documentation and then spend countless hours executing those documents.

We use an efficient, systematic, risk based, quality procedure to developing protocols. We also employ a common sense, pragmatic approach to protocol execution which allows us to fulfill all regulatory documentation requirements efficiently and with a minimum of delay and with a minimum of interference with our customers’ operations.

We have worked with all the major equipment suppliers to the pharmaceutical industry and have developed solid relationships with these manufacturers in order to quickly obtain the information required to develop protocols for their machinery.

We are experienced validation professionals, providing flexible practical solutions. We have knowledgeable, dedicated staff. We maintain strong relationships with equipment suppliers promoting improved project performance.

• Auditing Services
• 21 CFR Part 11 gap analysis
• Quality Plans
• Validation Master Plans
• IQ, OQ, PQ Protocol
  Generation & Implementation

• Summary Reports
• Computer System Validation
• GAMP5
• Project Management
• SAT/FAT Generation & Implementation

• SOP Development & Review
• Equipment/Process Specification
• URS Generation
• FRS Generation
• DDS Generation

SMB Validation & Compliance Group Inc. has a extensive expertise in:

• The Pharmaceutical, Medical Devices and Biotech Industries
• Equipment Design and Construction
• Validation Master Plans
• cGMP Training
• GAMP 5 documentation
• Qualification documentation and implementation
• Developing Standard Operating Procedures
• Development of User Requirement Specifications (URS)
• Detailed Design Specifications (DDS)
• Factory Acceptance Tests
• Site Acceptance Tests
• Pharmaceutical production and packaging
• Pharmaceutical production environment and physical facilities
• Operator and Maintenance personnel training
• Project Management
• Quality auditing

This experience provides a competitive advantage over other validation providers. Few equipment suppliers employ personnel that offer the training and experience of the SMB Validation & Compliance Group Inc. On the other hand, few professional providers can profess to possess an equally in-depth knowledge of equipment design and assembly as SMB does. Therein lies the competitive edge; SMB Validation & Compliance Group Inc. offers a wider range of services than the competition along with significant practical “hands on” experience both from our customers’ perspective as well as that of the regulatory agencies.