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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 have reams of documentation written about it and then spend countless hours executing those documents.

We use an efficient systematic, risk based, quality system approach 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 we 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
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News, Events, Validation Master Plans, IQ, OQ, PQ, 21 CFR Part 11 gap analysis, Summary Reports, CSV, GXP, GMP, cGMP, GAMP4, SOP’s, URS, FRS, URS and DDS Generation for all packaging and processing equipment
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