Dedication to quality, personalized support, and the success of your projects are the foundation of Quality Systems Integration in North Reading, MA. Take a look at our service summary and detailed service descriptions.
We develop and implement validation master plans for single and multi-product
We perform impact/risk assessment of systems and equipment per ISPE and ASTM Guidelines; develop and implement commissioning plans and documents to integrate commissioning and startup activities with validation efforts to minimize repeat testing.
We identify critical process parameters, developing and executing process validation protocols for pharmaceutical and biotech manufacturing processes consistent with the FDA January 2011 Guidance for Process Validation, and for Medical Device manufacturing processes per the GHTF 2004 Process Validation Guidance.
We develop and implement cleaning validation master plans and cleaning programs; also develop, execute and summarize IQs and °Qs for CIP and COP systems. Determine Maximum Allowable Carryover (MACO) calculations; develop and execute swab recovery studies to support cleaning validation. Also develop and execute POs for automated and manual cleaning processes and establish dirty and clean hold expiry times.
We develop, execute and summarize POs for moist heat and dry heat component sterilization as well as Sterilize in Place (SIP) cycles for large equipment.
We develop, execute and summarize IQs, °Qs and POs for Direct Impact utility systems such as high purity water systems (WFI, USPW), clean in place systems, clean compressed gases, clean steam, and HVAC/cleanroom systems.
We develop and execute concise reviews of user requirements specifications against design documentation to confirm that proposed designs will, in fact, meet the User Requirements.
We develop, execute and summarize IQs, °Qs and POs for direct impact GMP production equipment such as bioreactors and fermenters, chemical reactors, blenders, tangential flow filtration systems, chromatography systems, Controlled Temperature Units (CTUs), vial fillers and cappers, packaging equipment, parts washers, vial and stopper washers, autoclaves, depyrogenation ovens, lyophilizers and hot melt extrusion equipment.
We develop validation documents such as user requirements specifications, requirements traceability matrices and configuration specifications to integrate with system IQs and °Qs. We also develop, execute and summarize IQs and °Qs for automated systems and spreadsheets based upon the
We develop, execute and summarize periodic validation review and risk based re-validation programs that have minimum impact on production schedules.
We develop, execute and summarize IQs, °Qs and POs for direct product impact laboratory equipment such as incubators, coldrooms, hplcs and microplate readers.
We review existing systems against current regulatory expectations, with practical recommendations to address identified issues and gaps.
We develop and document process risk assessments consistent with ASTM E2500, ICH 09 and GHTF Risk Management guidelines, integrating these risk assessments with validation master plans.
We assist companies with transitioning from GEP to GMP Compliance in coordination with clinical trials and scale-up to commercial manufacturing, including:
We develop and implement VMPs consistent with current risk management approaches for facilities, products, systems and projects.
We assist clients with remediation planning and implementation to resolve issues identified in internal or external audits.
We assist operating companies in reviewing proposed equipment or system changes and assessing impact on process or product quality. We can develop and execute appropriate validation tests to support the changes and document that the changes have been implemented consistent with
Call us today to discuss your Quality, Engineering and/or Validation needs with our