Services at Quality Systems Integration

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.

Our Services Include:

• Auditing (Internal and Vendor) Experience with GMP/GLP/FDA Regulations
• Metrology/Calibration Program Development and Management Services
• Metrology/Calibration/Re-Calibration Procedures Review and Preparation
• Cleaning Validation
• Equipment Qualification / Validation (IQ – OQ – PQ)
• Final Report Writing
• Process Validation
• Protocol Development (IQ, OQ and PQ) and Execution
• SOP Development
• Support for Presentations to Regulatory Agencies including the FDA (Food & Drug Administration)
• Temperature Mapping Studies Utilizing Kaye and/or Datalogger Technology
• Training Program Development for cGMP Compliance and Management
• Turnover Package Development and Review
• Commissioning
• Validation Master Plan Development
• Validation of Computer Systems, including Automated or Semi-Automated Processes,
  Controlled by a DCS (Distributed Control System), PLC (Programmable Logic Controller), or Similar Computer System
  

More Specifically:

Master Planning

We develop and implement validation master plans for single and multi-product
manufacturing facilities.  

Commissioning

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.

Process Validation

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.

Cleaning Validation

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.

Sterilization Validation

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.

Critical Utility Systems Qualification

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.

Design Qualification

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.

Production Equipment Qualification

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.

Automation (Computer) System Validation

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
GAMP model.

Periodic Validation Review and Re-Validation

We develop, execute and summarize periodic validation review and risk based re-validation programs that have minimum impact on production schedules.

QC Laboratory Equipment

We develop, execute and summarize IQs, °Qs and POs for direct product impact laboratory equipment such as incubators, coldrooms, hplcs and microplate readers.

Compliance Gap Analysis

We review existing systems against current regulatory expectations, with practical recommendations to address identified issues and gaps.

Risk Management

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.

Quality Systems Design and Implementation

We assist companies with transitioning from GEP to GMP Compliance in coordination with clinical trials and scale-up to commercial manufacturing, including: 

• CAPA Systems
• Change Control Systems
• Deviation Procedures
• Equipment and Component Level Impact Assessment
• Periodic Validation Review Programs
• Risk Based Validation Planning and Implementation
• Validation Master Plans

Project Management

Project Planning

We develop and implement VMPs consistent with current risk management approaches for facilities, products, systems and projects.

Owner's Representative: 

• Factory Acceptance Testing and Site Acceptance Testing (FAT/SAT) Development and Execution for New Equipment or Systems
• URS/FRS Development

Validation Maintenance Systems

Remediation Assistance

We assist clients with remediation planning and implementation to resolve issues identified in internal or external audits.

Change Control Support

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
cGMP expectations.  

Give us a Call

Call us today to discuss your Quality, Engineering and/or Validation needs with our
knowledgeable team.