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Consulting Services

 
 
Auditing
Quality Systems
Process Validation
Equipment Qualification
Computer Validation
Facility Design/EM
Utility Design/Monitoring
Management Strategies

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GMP Consulting Services

ComplianceNet specializes in helping small, start up pharmaceutical firms establish efficient, cost effective quality systems that will pass inspection and produce high quality products.  We also work with larger firms to review current systems to make them more efficient and robust enough to stand up to current regulatory challenges. 

bulletAuditing: We perform all types GMP and GLP Audits and provide a very detailed, specific report of recommended actions, including full references to the pertinent regulations and guidance documents.

bulletQuality Systems: We can create, review, implement or improve any Quality Systems, including all those for QA, Manufacturing, Laboratories, and support groups.

bulletProcess Validation: We can set up a process validation program that will pass inspector scrutiny, everything from writing the SOPs and Master Plans to writing and executing the protocols and summarizing the data into usable reports.

bulletEquipment Qualification: We can write the qualification protocols on all major pharmaceutical equipment or review your current program to ensure it is current and compliant.

bulletComputer Validation: We can write the SOPs, Master Plans, and protocols required to make sure your systems are fully validated and compliant with 21 CFR Part 11 Electronic Records, Electronic Signatures.

bulletFacility Monitoring: We can review your current Facility Monitoring program to ensure it is robust enough to pass inspection.  We can help you analyze locations that show frequent excursions for how to correct the situation.  We can also analyze data, create trend reports, and write validation protocols.

bulletUtility Monitoring: We can review your current Monitoring programs for water, steam, and plant supplied gases to ensure they are robust enough to pass inspection.  We can help you analyze use points that have had frequent excursions for how to correct the situation.  We can also analyze data, create trend reports, and write validation protocols.

bulletManagement: We can assist with management strategies, especially for small companies that want to set up the most cost effective and efficient compliance team possible with limited resources.

bulletTraining: We can bring training programs to your site and we offer several courses a year at various international sites.

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FDA on 
Systems Based Inspections

Q: Will the investigator tell me whether they are doing full or abbreviated coverage and/or what systems they plan to cover when they start?

A: There is no requirement for the investigator to notify the firm whether the inspection is full or abbreviated OR what systems will be covered.

Robert C. Coleman, FDA
Presentation at PDA
October 2002


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