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IQ/OQ/PQ / PV Validation Details
As your regulatory compliance partner, we assist you in determining the scope of your regulatory needs,
steer you through the appropriate levels of compliance, and design a solid strategy for future regulatory compliance objectives.
Phase I: Regulatory Compliance Assessment
 We
examine and inspect laboratory guidelines; perform system and equipment reviews, and
assist you through QA audits (pre-FDA inspections). We also provide compliance reviews and services for QC, manufacturing, and operations. Specifics include:
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Quality Programs (QA/QC) |
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Documentation management |
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Procedures and policies (SOPs) |
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Compliance training for personnel |
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Quality Control Testing |
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Failure investigation |
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Change Control |
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Method validation |
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Equipment validation/qualification |
Phase II: Regulatory Compliance Development
 We
assist you in creating, modifying or enhancing the effectiveness of your Quality Programs. Through consultation we address:
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Quality assurance/control development |
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Conformity/compliance planning |
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Regulatory compliance documentation |
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Remedial\corrective action plans (failures, 483 responses) |
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Project planning |
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IQ OQ PQ validation (EPA’s
CROMERRR; FDA’s CFR 21 Part 11; equipment IQ OQ PQ) |
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Clean room validation and qualification |
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Phase III: Regulatory Compliance Implementation
 We
assist you in executing the specifics of your compliance programs, including:
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Achieving GMP/GLP status and accreditation |
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QQ/QC audit reviews |
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Laboratory and manufacturing processes |
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Remedial/corrective action plans (System failures and 483 responses) |
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GMP/GLP training |
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Execution of validation protocols, change control, and SOPs.
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Steering you through
the appropriate levels of compliance for your company. |
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