APS Compliance Consultants Inc. known also as "Access Pharma Solutions" is a Quebec consulting firm for Pharmaceutical and Food industries.
Our goal is to provide accessible consulting services to our clients by tailoring our services to their business needs and constrains.
Our target is to address our clients requirements with well thought practical and low maintenance solutions by accurately assessing their needs, educating the end users and implicating them in solution development.
Proactively contributing to our client's success is the main key to our growth.
A.P.S has a large knowledge of Canadian, American and European pharmaceutical and Food good practices, standards and regulatory requirements such as: CGMP, ICH, FDA 21CFR Part 11, USP, EP, BP pharmacopeia and GAMP guidelines.
A.P.S. Provide consulting and execution services in the following fields during the life cycle of the laboratory equipment/ systems to ensure compliance to CGMP guidelines, USP <1058> and other regulatory requirements.
A.P.S. Provide consulting and execution services in the following fields during the life cycle of the laboratory equipment/ systems to ensure compliance to CGMP guidelines, USP <1058> and other regulatory requirements.
A.P.S. Provide consulting and execution services in the following fields during the life cycle of the laboratory equipment/ systems to ensure compliance to CGMP guidelines, USP <1058> and other regulatory requirements.
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Equipment/System selection process.
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Determination of qualification requirements and activities.
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Preparation and execution of qualification protocols (IQ, OQ, PQ).
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Utilization SOP redaction and staff training.
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Determination of frequency and content of the PM and periodic qualification programs.
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Managing the PM and Qualification programs.
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Troubleshooting and repair.
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Equipment / System decommissioning and retirement.
A.P.S. provides the following supports to its clients during the life cycle of their complex and / or off the shelf computer systems, from conception to their retirement.
Using GAMP risk-based approach, we ensure the compliance to cGMP guidelines, FDA 21CFR Part 11 and other regulatory requirements.
A.P.S. provides the following supports to its clients during the life cycle of their complex and / or off the shelf computer systems, from conception to their retirement.
Using GAMP risk-based approach, we ensure the compliance to cGMP guidelines, FDA 21CFR Part 11 and other regulatory requirements.
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Project management
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Requirement analysis
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Configuration and design including USM
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Risk assessment and Test Script writing
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Preparing validation documents (URS, FRS, DS, IQ,OQ, PQ)
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Redacting relevant SOPs and staff Training.
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System Periodic Review
A.P.S. Support its clients to ensure their processes comply to the current industry and regulatory requirements and stream lined for the optimum performance. our services include consulting and execution of the following activities.
A.P.S. Support its clients to ensure their processes comply to the current industry and regulatory requirements and stream lined for the optimum performance. our services include consulting and execution of the following activities.
A.P.S. Support its clients to ensure their processes comply to the current industry and regulatory requirements and stream lined for the optimum performance. our services include consulting and execution of the following activities.
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Process Mapping
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Regulatory and cGMP Gap assessment.
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Risk assessment.
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Process improvement and re-engineering
A.P.S. Provides the following services to maintain its clients quality system.
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Concepcion of Investigation, CAPA and Change Control systems and their automation.
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Performing Investigations.
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CAPA determination and analysis.
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Evaluating the CAPA efficiency.
A.P.S. has developed the following management tools in order to support its client's operations..
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LIMS Laboratory Information Management System.
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Equipment Management System
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GMP Excel environment (to validate Excel worksheets)