Certification Compliance

Assess Once, Comply to Many

Solutions offered by Alopa enables organizations to comply, align with the best practices in the industry.

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Certification Compliance at Alopa

Our Alopa team of developers, testers, process analysts, security engineers and the management team all understand and believe in compliance.Here are some standards related to Alopa’s core vertical, healthcare.

ISO 13485

It is an internationally agreed standard that sets out requirements for a quality management system specific to the medical devices industry. This helps an organization to establish and maintain effectiveness of its processes.

Delivery of safe and effective products with a strong commitment to continual improvement instills confidence in customers.

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    FDA CFR 21 PART 11

    Paperless record keeping systems

    This compliance applies to records in electronic form that are created, modified, maintained, retrieved and transmitted under any records set forth by FDA. FDA considers these records to be reliable and trustworthy equivalent to paper based records. Compliance with this regulation would ensure paperless recordkeeping systems in healthcare devices.


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    FDA QS CFR 820

    Ensures safe and effective medical devices

    This is also known as Quality System Regulation QSR which outlines current good manufacturing practice CGMP regulations that governs the methods used in design, manufacture, packaging, labeling, storage, installation and servicing of finished goods . This ensures safe and effective medical devices. Medical device manufacturers undergo FDA inspections to ensure this compliance.

    CE MARK

    Conformity with health, safety and environmental protection standards

    This is a certification mark that indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area. This marking is also found on products sold outside EEA or designed to be sold in EEA.CE marking is recognizable worldwide. It is a compliance with EU directives meeting specific standards of quality, performance and safety of products.


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    GAMP

    Ensure pharmaceutical software have the required quality

    This covers a set of principles and procedures that help ensure pharmaceutical software have the required quality. Suppliers use this to test for avoidable defects in the system and ensure quality products. It promotes system life cycle approach.