Quality of life, treatments, and cures start here.
Necessity is the Mother of Invention
The medical device industry has been imperative to the growth of treatment options available to patients and practitioners of modern medicine. These companies are dedicated to developing, manufacturing, and testing products suitable for diagnosis, treatment, prevention, or cure of medical conditions or diseases. As the nature of this work necessitates, regulatory bodies have a responsibility to the public to maintain a high standard of efficacy, safety, and longevity for medical devices developed by medical device companies.
Compliance is the Guardian of Validation
Data integrity and regulatory compliance is fundamental to this responsibility. The Food and Drug Association (FDA) and other regulatory agencies have a commitment to ensure that any medical devices produced or sold are effective for their indications and safe for public use and in medical applications, with severe consequences levied to those who do not observe 21 The Code of Federal Regulation (CFR) Part 11 and other related standards. To comply with regulations enforced by these agencies, medical device companies have sought help from experts in regulatory compliance and validations to ensure the data associated with their products adheres to Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA)+ principles.
ANSA Compliance has a mission to facilitate a seamless journey to compliance and help our clients meet their business needs. We come with a highly-experienced team in laboratory operations, manufacturing processes, equipment qualification, and computer system validations, ready to use our expertise to guide your business to efficient and compliant solutions.
Our Work Embodies Integrity
Data integrity is our highest concern and will be achieved through a risk-based approach to the validation life cycle with respect to your company’s procedures and policies. Our team can lead coordination with project stakeholders and subject matter experts, perform impact assessments, draft validation documentation, and execute vigorous Installation, Operational, and Performance Qualification (IQ / OQ / PQ) testing.
ANSA is the Answer
ANSA Compliance is a service and staffing provider specializing in compliance and project management in highly regulated environments, such as the medical device industry. Our promise is to provide a full-service experience including consultation, evaluations, remediations, solutions, document authoring, and staffing to help our clients be more competitive and attain their business goals.