Together, we are changing lives.
Leading in Safety, Efficacy, and Compliance
The pharmaceutical industry is composed of many organizations that develop, manufacture, and test drugs needed to cure, vaccinate, or alleviate patients suffering from the ails of the human experience. As a pillar of the practice of medicine, the pharmaceutical industry has been a leader in conceptualizing and implementing measures to ensure patient safety, including data integrity.
Data Integrity is Integral to Success
Data integrity and regulatory compliance is what can make or break a drug manufacturing or drug testing facility. The Food and Drug Association (FDA) and other regulatory agencies have a commitment to ensure that any drugs produced or sold are effective for their indications and safe for public consumption, with fierce penalties for those who do not abide. To comply with regulations enforced by these agencies, pharmaceutical companies have sought help from experts in the pharmaceutical compliance and validation sector to ensure the data associated with their products align with 21 The Code of Federal Regulations (CFR) Part 11 and Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA)+ principles, guaranteeing unadulterated drugs are brought to the marketplace.
Compliance is Our Cause
ANSA 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. Our team is ready to use our expertise to guide your business to efficient and compliant solutions.
Data integrity is our highest concern and will be achieved through a risk-based approach through 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 resource support provider specializing in compliance and project management in the pharmaceutical industry. Our promise is to provide a full-service experience including consultation, evaluations, remediations, solutions, document authoring, and enlisting experienced professionals to help our clients be more competitive and attain their business goals.