Regulatory compliance

In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations. Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls. This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources.

Regulations and accrediting organizations vary among fields, with examples such as PCI-DSS and GLBA in the financial industry, FISMA for U.S. federal agencies, HACCP for the food and beverage industry, and the Joint Commission and HIPAA in healthcare. In some cases other compliance frameworks (such as COBIT) or even standards (NIST) inform on how to comply with regulations.

Some organizations keep compliance data—all data belonging or pertaining to the enterprise or included in the law, which can be used for the purpose of implementing or validating compliance—in a separate store for meeting reporting requirements. Compliance software is increasingly being implemented to help companies manage their compliance data more efficiently. This store may include calculations, data transfers, and audit trails

FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind FDA or the public. Alternative approaches may be used as long as said approaches satisfy the requirements of applicable statutes and regulations. These programs are intended for FDA personnel but are made available electronically to the public as they become available.

The FDA Compliance Program Guidance Manual listing is available at Compliance Program Guidance Manual

for more information please click here

these all are external links and are genuine links

want to contact with author then pls 

click here

or 

click here

Program No.	Compliance Program Title
7348.003	In Vivo Bioavailability-Bioequivalence Studies – Clinical
7348.004	In Vivo Bioavailability-Bioequivalence Studies – Analytical
7348.809A	Radioactive Drug Research Committee (PDF - 142KB)
7346.832	Pre-Approval Inspections/Investigations (PDF - 406KB)
7346.843	Post-Approval Audit Inspections (PDF - 152KB)
7352.002	Unapproved New Drugs (Marketed, Human, Prescription Drugs only) (PDF - 52KB) [HTML version]
7352.004	In Vitro Methods Development and Validation for Generic Drugs (Not available online)
7353.001	Postmarketing Adverse Drug Experience (PADE) Reporting Inspections
7356.002	Drug Manufacturing Inspections (PDF - 160KB)
7356.002A	Sterile Drug Process Inspections (PDF - 292KB)
7356.002B	Drug Repackers and Relabelers (PDF - 182KB)
7356.002C	Radioactive Drugs (PDF - 180KB)
7356.002E	Compressed Medical Gases (PDF - 239KB)
7356.002F	Active Pharmaceutical Ingredients (PDF - 150 KB)
7356.002M	Inspections of Licensed Biological Therapeutic Drug Products (PDF - 93KB) [HTML version]
7356.002P	Positron Emission Tomography (PDF - 183KB)
7356.008	Drug Quality Sampling and Testing - Human Drugs
7356.014	Drug Listing (Not available online)
7356.014A	Drug Listing - Labeling Review (Not available online)
7356.020	Compendial Monographs Evaluation and Development (CMED) (Not available online)
7356.020A	Compendial Methods Assessment (Not available online)
7356.021	Drug Quality Reporting System (DQRS) (MedWatch Reports) NDA Field Alert Reporting (FARs)
7356.022	Enforcement of the Drug Sample Distribution Requirements of the Prescription Drug Marketing Act (PDMA)
7361.003	OTC Drug Monograph Implementation (PDF - 51KB)
7363.001	Fraudulent Drugs (PDF - 68KB)