COMPLIANCE AND DOCUMENTATION

Compliance is a process to abide and adhere to regulatory requirements to run a business. An example is obtaining all required licenses and maintaining proper Documentation to meet FDA regulations in Pharmaceutical Industries in the United States. Violating the compliance of regulations may result in heavy penalties and closure of business operations depending on the violation.

To meet all the compliance requirements, most of the Business or Industrial organizations maintain Standard Operating Procedure and Policy documents, Safety Requirements, Batch records for Drug and pharmaceutical industries, Logbooks, training and record of training, etc.

There are variety of Business operations with many compliance requirements. However, we specialize and focus on compliance requirements especially for Drug and Pharmaceutical Industries with SAP as ERP implementation.

While maintaining established regulations and guidelines stipulated by FDA and global regulatory bodies, it is essential to keep documented evidence that the Equipment, process, Facilities and IT systems used in manufacturing the product works as expected to meet the intended predetermined requirements as recorded user requirements specifications. The process of documented evidence is named as validation which ensures that cGMP (Current Good manufacturing process) are followed.

The validation documentation for any SAP implementation project in FDA regulated environment in general consists as follows: