The main objective of using the Gap Analysis in the pharmaceutical industries is to identify the gap between the regulatory requirements governing the company operations and the current status of the company operations. This helps provide the company with insight into areas that have room for improvement. For this purpose ReguLogix provide the gap analysis service to determine, document and approve the variance between requirements and current capabilities. The next step for most companies is to determine what actions are necessary for them to be in compliance with the requirements.

Regulogix helps you assess the implemented CSV as against the 21 CFR Part 11 requirements which provide the industry with assessable information for electronic records and signatures that can be used to add weightage to the validation of automated systems. Part 11 regulations can be used to accomplish three tasks: create new requirement specifications that comply with Part 11 regulations, assess existing automated systems for Part 11 compliance, and remediate Part 11 compliance gaps in existing automated systems.

Implementing a gap analysis may have different purposes:
to determine if a system to be purchased will comply with Part 11 before purchasing it
to efficiently incorporate Part 11 compliance into your validation effort
to assess existing systems for Part 11 compliance
to remediate existing systems for Part 11 compliance

Regulogix provides efficient consultancy solutions to comply with these inevitable regulations.