Micro Control Solutions

Overview:
We are the developers of affordable innovative quality control data management software for stability and annual product review tracking. For the last fifteen years, we have provided our clients with tools for data management, evaluation, and report generation that emphasize our principle goal of meeting our client's regulatory responsibilities.

Stability Software:
To meet the stability requirements set forth by FDA; Micro Control Solutions has developed the Stability System II software package that handles all the requirements of a full-scale stability program. Sample management, report generation, and statistical evaluations are made available through an intuitive user interface that allows the experienced and occasional user the same level of comfort. The system also maintains multilevel security that ensures 21 CFR part 11 compliance.

Annual Product Review:
To help assure product performance, FDA has enforced a policy of annual batch reviews for many years. These product reviews which are comprised of analytical results, customer complaints, product investigation, returned goods, and company policies for reviewing the data, are usually checked during FDA inspections.

The collection of the data required for these reviews has, in the past, been an end of the year project requiring many hours and allowing only an after the fact analysis of the data. With the use of a real time data analysis system, the "Annual Review" becomes a "Current Review" allowing for a more immediate reaction to production trends. Data, graphics, and statistical information are available at the click of a button. Our Annual Product Review software is 21 CFR part 11 compliant.