Contents

SUBCHAPTER 180 - FIELD ACCOMPLISHMENTS AND COMPLIANCE TRACKING SYSTEM (FACTS)

The Field Accomplishments and Compliance Tracking System (FACTS) is FDA's automated system for field assignments, work results, firm information, consumer complaints, compliance actions, and time reporting. FACTS incorporates assignment management and work results for the following investigational activities: sample collections, establishment inspections, domestic investigations, and field examinations. FACTS also includes detailed information concerning analytical findings and compliance activities. All these data fields can be searched and viewed by any FACTS user.

FACTS has not changed the requirements for evidence development and documentation, identification of evidence or samples, submission procedures for records collected during inspections or investigations, timeframes for submission of potential regulatory actions, or many other activities you do. Be guided by outstanding policy and procedures in the IOM in these areas. Enter all information required by policy or procedure which may go beyond the "mandatory fields" to simply store information in FACTS. Consult the IOM, Compliance Program Guidance Manual (CPGM) or Assignment for required information. FACTS does not replace hardcopy narrative reporting for things such as inspections, investigations, consumer complaint follow-up and others.

FDA has not developed a "user's manual" for FACTS. Be guided by the information you received during your FACTS training, information and instructions contained in the Data Codes Manual (DCM) and the IOM. FACTS on-line HELP is your first source of information on the functioning of FACTS and how to enter data. If additional help is necessary, users contact the local FACTS Lead Users.

Each Supervisory Investigator (SCSO), Investigator (CSO) and Inspector (CSI) has a FACTS "electronic signature". This signature is used to electronically sign sample collection, inspectional, and investigational reports in FACTS. It also provides the same legal basis for regulatory activities as a handwritten signature on a paper document. FACTS is designed to limit the ability of individuals, other than the person recording the information, to make changes to stored information, in many, but not all, cases.

You are responsible for reporting your activities and time on all reportable operations. FACTS is designed to capture all the necessary data formerly kept in the Program Oriented Data (PODS) and Manpower Utilization Systems (MUS). You are responsible for reviewing and updating information in FACTS in the "MAINTAIN FIRM" data area. This is the same information previously kept in the Official Establishment Inventory (OEI) data system. These updates should be completed when you enter data into any FACTS record or record your time for the assignment.

Since most assignments will be requested and managed within FACTS, you should check your FACTS "Inbox" at least daily. 

SUBCHAPTER 181 - OPERATIONAL AND ADMINISTRATIVE SYSTEM FOR IMPORT SUPPORT (OASIS)

The Operational and Administrative System for Import Support (OASIS), is a national database on imports, enforcement activities and findings. OASIS is designed to accomplish the following objectives:

• Make a risk assessment of incoming entry data to identify those which must be reviewed by FDA personnel and allow the others to enter commerce without further action
• Increase the productivity of investigations' personnel in the field though automated interfaces with the FDA Centers, Brokers/Filers, and the U.S. Customs Service (USCS)
• Integrate OASIS with other ORA systems to provide for seamless linkage of import and domestic functions
• Improve screening of imports by providing suggestions for actions likely to result in discovery of violations
• Provide faster turn-around for processing of importer's entries and faster and more consistent response to discovered violations and import alerts
• Provide national and district uniformity in processing of entries
• Assist compliance personnel in tracking the status of suspected violative products and information related to these products
• Provide the ability to track the performance of Private Laboratories who submit analytical work to FDA for imported products
• Automate the generation of the Notices of Action sent to firms regarding actions taken by FDA
• Provide redundant electronic notification of cargo hold/detain/release/refusal statuses to the filers via the USCS interface
• Maintain a base of information for generation of reports at the district, regional, and national level
• Adjust the regulatory strategy and screening of products based upon national database of trade patterns and sample/examination results
• Respond to congressional and management needs for information on the effectiveness of FDA programs

The system not only supports FDA field personnel in carrying-out their day-to-day activities, but also provides headquarters personnel and program staff within the FDA Centers with vital information on FDA compliance program guidance manuals and workforce accomplishments. By having national data on imports, enforcement activities and findings, FDA management is better able to spot emerging trends, identify emergency situations and alert all field personnel quickly, allocate resources more effectively, and effect greater uniformity in enforcement activities throughout the country.

Additional information about OASIS and guidance on its use can be found in IOM Chapter 6, Imports, and in the OASIS "Help" module.