Providing Life Sciences companies with a reliable approach to important documentation of job-related data
JDXpert is an easy-to-use Job Description Management tool that provides Life Sciences companies with a reliable approach to important documentation of job-related data.
Under 21 CFR Part 11, FDA-regulated organizations must assure the integrity of their electronic data, making certain that these records and any electronic signatures are as reliable as their paper-based counterparts.
Generate accurate and complete copies of records in both human readable and electronic form suitable for inspection and review by the agency
Protect job-related data with safeguards like nightly back-ups, role-based security and other built-in controls
Access to secure, computer generated, time-stamped audit trails that independently record the date and time of operator entries and actions such as the creation, modification, or deletion of electronic records
Store job description acknowledgements that contain Signed By, Name, Date, Time and IP Address
Ensure controlled system access with single sign on and unique username and password capabilities
Not only does JDXpert allow you to manage and store authenticated and electronically acknowledged job descriptions, but it also keeps track of training, education and other requirements for each role. 21 CFR 820.25 requires manufacturer to have sufficient personnel with the necessary education, background, training, and experience to check that all required activities are correctly performed. Manufacturers are also required to establish procedures for identifying training needs, ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training.
Store position’s qualifications for evaluation of candidate suitability
Document training and certification requirement for each job