Ocuserv neglects to validate software transfer process for ophthalmic autoscan system.Software validation The certification that an information system has been implemented correctly and that it conforms to the functional specifications derived from the original requirements. Such validation is often performed by a third party consulting organization. was the principal concern noted by FDAers following a Jan. 13, 14 and 23 inspection at Ocuserv Instruments, Jamaica, NY, which resulted in a warning letter dated March 2.
Agency investigators found that the manufacturer of ultrasonic ultrasonic /ul·tra·son·ic/ (-son´ik) beyond the upper limit of perception by the human ear; relating to sound waves having a frequency of more than 20,000 Hz.
1. imaging systems--Autoscan DB 3000 and DB 3000C Biometric Rulers, Ophthalmic A-Scan Systems--had not only failed to document process validation results and activities for the devices but had neglected to validate software transfer processes.
For example, the software transfer process using the firm's ChipMaster 3000 (V.2.61) programmer had not been validated to assure that it was capable of reproducing and completely copying the master software program onto a blank chip that would subsequently be installed into the finished device, an Ophthalmic Autoscan DB 3000C System. The autoscan systems are software driven and measure the axial axial /ax·i·al/ (ak´se-al) of or pertaining to the axis of a structure or part.
1. Relating to or characterized by an axis; axile.
2. length of the eye, anterior chamber The anterior chamber is the fluid-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. Aqueous humor is the fluid that fills the anterior chamber. depth, and lens thickness plus calculate the power of an intraocular lens Intraocular lens
Lens made of silicone or plastic placed within the eye; can be corrective.
Mentioned in: Cataract Surgery that replaces the eye's natural lens after cataract surgery Cataract Surgery Definition
Cataract surgery is a procedure performed to remove a cloudy lens from the eye; usually an intraocular lens is implanted at the same time.
The purpose of cataract surgery is to restore clear vision. .
Other violations cited in the warning letter included failure to establish and maintain an adequately written Device Master Record; failure to establish the appropriate responsibility, authority and interrelation of all personnel who manage, perform and assess workaffecting quality; failure to establish, maintain and implement procedures for finished device acceptance; and failure to establish, maintain and implement procedures for acceptance of incoming products.
Moreover, Ocuserv had failed to establish procedures for quality audits; failed to ensure that manufacturing equipment was routinely calibrated cal·i·brate
tr.v. cal·i·brat·ed, cal·i·brat·ing, cal·i·brates
1. To check, adjust, or determine by comparison with a standard (the graduations of a quantitative measuring instrument): , inspected, checked and maintained; and failed to establish and maintain instructions and procedures for performing and verifying that servicing meets the specified requirements.
Other procedural failures listed in the warning letter included that no written procedures were established directing the maintenance of service records; there were no procedures for receiving, reviewing and evaluating complaints by a formally designated unit; there were no procedures for implementing corrective and preventative actions; there were no procedures for addressing the identification, documentation, evaluation, segregation, disposition and investigation of all non-conforming device products; and there were no procedures for component acceptance activities or for the control, approval and distribution of all documents.
In a telephone interview, Ocuserve President Moshko Fuchs said: "We are at this time working closely with FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. to address all of the issues in the letter." Doc. 12910W