Chemical Management Software Company Eliminates Paper Batch Sheets and Need for Second Checker
Valdata Systems’ Manufacturing Execution Software Provides Electronic Batch Records Validated to FDA CFR 21 Part 11
June 21, 2012: Batch record completion and review is time consuming and costly, but it is a critical and necessary component in quality and compliance. The FDA has reported that failure to comply with the FDA mandated review process is among the top ten most frequent deficiencies cited.
Historically this task has been completed via paper batch sheets which are filled out by operators during the manufacturing process, then checked for accuracy by a neutral second checker. This process opens companies to a host of errors and audit nightmares. How do you know that everything was recorded? How do you verify if what the operator recorded is correct? What happens when a batch sheet is lost? Valdata Systems has released a Manufacturing Execution software package which solves these dilemmas.
Software which generates electronic batch records has been around for some time, but typically it stops at generating a record which then needs to be printed and completed by hand. This fragmented form of GMP information increases the risk of non-compliance, does not significantly reduce the chance of error and increases batch record review times causing a delay in product release. To date, the results indicate that there is no real net gain, relative to traditional paper records, by applying IT in this way.[1] The answer is a system which verifies the accuracy of the process and then records the resulting data as the data is being produced.
The Manufacturing Execution portion of Valdata’s CMS (Chemical Management System software) is just one piece of a comprehensive system which creates reliable, validatable manufacturing batch records. Through its integration with Inventory Management, Recipe Management and LIMS, the software has access to all of the information necessary to police the manufacturing process and record every piece of this data in a way that is validatable to FDA CFR 21 Part 11. No manual errors, no second checker required.
About Valdata Systems
Headquartered in Fairfield, NJ, Valdata Systems is a premier provider of Chemical Management solutions specifically targeting the Pharmaceutical, Flavor & Fragrance, Nutraceutical and Chemical Manufacturing industries.
For more information on Chemical Management Systems, Inventory Control Systems, Recipe Manager and other products provided by Valdata Systems please visit:
www.valdatasystems.com
Contact Information
Tom Winter, President
Susan Balsamello, Marketing Director
Valdata Systems
www.valdatasystems.com
(888) 276-9321
