Pharmaceutical manufacturers are held to very high regulatory standards – and for good reason. CGMPs assure the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. Our software allows you to meet these high standards without compromising on speed and efficiency.
CMS is also ready for your validation efforts. In fact, we offer IQ / OQ documents for an extra fee. We can execute these documents of we can provide them, ready for execution.
Superior Dispensing Control
CMS ensures precise dispensing during both batching and packaging.
Dispensing steps can be given acceptable weight parameters. During execution, these parameters are strictly enforced to your operators.
Direct scale connectivity allows for even more precise dispensing control, as it completely eliminates errors caused by manual data entry.
21 CFR Part 11 Compliant
Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11) is a piece of legislation passed by the FDA which sets specific guidelines for electronic record keeping for drug manufacturers.
Some of the most important parts of this legislation are its guidelines for electronic signatures. Traditional pharmaceutical manufacturing requires that certain critical steps must be verified with a second signature from a supervisor on the batch record.
In accordance with FDA legislation, these second signatures are no longer necessary. This is because data taken directly from the scale itself is used as an electronic signature / verification of the step.
Forward And Reverse Traceability
With Valdata, you can quickly and easily forward and reverse trace just about every aspect of your operation from raw materials to finished goods. This also includes batch records, equipment used, personnel involved, testing performed, and so much more.
Our software was designed to meet and exceed the stringent requirements of the FDA to make you audit-ready.
Real-Time Inventory Management and Planning
CMS employs a barcoded inventory control system to keep track of your inventory on a container-level basis. This allows for a level of inventory control and accuracy that can not be achieved with traditional lot-level tracking.
Our software also has many advanced features designed to make production planning and material consumption easy. These features ensure that you are always have enough stock on hand to get orders to your customers on time every time.