Deacom, Inc. recently announced it has developed a streamlined process for Title 21 CFR Part 11 validation.
“The single system solution paired with Deacom’s streamlined process for validation is greatly impacting the ease of validation for its clients, current and future,” explained Deacom President Jay Deakins. “Traditionally, ERP vendors provide an integrated solution by bolting together multiple systems. When two pieces of metal are welded together, the most common failure point is right on the weld. Likewise, the most common point of failure for ERP software is where it links to other systems. Deacom has taken a unique approach to solving this problem by developing all of the required functionality in house.”
DEACOM, the only single system ERP solution on the market, has been selected by a number of companies going through FDA validation due to its unique ability to provide all of the functional requirements needed for compliance in a single system.
DEACOM software offers capabilities that include:
- Formula management that allows users to track revisions to formulas, understand by individual batch exactly how a product was made, monitor any changes in quality, quantity and location, and provide an audit trail throughout the revisions.
- Ingredient traceability throughout the supply chain and throughout a given product’s life cycle.
- Warehouse Management that allows users to instantly track changes and report on inventory status and lot tracking through multiple facilities
- Extensive quality control including purchasing and production QC testing, stability testing and electronic signatures
- To maintain FDA compliance, users can set triggers to monitor expiration dates, inventory levels, and quality control test points; preventing improper use of inventory throughout the warehouse.
- Advanced Regulatory Reporting including a summary, which displays part numbers, descriptions, and quantities of raw materials and ingredients to generate FDA compliant nutrition and supplement labels for packages, MSDS reports and COA documents.
“DEACOM is tailored to the pharmaceutical industry. It requires no third party bolt-ons or customizations, which means data does not need to go through the multiple validations required when systems are bolted together, thereby simplifying the validation process and ensuring timely and accurate results,” said Deakins. “A single system solution simply provides greater process controls. In a highly regulated industry, iron clad process control is a requirement.”