Chemical and agrochemical manufacturers are encountering more challenges than ever before, including new chemical manufacturing regulatory requirements, mergers and acquisitions, patent expirations, competition, product registration tracking and a global network of suppliers and third-party vendors that need to adhere to an organization’s product quality and safety requirements. These challenges come at a time when there is less budget, reduced headcount, and minimal visibility to global and contract chemical manufacturing and packaging processes.
Companies in these industries rely on disparate ERP, MES, and other IT systems to manage operations and costs. Unfortunately, these systems do little to manage and maintain chemical and agrochemical industry quality processes and regulatory compliance, and as a result many quality processes are handled in spreadsheets or paper-based files. These methods often silo information at one location, contain errors, and prevent corrective or preventive actions from being implemented across the enterprise.
How Does an Enterprise Quality Management Software Solution Help Chemical and Agrochemical Organizations Meet Compliance Regulations?
An enterprise quality management software (EQMS) solution enables manufacturers to implement an effective and closed-loop quality and compliance system -- tracking, managing and reporting on the critical quality and regulatory processes affecting chemical and agrochemical operations such as deviations, investigations, corrective actions and preventive actions (CAPAs) and management of change (MOCs).
Chemical companies are required to meet multiple global regulatory requirements in order to distribute product on a global basis. Tracking and managing the regulations of each country – such as the US Toxic Substances Control Act (TSCA) or the EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) – or even regional requirements (i.e. California’s Green Chemistry Initiative) can be a challenge for a regulatory team juggling many priorities. Product launches and sales forecasts are dependent on maintaining and updating registration submissions and testing requirements. One change in product recipe or specification requirements can result in a product being out of compliance and thus unable to be released to open purchase orders.
By managing the product registration process within an EQMS, any changes to the product – including CAPAs or MOCs – can be identified in real-time and updates to submissions can be immediately updated with regulatory authorities to prevent distribution delays.
Sparta Systems’ best practices and more than 20 years of domain expertise – in industries such as chemical, agrochemical, personal care, food and beverage, pharmaceutical, medical device, and consumer products– can enable organizations to effectively comply with regulations that include EPA, GMP, OSHA, EPA, ISO, FIFRA, Regulation No 396, Directive 91/414/EEC, and other quality and safety requirements.
Sparta Systems can help companies in the chemical and agrochemical markets implement industry-best-practices into their EQMS to streamlined deployment lifecycle to help organizations of all sizes quickly implement a powerful EQMS to support regulatory requirements. Chemical manufacturing companies have been able to streamline quality processes, consolidate redundant systems, and reduce manual operations to improve top-line revenue generation.
- Facilitates compliance with GMP, OSHA, EPA, ISO, and other quality and safety requirements
- Supports chemical manufacturer risk management programs by proactively identifying trends and indicators for materials that are out of specifications (OOS) or out of tolerance (OOT)
- Enforces chemical and agrochemical industry standards for employee and supervisor training on proper safety procedures
- Shortens product release cycle time by closing corrective and preventive actions faster
- Improves organizational efficiency by alerting users when work is required and automatically escalating late issues
- Increases transparency through extensive reporting capabilities featuring dashboards, executive overviews and powerful search functionality