Manufacturing Regulatory Compliance
Keeping up with and adhering to regulations can be daunting for manufacturers. New regulations surface and old regulations get updated on a regular basis. Consequences for not following regulations can be costly. An integrated ERP system designed with regulatory compliance features takes the worry out of following regulations and keeps the focus on manufacturing.
Fail to Plan? Then Plan to Fail.
Software validation is confirmation that software specifications conform to user needs and the intended use of the software. Software validation requires objective evidence that the requirements can be consistently fulfilled. Software validation is required by any company covered by the Food, Drug and Cosmetic Act and 21 CFR Parts 210 & 211. ProcessPro® Premier provides the tools to comply with these legal requirements. If a company is keeping cGMP data electronically and relying on that information to make cGMP decisions, they are required to perform software validation. The penalties and/or fines of not complying could put a company out of business. Current Good Manufacturing Practices (cGMP) and the FDA require documented evidence that computer systems perform as intended, including: additional security, audit trail, and electronic signature requirements.
Manufacturers are experiencing increased enforcement of industry regulations by government officials. With the added costs of validation, many companies choose to take the risk and not validate their systems. However, the benefits of validating are proving to be well worth the costs. Some of the reasons for validating include:
- Saving money by discovering weaknesses or flaws in processes prior to production
- Providing management with a clear understanding of risks so that appropriate decisions can be made
- Increasing the likelihood projects will be completed on time and within budget
- Increasing product and system quality
- Meeting regulatory compliance
Comply with Multiple Regulations.
If your company must adhere to FDA, cGMP, HACCP, MSDS, FSHEA, SQF, BRC, lot tracking, and other regulations, then finding ERP software that is capable of helping you meet those requirements is the cornerstone to your compliance management strategy. ProcessPro® Premier provides the tools to meet these requirements that, in combination with your company's own standard operating procedures, help ensure that raw materials and manufactured products are safe, pure and effective, and meet industry regulations.Additional Resources:
- Industry Update: Are You Ready for a Recall?
- 10 Steps To Software Validation
- Protecting the Food Supply: FDA's Bioterrorism Act
- 6 Critical Manufacturing Challenges Resolved with an Integrated ERP
- How to Choose an ERP for Process Manufacturers
- Top 10 Reasons to Trust ProcessPro as Your Business Software Partner
- Request All Additional Resources