The Age of Electronic Accountability: How to become compliant
If your current systems are custom, heavily modified versions of packages or just old, you face a bigger challenge. You may need to replace the existing systems. Both ERP and MES vendors are now touting systems that can help you comply. Be aware that the FDA does not validate software products. Remember that software suppliers can only assist you in compliance. If a software salesperson says, "We're compliant," he or she does not understand the regulations and a red flag should go up.