If you are facing any of these issues…
- I have new software that I need to install and get into use but I don’t know how to get started.
- I have an upgrade but I don’t know how to do change control and re-validation.
- I’m not exactly sure which documents are necessary. I don’t know how to create documents that are acceptable to my customers, QA and FDA. What training do I need to understand 21 CFR Part 11 so I can avoid 483s and Warning Letters?
- How do I manage a validation project without spending a lot of money? How much should it cost?
- Staff is busy, how can we make time to do a validation project? Which employees are needed to implement the software system?
- What has to be qualified and what has to be validated? Do I have to execute a ton of test cases? How do I validate an Excel spreadsheet?
- What is the risk-based approach to validation and how does it make my project easier? How can I save money and still get a high quality system?
- How do I know which system to buy? How do I select a vendor? How do I audit a vendor?
- What documentation does a software vendor need to pass a client audit?
- As a Software as a Service (SaaS) provider, what documentation is needed to pass an client audit?
- What is needed to qualify a virtual server (VMware, Hyper-V) environment and how does this affect validation of software applications?
…consider that David Nettleton has completed more than 240 software validation projects working step by step with the people that actually use the software. Together we fill out standard templates taken from my book. Projects are typically completed in one-third the time of any other approach. This means the system is up and running with trained users in a third of the time too. The result is increased employee efficiency and your company is now more productive. Isn’t that why you bought the computer system in the first place?
Cost-Reduction without increasing regulatory or business risk
- The 10-step risk-based approach uses fill-in-the-blank templates to capture the essential validation documentation related to: requirements, specifications, installation, risk assessment, testing, SOP, training, and system release.
- Increase corporate productivity, and individual workforce member productivity.
- Efficiently create validation documentation.
- Determine risk in a process. Write test cases that trace to elements of risk management.
- Significantly lower costs and reduce software implementation time.
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 240 mission critical laboratory, clinical, and manufacturing software implementation projects.
- Complete 21 CFR Part 11 and Annex 11 compliance related to SOPs, training, product features, and software validation.
- Services include gap analysis, remediation plans, vendor audits, and project management.
- Electronic signature, biometric signatures, digital pens.
- VMWare in regulated environments.
- Software as a Service (SaaS) compliance.