Shopify Store Link Compliance By Design QMS and SOPs
We have a package that is 50+ SOPs, forms, protocol / report templates, risk templates and more. If you paid to do this in house you'd spend months and a great deal of money just to get to a draft state. This package will need some modifications to get in alignment with your company's practices, but it's a near finished product. Call us and we can discuss your documentation needs.
Or, let us answer the questions you have about what it means to have a Quality Management System and to be a cGMP operation. Let us help you write the set of instructions to develop and keep your company on the compliant path. We have a Quality Management System you can download if you want, or we can help you write your own.
Where are you right now? We have remote auditing solutions so we can audit from a distance. We are available to guide your staff through a successful self audit.
Do you know what risk is and how to measure it? Do you understand your risk profile? This is a critical component for your company and we have a solution for you. We can help you measure risk and also help you mitigate. We've done this globally for large pharma & biotech companies and we can provide the template and training, or we can do it for you.
Do you need a specific protocol, report or SOP written for your company? Do you need a bulletproof Quality Agreement with a contract testing lab? Do you need an Analytical Method Validation Protocol, Method Transfer Master Plan, or do you monitor your method performance? We have written and proofed them all before, let us help you.
(760) 385 3627
Tell us where you are and what you think you need. If you don't know where you are, we'll help you understand. If you don't think you can afford this step right now, we can work with you, just let us know what we can do to help.
We can travel to you, only inside the US at this point and only after the COVID-19 pandemic has abated to ensure everyone's safety. We can work remotely with your groups, teams and individuals. We can be onsite to support your needs when it is safe.
We have several tiers of service, but we offer a host of consulting and "A La Carte" services. Do you need a Quality Manual? We have one. Do you need an entire QMS? We have one of those too. Do you want us to remotely audit your SOPs for Quality and Compliance? Again, we can help.
We will mix and match or customize as needed. If you want the basics, we can build that for you, if you want the end to end audit with complete mitigation, we can also do that.
We will build a custom quote for your team or organization that specifically fits your needs. We will not try to convince you that you need more than is actually necessary. We have been on the opposite side of the coin, and we don't like pushy sales pitches any more than you do.
For implementation, site visits are recommended, but due to the global pandemic, we are strongly recommending remote audits and Zoom, WebEx or Google Chat videoconferences / teleconferences.
We will be occasionally updating the levels of service as business needs dictate. Check back or contact us for non-standard requests.
