Quality Assurance Questions
Frequently Asked Questions
Listed below are some questions that are frequently asked by companies exploring the possibility of outsourcing some or all of their audit, inspection, or QAU responsibilities.
- Contracted auditors will be expected to audit/inspect in compliance with the sponsor company (sponsor) SOPs. How can this most easily be accomplished?
- How much investment is required to train contract auditors?
- How much lead time is required to arrange for back-up or overflow auditor support?
- What is involved in establishing a contract for audit/inspection/QAU support with BSI?
- Does BSI utilize report templates and handle audit responses?
- For which types of clients has BSI worked?
- Please describe the security in place at BSI.
- What are BSI's network and technology capabilities?
Answers to Frequently Asked Questions
1. Contracted auditors will be expected to audit/inspect in compliance with the sponsor company (sponsor) SOPs. How can this most easily be accomplished?
BSI auditors will review the sponsor SOPs prior to performing the task described in the SOPs and document the review in BSI training records. Training records at BSI will be sealed in a client-specific (not for review by other sponsors) section of our training records. The client-specific training records can be shared with the Sponsor upon request. Our auditors will participate in proficiency testing if requested by the sponsor.
If controlled copies of sponsor SOPs are supplied to BSI QAU, those original SOPs will be stored in the QAU archives. Superseded SOPs will either be returned to the sponsor or destroyed with confirmation of destruction, whichever is requested by the sponsor.
2. How much investment is required to train contract auditors?
BSI auditors have current training in Good Laboratory Practice (21 CFR Part 58) and Good Clinical Practice (human and veterinary). Formal internal training is provided on a regular basis. Representatives of BSI QAU attend outside training events as necessary to remain up-to-date concerning current trends in the industry. Generally, any necessary training will be limited to sponsor specific requirements such as SOPs as discussed in question 1 above.
3. How much lead time is required to arrange for back-up or overflow auditor support?
Lead time can vary and depends on whether the proposed work would be conducted in our offices or at the sponsor site. For work performed in our offices, we ask that sponsors inform us as soon as it is confirmed that we will be asked to audit their work. When scheduled in advance, we can frequently begin audits within a day or two of the receipt of the materials for audit.
For work conducted at the sponsor site, travel arrangements can extend the lead time by up to two weeks, although a response within a few days is possible. BSI can arrange for travel and lodging once the location and timing of any activity has been confirmed by the sponsor.
Lead time also depends on whether BSI has a current relationship with a sponsor. If BSI has an active contract with a sponsor, lead time is significantly reduced.
4. What is involved in establishing a contract for audit/inspection/QAU support with BSI?
The first step is often the establishment of terms of confidentiality that are acceptable by the sponsor. BSI routinely provides or agrees to industry standard confidentiality requirements. Once confidentiality is established, project specific materials have been provided, and project goals and deliverables have been defined, BSI can provide an estimate of time and expenses and a statement of work for projects of limited goals and duration. For projects that are less well defined, contracts can be established for audit or QAU support 'as needed'.
5. Does BSI utilize report templates and handle audit responses?
BSI will prepare audit or inspection reports using client templates or using our own internal report templates.
Audit responses will be reviewed by BSI QAU if requested by the client.
6. For which types of clients has BSI worked?
BSI has provided QAU support and audit services to pharmaceutical companies, veterinary pharmaceutical companies, biotechnology companies, medical device companies, contract testing laboratories, agricultural research sites, aquaculture research sites and clinical investigator sites. The size of our clients ranges from development stage companies to fortune 100 companies.
7. Please describe the security in place at BSI.
BSI's facility remains locked at all times and is secured with a monitored security system. BSI's Quality Assurance maintains a secured, limited access, check-in check-out quality assurance archive. Original study data maintained on-site at BSI is stored in a secured, limited access, fireproof, check-in check-out archive.
8. What are BSI's network and technology capabilities?
BSI utilizes a Local Area Network (LAN), based in a secured Computer Room of the BSI facilities at 4610 West Commercial Drive, Suite B, North Little Rock, AR. The BSI LAN services the entire company, which consists of multiple service areas and administration. Each service area has its own set of directories with no accessibility from other departments. Any access requires the user to have a valid userid and password. Passwords expire periodically and cannot be immediately reused. All accounts belonging to other than study-related personnel are restricted and have no direct access to study data files.
BSI LAN servers and workstations run on Microsoft Windows® operating systems and include Microsoft Office® and Adobe Acrobat® software. Data is backed up nightly to an on-premises backup device and replicated offsite to a secure cloud storage facility for disaster recovery purposes. BSI also has scanning capability to create digital copies of paper documents for electronic document communication and digital backup.