With a pandemic upon us and most of us working from home, there is a challenge to meet project timelines without the in-person availability we once enjoyed. We no longer have convenient access to co-workers for questions and advice to enable us to confidently produce robust qualification documents and expedite them through the documentation system.
Many of you are using or have used some of these methods but we can always take it one step further. So, let me share a strategy that I have used for many years that is effective in any work environment.
1. Start with Understanding Your Qualification Document Requirements
Many GMP facilities will start with a systems qualification procedure or policy to outline required documents that you, the validation specialist, will need to follow. Flexibility in your policy should meet GMP requirements without building in unnecessary constraints. If you want flexibility, then you may have to surrender some conventional consistency. Don’t restrict your ability to streamline the process with mandatory document sets.
When qualifying systems without complex software systems that may require separate protocols for the validation environment and the production environment along with possible data migration requirements, combining documents will cut down on review/approval/release cycles.
Also, avoid mandatory requirements for review cycles prior to the approval cycle. There are many straightforward documents and document revisions that can go directly into approval without a review cycle. The document can be rejected in approval if necessary and resubmitted.
2. Explore Combining Documents to Save on Review/Approval Cycles
Although your experience may vary, a typical project that I encounter at many GMP clients would require documents that are ripe for streamlining that would include a functional risk assessment, qualification protocol, requirements traceability matrix, final qualification summary report, and a release report, along with other required documents that may not be candidates for combining.
Each one of these documents require representatives from multiple disciplines to review and then approve after the review comments are addressed. When policies are written to provide requirements without constraining structure then we can be creative in the construct of the documents while meeting document requirements.
Functional Risk Assessment + Qualification Protocol = 2 Fewer Review/Approval Cycles
Combine the functional risk assessment with the qualification protocol. We need to functionally risk assess each system’s requirements, which includes all user requirements specifications, to evaluate the risk and understand the level of testing needed in our qualification protocols to test each requirement.
It is also convenient to link (via the software application) the table row for your requirement to the testing steps below in the protocol without having to type in references to protocol step numbers that may change during the review process.
Qualification Summary Report + Requirements Traceability Matrix + Release Report = 4 Fewer Review/Approval Cycles
Combine the qualification summary report with the requirements traceability matrix. Not only will this save an additional document with several review cycles, but you can cut-and-paste (using conventional document applications) the table from the functional risk assessment that references where the requirements were tested in the protocol into this document. Just edit the columns in the table that pertain to risk assessing and exchange with column information that pertain to referenced associated specification and design requirements.
The referenced steps where testing occurred in the protocol already exist, saving time not having to recreate them. If you are using an automated validation software application, you can build this into your qualification templates for greater efficiency. Combining the summary report with the requirements traceability matrix also enables the reviewer/approvers not to have two separate documents to deal with.
To further shorten the process, add the release report contents in with the summary report and requirements traceability matrix. This will shorten the release time without having to wait on separate document cascading approvals. With flexible policy documents, we can shorten project deliverable dates and save on resources.
The downside? Now you will have validation projects with some systems having separate documents and some having combined documents, making this an audit nightmare. The solution is to utilize your document application and ensure that documents do not get approved unless the validation package or system number is entered into the information field for each document and that that field is searchable within the document application. And one more time just to be sure: It is essential that that all your system documents are linked by a common searchable field in the document application!
3. Develop a Library of Templates
The quality of your templates will directly impact your qualification success limiting time and effort. When developing a library of templates, the goal is to keep them modular if you want to streamline documents.
4. Don’t Skip Peer Review
Having an experienced validation colleague review your document prior to review by the other team disciplines used to be standard practice. Now we go straight to team review to presumably save time – or so we think.
You may be assigned to approve your document(s) only as the document originator, but a validation approver will also be required. Where the validation approver is somewhat familiar, if not very familiar with the project, it is extremely beneficial to have that person perform a peer review of your documents prior to submitting them for team review in the documentation application.
This may delay starting the official team review cycle by a day or so, but it is my experience that a peer review will save complications encountered in the team review cycle, translating into saved time.
5. Use Your Instant Messenger
To facilitate an expedient review and approval cycle, you will need to communicate and follow-up with team reviewer/approvers to ensure due dates are met. If not, your document(s) will find its way to the bottom of the team reviewers’ to-do lists.
All instant messenger apps have an alert or notification feature for you to tag when your team reviewers are available to message so you can gently inquire if they can review/approve your document. This is an effective, informal, and friendly nudge to keep your document(s) on their radar.
Be a mosquito! Just annoying enough to get your documents reviewed and approved, without being downright irritating.
Don’t be a hornet! This is an art that may take some practice with some team members educating you along the way as you may cross over from slightly annoying into irritating.
- Start with understanding your qualification document requirements
- Explore combining documents to save on review/approval cycles
- Develop a library of templates
- Don’t skip peer review
- Use your instant messenger
Improvise and utilize. Seek help. Communicate.
Jim has led and managed cross-functional technical teams to accomplish manufacturing objectives for production launches and continuing maintenance support. He has written and executed test protocols for FDA regulated equipment/processes and investigated and determined root cause for failures with prescriptive corrective and preventative actions. As well as validated and calibrated process, utility, and laboratory instruments, equipment, and computerized systems in GMP Facilities.